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Posts Tagged ‘Cardiovascular disease’

Cardiovascular Risk Inflammatory Marker: Risk Assessment for Coronary Heart Disease and Ischemic Stroke – Atherosclerosis

Reporter: Aviva Lev-Ari, PhD, RN

 

Updated on 10/3/2018

Treatment concentration of high-sensitivity C-reactive protein

Published:November 13, 2017DOI:https://doi.org/10.1016/S0140-6736(17)32865-9

Interleukin 1β has multiple potential mechanisms that contribute to the pathogenesis of atherothrombotic cardiovascular disease.

Induction of interleukin 6 leads to the release of acute phase reactants including hsCRP. Thus, hsCRP serves as a surrogate marker of the overall inflammatory milieu,

often in situations where patients have multiple co-morbidities,

with a cumulative dose-response indicating a higher risk.

References

  • Ridker PM
  • Everett BM
  • Thuren T
  • et al.
Antiinflammatory therapy with canakinumab for atherosclerotic disease.

N Engl J Med. 2017; 377: 1119-1131

  • Libby P
Interleukin-1 beta as a target for atherosclerosis therapy: biological basis of CANTOS and beyond.

J Am Coll Cardiol. 2017; 70: 2278-2289

  • Pokharel Y
  • Sharma PP
  • Qintar M
  • et al.
High-sensitivity C-reactive protein levels and health status outcomes after myocardial infarction.

Atherosclerosis. 2017; 266: 16-23

  • Wang A
  • Liu J
  • Li C
  • et al.
Cumulative exposure to high-sensitivity C-reactive protein predicts the risk of cardiovascular disease.

J Am Heart Assoc. 2017; 6: e005610

    • Ridker PM
    • MacFadyen JG
    • Everett BM
    • et al.

on behalf of the CANTOS Trial Group

Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial.

Lancet. 2017; (published online Nov 13.)

SOURCE

 

 

 

 

Cardiovascular Risk Inflammatory Marker: Risk Assessment for Coronary Heart Disease and Ischemic Stroke – Atherosclerosis.

 

Watch VIDEO

webinar

Lp-PLA2 Overview Webinar

Source: http://www.plactest.com/healthcare/webinar

Watch VIDEO

 american-heart-association-2007-lppla2-highlights

American Heart Association 2007 Lp-PLA2 Presentation

Source: http://www.plactest.com/healthcare/american-heart-association-2007-lppla2-highlights

diaDexus’s PLAC, the test measuting Lp-PLA2 as a novel and valuable cardiovascular risk inflammatory marker a vascular-specific inflammatory marker implicated in the formation of rupture-prone plaque, and is the only blood test cleared by the FDA to assess risk for coronary heart disease and ischemic stroke associated with atherosclerosis. (2003 and in 2005 received additional clearance as an aid in the assessment of risk for ischemic stroke associated with atherosclerosis.)

 

In 2007 the PLAC Test was granted a Category I CPT Code (83698) by the American Medical Association and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) with a National Limitation Amount (NLA) of $47.77 in the 2011 CMS Clinical Laboratory Fee Schedule.

In July 2010, diaDexus completed a reverse merger with VaxGen. diaDexus currently trades on the OTC Bulletin Board (DDXS.OB).

 

PLAC Test is an alternative to C- Reactive Protein Test

 

The PLAC® Test is a simple blood test to detect Lp-PLA2 in the bloodstream. It is used to help predict risk for coronary heart disease and ischemic stroke associated with atherosclerosis.

 

  • The PLAC Test measures Lp-PLA2
    (lipoprotein-associated phospholipase A2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis, not stenosis, that causes the majority of cardiac events.
  • A substantial body of evidence, including over 100 studies and abstracts in peer-reviewed journals and conferences, support Lp-PLA2 as a cardiovascular risk marker that provides new information, over and above traditional risk factors.
  • Consistent with ATP III and European guidelines, the PLAC Test should be used as an adjunct to traditional risk factor assessment to identify which moderate or high risk patients, as initially assessed by traditional risk factors, may actually be at higher risk.
  • An elevated PLAC Test may indicate a need for more aggressive patient management.
    • 50% of cardiovascular events strike in patients with unremarkable lipid levels, highlighting the prevalence of hidden cardiovascular risk.
    • LDL-C and total cholesterol have proven not to be reliable predictors of stroke; the PLAC Test addresses this unmet clinical need.
  • Lipid lowering therapies, including statins, are proven to reduce cardiovascular events regardless of baseline LDL-C levels.

 

Basic Science of Lp-PLA2

The PLAC® Test measures Lp-PLA2 (lipoprotein-associated phospholipase A2) a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis that cause the majority of cardiac events, not stenosis.

 

 

 

 

Lp-PLA2 is a calcium-independent serine lipase that is associated with both low-density lipoprotein (LDL) and, to a lesser extent, high-density lipoprotein (HDL) in human plasma and serum and is distinct from other phospholipases such as cPLA2 and sPLA2. Lp-PLA2 is produced by macrophages and other inflammatory cells and is expressed in greater concentrations in advanced atherosclerotic lesions than early-stage lesions.

 

Lp-PLA2 has demonstrated modest intra- and inter-individual variation, commensurate with other cardiovascular lipid markers and substantially less than C-reactive protein (CRP). In addition, Lp-PLA2 is not elevated in systemic inflammatory conditions, and may be a more specific marker of vascular inflammation. The relatively small biological variation of Lp-PLA2 and its specificity are of value in the detection and monitoring of cardiovascular risk.

SOURCE:

http://www.plactest.com/healthcare/basic-science.html

 

 

Clinical Utility of the PLAC Test

 

The PLAC® Test Measures Lp-PLA2, a Unique Marker  
The PLAC Test for Lp-PLA2 is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The PLAC Test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific biomarker implicated in the formation of rupture-prone plaque. The majority of all heart attacks and strokes are caused by plaque rupture and thrombosis (clots) – not stenosis (narrowing of arteries).

Lp-PLA2 is a unique marker for vascular-specific inflammation and is produced by macrophages in inflamed plaque. Lp-PLA2 provides additive risk information when combined with other markers such as hs-CRP to help you personalize your treatment options, beyond the limitations of the traditional cardiovascular (CV) risk factors.

The PLAC Test Helps Identify Hidden Risk
Lp-PLA2 is an independent risk marker for stroke. At every level of blood pressure, an Lp-PLA2 value above the median almost doubles the risk for stroke.  Current stroke guidelines include consideration of Lp-PLA2 measurement in asymptomatic patients to identify those who may be at increased risk of stroke.

The PLAC Test Helps Improve Patient Management 
Periodic measurement of the amount of Lp-PLA2 in the blood for patients with 2 or more CVD risk factors can aid clinical decisions for at-risk patients, allowing you to assess or reassess the effect of lipid lowering therapies on vascular inflammation, intensify therapeutic lifestyle changes, and reinforces doctors’ recommendations for patient management.

 

 

 

 

Essential Information to Guide Treatment

In accordance with ATP III Guidelines, patients with 2 or more CV risk factors may be candidates for advanced lipid testing.

Measure the amount of Lp-PLA2 in your patient’s blood stream with the PLAC Test to determine whether they may be at increased risk for heart attack or stroke.

If the PLAC Test results are 200 ng/mL or greater, cardiovascular disease may be present. Review your patient’s advanced lipid panel results to determine where more aggressive patient management may be needed.

 

* additional reduction of Lp-PLA2 seen when added to statin therapy.

Based on:

Shalwitz R, et al. ATVB Annual Mtg. 2007.

Kuvin J, et al. Am J Cardiol. 2006.

Albert M, et al. Atherosclerosis 2005.

Schaefer EJ, et al. Am J Cardiol. 2005.

Saougos VG, et al. ATVB 2007.

Muhlestein JB, et al. JACC 2006.

      Early detection and more aggressive treatment can help prevent cardiovascular events.


 

SOURCE:

http://www.plactest.com/Default.aspx?PageID=4620488&A=PrinterView

 

 

REFERENCES

 

Pathophysiology and Genetics Studies

 

A Twin Study of Heritability of Plasma Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Mass and Activity
Lenzini L, Antezza K, Caroccia B, Wolfert RL, Szczech R, Cesari M, Narkiewicz K, Williams CJ, Rossi GP. A Twin Study of Heritability of Plasma Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Mass and Activity. Atherosclerosis. 2009; 205(1): 181-5.

Enhanced Expression of Lp-PLA2 and Lysophosphatidylcholine in Symptomatic Carotid Atherosclerotic Plaque
Mannheim D, Herrmann J, Versari D, Gössl M, Meyer FB, McConnell JP, Lerman LO, Lerman A. Enhanced Expression of Lp-PLA2 and Lysophosphatidylcholine in Symptomatic Carotid Atherosclerotic Plaque. Stroke. 2008; 39: 1448-55.

Expression of Lipoprotein-Associated Phospholipase A2 in Carotid Artery Plaques Predicts Long-term Cardiac Outc
Herrmann J, Mannheim D, Wohlert C, Versari D, Meyer FB, McConnell JP, Gössl M, Lerman LO, Lerman A. Expression of Lipoprotein-Associated Phospholipase A2 in Carotid Artery Plaques Predicts Long-term Cardiac Outcome. Eur. Heart J. 2009 Dec; 30(23): 2930-8.

Lipoprotein-Associated Phospholipase A2 is an Independent Marker for Coronary Endothelial Dysfunction in Humans
Yang EH, McConnell JP, Lennon RJ, Barsness GW, Pumper G, Hartman SJ, Rihal CS, Lerman LO, Lerman A. Lipoprotein-Associated Phospholipase A2 is an Independent Marker for Coronary Endothelial Dysfunction in Humans. Arterioscler Thromb Vasc Biol. 2006; 26(1): 106-11.

Lipoprotein-Associated Phospholipase A2 Protein Expression in the Natural Progression of Human Coronary Atherosclerosis
Kolodgie FD, Burke AP, Skorija KS, Ladich E, Kutys R, Makuria AT, Virmani R. Lipoprotein-Associated Phospholipase A2 Protein Expression in the Natural Progression of Human Coronary Atherosclerosis. Arterioscler Thromb Vasc Biol. 2006; 26: 2523-9.

 

Therapeutic Modulation Studies

 

Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial.
Robins SJ, Collins D, JJ, Bloomfield HE, Asztalos BF. Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial. Arterioscler Thromb Vasc Biol. 2008; 28(6): 1172-8.

Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial
White HD, Simes J, Barnes, E et al. Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial. Circulation, abstract 14857, AHA 2011

Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2
Saougos VG, Tambaki AP, Kalogirou M, Kostapanos M, Gazi IF, Wolfert RL, Elisaf M, Tselepis AD. Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2. Arterioscler Thromb Vasc Biol. 2007; 27: 2236-43.

Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects
Schaefer EJ, McNamara JR, Asztalos BF, Tayler T, Daly JA, Gleason JL, Seman LJ, Ferrari A, Rubenstein JJ. Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects. Am J Cardiol. 2005; 95: 1025-32.

Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease
Kuvin JT, Dave DM, Sliney KA, Mooney P, Patel AR, Kimmelstiel CD, Karas RH. Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease. Am J Cardiol. 2006; 98: 743-5.

Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial.
Robins SJ, Collins D, JJ, Bloomfield HE, Asztalos BF. Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial. Arterioscler Thromb Vasc Biol. 2008; 28(6): 1172-8.

Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial
White HD, Simes J, Barnes, E et al. Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial. Circulation, abstract 14857, AHA 2011

Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2
Saougos VG, Tambaki AP, Kalogirou M, Kostapanos M, Gazi IF, Wolfert RL, Elisaf M, Tselepis AD. Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2. Arterioscler Thromb Vasc Biol. 2007; 27: 2236-43.

Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects
Schaefer EJ, McNamara JR, Asztalos BF, Tayler T, Daly JA, Gleason JL, Seman LJ, Ferrari A, Rubenstein JJ. Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects. Am J Cardiol. 2005; 95: 1025-32.

Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease
Kuvin JT, Dave DM, Sliney KA, Mooney P, Patel AR, Kimmelstiel CD, Karas RH. Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease. Am J Cardiol. 2006; 98: 743-5.

Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial.
Robins SJ, Collins D, JJ, Bloomfield HE, Asztalos BF. Cardiovascular Events With Increased Lipoprotein-Associated Phospholipase A2 and Low High-Density Lipoprotein-Cholesterol. The Veterans Affairs HDL Intervention Trial. Arterioscler Thromb Vasc Biol. 2008; 28(6): 1172-8.

Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial
White HD, Simes J, Barnes, E et al. Changes in Lp-PLA2 activity in secondary prevention predict coronary events and treatment effect by pravastatin in long term intervention with pravastatin in ischemic disease (LIPID) Trial. Circulation, abstract 14857, AHA 2011

Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2
Saougos VG, Tambaki AP, Kalogirou M, Kostapanos M, Gazi IF, Wolfert RL, Elisaf M, Tselepis AD. Differential Effect of Hypolipidemic Drugs on Lipoprotein-Associated Phospholipase A2. Arterioscler Thromb Vasc Biol. 2007; 27: 2236-43.

Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects
Schaefer EJ, McNamara JR, Asztalos BF, Tayler T, Daly JA, Gleason JL, Seman LJ, Ferrari A, Rubenstein JJ. Effects of Atorvastatin Versus Other Statins on Fasting and Postprandial C-Reactive Protein and Lipoprotein-Associated Phospholipase A2 in Patients With Coronary Heart Disease Versus Control Subjects. Am J Cardiol. 2005; 95: 1025-32.

Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease
Kuvin JT, Dave DM, Sliney KA, Mooney P, Patel AR, Kimmelstiel CD, Karas RH. Effects of Extended-Release Niacin on Lipoprotein Particle Size, Distribution, and Inflammatory Markers in Patients With Coronary Artery Disease. Am J Cardiol. 2006; 98: 743-5.

 

 

 

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Author and Reporter: Anamika Sarkar, Ph.D.

Among many important roles of Nitric oxide (NO), one of the key actions is to act as a vasodilator and maintain cardiovascular health. Induction of NO is regulated by signals in tissue as well as endothelium.

Importance of NO has been nicely reviewed in the article  “Discovery of NO and its effects of vascular biology”. Other articles which are good readings for the importance of NO are  – a) regulation of glycolysis b) NO in cardiovascular disease c) NO and Immune responses Part I and Part II d) NO signaling pathways (Also, please see Source for more articles on NO and its significance).

The rate of production of NO has been established to be dependent on Wall Shear Stress (WSS) (Mashour and Broock, Brain Res., 1999) . Many mathematical models have been developed as 2D diffusion models to predict distribution of NO transport in single vessels, eg. arterioles (Please see Sources for references ).

Chen et. al. (Med. Biol. Eng. Comp., 2011) developed a 3-D model consisting of two branched arterioles and nine capillaries surrounding the vessels. Their model not only takes into account of the 3-D volume, but also branching effects on blood flow (Please see Fig 1 and Fig 2 from Chen et. al. 2011 ).

Image

Fig. 1 Blood phase separation with vascular branching. RBC
fractional flow in daughter branch alpha is not necessarily equal
to that in branch beta

Image

The mathematical model considers dynamic characteristics related to blood flow, blood vessel structures and transport mechanism in the wall. The authors have considered effects of branching and ratio of diameters between blood vessels of parent and children to determine the fractional blood flow which gets distributed in the network. These branching effects of the vessels will also affect the blood volume or RBC (Red Blood Cell), hence NO consumption in the blood. Parameters in the model are either obtained or fitted with experimental results from literature. Their model assumes a linear relationship of NO production with wall shear stress which in turn will be regulated by blood flow determined by branching characteristics of blood vessels. Moreover, the mathematical model includes transport of NO through the blood vessels in the tissue (in the defined volume of the model) as diffusion model,. The model was solved using Finite Elements method using the software COMSOL.

Their model results show that wall shear stress changes depending upon the distribution of RBC in the microcirculations of blood vessels, which leads to differential production of NO along the vascular network. Levels of NO at vascular walls can be less in branches which receive more blood flow, due to the balance between higher consumption of NO by RBC and production of NO due to high wall stress.  Their 3-D simulations showed the importance of capillaries such that NO can be concentrated in tissues far away in distance from arterioles facilitating much controlled NO regulation.

Though, the 3-D model developed by Chen et. al., (2011) is an idealized mathematical model of blood flow with production and consumption of NO, depending upon WSS, yet it shows importance of structure of blood vessels in distributions of NO in vessels and tissues. Such a model with proper extension to larger network can give more insights into differential distributions of NO as a function of blood flow and wall shear stress. As nano-medicine become sophisticated in years to come, information of distribution of NO in tissues and blood vessels can help the medicine to be more targeted.

Sources:

Chen et.al. (2011) : http://www.ncbi.nlm.nih.gov/pubmed/21431938

Mashour and Broock, Brain Res., 1999: http://www.ncbi.nlm.nih.gov/pubmed?term=10526117

Mathematical Modes of NO Distribution in 2-D

Other research on Nitric Oxide and Vascular Biology on this Scientific Web Site include the following:

Nitric Oxide and Immune Responses: Part 1

Curator and Reporter: Aviral Vatsa, 10/18/2012

http://pharmaceuticalintelligence.com/2012/10/18/nitric-oxide-and-immune-responses-part-1/

Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

Curator: Aviva Lev-Ari, 10/19/2012

http://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

Nitric Oxide and Sepsis, Hemodynamic Collapse, and the Search for Therapeutic Options

Curator and Reporter: Larry Bernstein, MD, 10/20/2012

http://pharmaceuticalintelligence.com/2012/10/20/nitric-oxide-and-sepsis-hemodynamic-collapse-and-the-search-for-therapeutic-options/

Mitochondrial Damage and Repair under Oxidative Stress

Curator: Larry H Bernstein, MD, FCAP, 10/28/2012

http://pharmaceuticalintelligence.com/2012/10/28/mitochondrial-damage-and-repair-under-oxidative-stress/

Nitric Oxide and Immune Responses: Part 2

Curator: Aviral Vatsa, PhD, MBBS, 10/28/2012

http://pharmaceuticalintelligence.com/2012/10/28/nitric-oxide-and-immune-responses-part-2/

Differential Distribution of Nitric Oxide – A 3-D Mathematical Model

Author: Anamika Sarkar, PhD, 10/28/2012

http://pharmaceuticalintelligence.com/2012/10/28/differential-distribution-of-nitric-oxide-a-3-d-mathematical-model/

Statins’ Nonlipid Effects on Vascular Endothelium through eNOS Activation

Curator, EAW: Larry Bernstein, 10/8/2012

http://pharmaceuticalintelligence.com/2012/10/08/statins-nonlipid-effects-on-vascular-endothelium-through-enos-activation/

Nitric Oxide Nutritional remedies for hypertension and atherosclerosis. It’s 12 am: do you know where your electrons are?

Author and Reporter: Meg Baker, 10/7/2012.

http://pharmaceuticalintelligence.com/2012/10/07/no-nutritional-remedies-for-hypertension-and-atherosclerosis-its-12-am-do-you-know-where-your-electrons-are/

Inhibition of ET-1, ETA and ETA-ETB, Induction of NO production, stimulation of eNOS and Treatment Regime with PPAR-gamma agonists (TZD): cEPCs Endogenous Augmentation for Cardiovascular Risk Reduction – A Bibliography

Curator: Aviva Lev-Ari, 10/4/2012.

http://pharmaceuticalintelligence.com/2012/10/04/inhibition-of-et-1-eta-and-eta-etb-induction-of-no-production-and-stimulation-of-enos-and-treatment-regime-with-ppar-gamma-agonists-tzd-cepcs-endogenous-augmentation-for-cardiovascular-risk-reduc/

Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents August 13, 2012

Author: Aviva Lev-Ari, PhD, RN, 8/13/2012

http://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Vascular Medicine and Biology: CLASSIFICATION OF FAST ACTING THERAPY FOR PATIENTS AT HIGH RISK FOR MACROVASCULAR EVENTS Macrovascular Disease – Therapeutic Potential of cEPCs

Curator; Aviva Lev-Ari, PhD, RN, 8/24/2012

http://pharmaceuticalintelligence.com/2012/08/24/vascular-medicine-and-biology-classification-of-fast-acting-therapy-for-patients-at-high-risk-for-macrovascular-events-macrovascular-disease-therapeutic-potential-of-cepcs/

 

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Endothelial Function and Cardiovascular Disease

Pathologist and Author: Larry H Bernstein, MD, FCAP 

 

This discussion is a continuation of a series on Nitric Oxide, vascular relaxation, vascular integrity, and systemic organ dysfunctions related to inflammatory and circulatory disorders. In some of these, the relationships are more clear than others, and in other cases the vascular disorders are aligned with serious metabolic disturbances. This article, in particular centers on the regulation of NO production, NO synthase, and elaborates more on the assymetrical dimethylarginine (ADMA) inhibition brought up in a previous comment, and cardiovascular disease, including:

Recall, though, that in SIRS leading to septic shock, that there is a difference between the pulmonary circulation, the systemic circulation and the portal circulation in these events. The comment calls attention to:
Böger RH. Asymmetric dimethylarginine, an endogenous inhibitor of nitric oxide synthase, explains the ‘L-arginine paradox’ and acts as a novel cardiovascular risk factor. J Nutr 2004; 134: 2842S–7S.

This observer points out that ADMA inhibits vascular NO production at concentrations found in pathophysiological conditions (i.e., 3–15 μmol/l); ADMA also causes local vasoconstriction when it is infused intra-arterially. ADMA is increased in the plasma of humans with hypercholesterolemia, atherosclerosis, hypertension, chronic renal failure, and chronic heart failure.

Increased ADMA levels are associated with reduced NO synthesis as assessed by impaired endothelium-dependent vasodilation. We’ll go into that more with respect to therapeutic targets – including exercise, sauna, and possibly diet, as well as medical drugs.

It is remarkable how far we have come since the epic discovery of 17th century physician, William Harvey, by observing the action of the heart in small animals and fishes, proved that heart receives and expels blood during each cycle, and argued for the circulation in man. This was a huge lead into renaissance medicine. What would he think now?

Key Words: eNOS, NO, endothelin, ROS, oxidative stress, blood flow, vascular resistance, cardiovascular disease, chronic renal disease, hypertension, diabetes, atherosclerosis, MI, exercise, nutrition, traditional chinese medicine, statistical modeling for targeted therapy.

Endothelial Function
The endothelium plays a crucial role in the maintenance of vascular tone and structure by means of eNOS, producing the endothelium-derived vasoactive mediator nitric oxide (NO), an endogenous messenger molecule formed in healthy vascular endothelium from the amino acid precursor L-arginine. Nitric oxide synthases (NOS) are the enzymes responsible for nitric oxide (NO) generation. The generation and actions of NO under physiological and pathophysiological conditions are exquisitely regulated and extend to almost every cell type and function within the circulation. While the molecule mediates many physiological functions, an excessive presence of NO is toxic to cells.

The enzyme NOS, constitutively or inductively, catalyses the production of NO in several biological systems. NO is derived not only from NOS isoforms but also from NOS-independent sources. In mammals, to date, three distinct NOS isoforms have been identified:

  1. neuronal NOS (nNOS),
  2. inducible NOS (iNOS), and
  3. endothelial NOS (eNOS).

The molecular structure, enzymology and pharmacology of these enzymes have been well defined, and reveal critical roles for the NOS system in a variety of important physiological processes. The role of NO and NOS in regulating vascular physiology, through neuro-hormonal, renal and other non-vascular pathways, as well as direct effects on arterial smooth muscle, appear to be more intricate than was originally thought.

Vallance et al. described the presence of asymmetric dimethylarginine (ADMA) as an endogenous inhibitor of eNOS in 1992. Since then, the role of this molecule in the regulation of eNOS has attracted increasing attention.
Endothelins are 21-amino acid peptides, which are active in almost all tissues in the body. They are potent vasoconstrictors, mediators of cardiac, renal, endocrine and immune functions and play a role in bronchoconstriction, neurotransmitter regulation, activation of inflammatory cells, cell proliferation and differentiation.

Endothelins were first characterised by Yanagisawa et al. (1988). The three known endothelins ET-1, -2 and -3 are structurally similar to sarafotoxins from snake venoms. ET-1 is the major isoform generated in blood vessels and appears to be the isoform of most importance in the cardiovascular system with a major role in the maintenance of vascular tone.

The systemic vascular response to hypoxia is vasodilation. However, reports suggest that the potent vasoconstrictor endothelin-1 (ET-1) is released from the vasculature during hypoxia. ET-1 is reported to augment superoxide anion generation and may counteract nitric oxide (NO) vasodilation. Moreover, ET-1 was proposed to contribute to increased vascular resistance in heart failure by increasing the production of asymmetric dimethylarginine (ADMA).

A study investigated the role of ET-1, the NO pathway, the potassium channels and radical oxygen species in hypoxia-induced vasodilation of large coronary arteries and found NO contributes to hypoxic vasodilation, probably through K channel opening, which is reversed by addition of ET-1 and enhanced by endothelin receptor antagonism. These latter findings suggest that endothelin receptor activation counteracts hypoxic vasodilation.

Endothelial dysfunction
Patients with Raynaud’s Phemonenon had abnormal vasoconstrictor responses to cold pressor tests (CPT) that were similar in primary and secondary RP. There were no differences in median flow-mediated and nitroglycerin mediated dilation or CPT of the brachial artery in the 2 populations. Patients with secondary RP were characterized by abnormalities in microvascular responses to reactive hyperemia, with a reduction in area under the curve adjusted for baseline perfusion, but not in time to peak response or peak perfusion ratio.

Plasma ET-1, ADMA, VCAM-1, and MCP-1 levels were significantly elevated in secondary RP compared with primary RP. There was a significant negative correlation between ET-1 and ADMA values and measures of microvascular perfusion but not macrovascular endothelial function. Secondary RP is characterized by elevations in plasma ET-1 and ADMA levels that may contribute to alterations in cutaneous microvascular function.

ADMA inhibits vascular NO production within the concentration range found in patients with vascular disease. ADMA also causes local vasoconstriction when infused intra-arterially, and increases systemic vascular resistance and impairs renal function when infused systemically. Several recent studies have supplied evidence to support a pathophysiological role of ADMA in the pathogenesis of vascular dysfunction and cardiovascular disease. High ADMA levels were found to be associated with carotid artery intima-media-thickness in a study with 116 clinically healthy human subjects. Taking this observation further, another study performed with hemodialysis patients reported that ADMA prospectively predicted the progression of intimal thickening during one year of follow-up.

In a nested, case-control study involving 150 middle-aged, non-smoking men, high ADMA levels were associated with a 3.9-fold elevated risk for acute coronary events. Clinical and experimental evidence suggests elevation of ADMA can cause a relative L-arginine deficiency, even in the presence of “normal” L-arginine levels. As ADMA is a competitive inhibitor of eNOS, its inhibitory action can be overcome by increasing the concentration of the substrate, L-arginine. Elevated ADMA concentration is one possible explanation for endothelial dysfunction and decreased NO production in these diseases.
Metabolic Regulation of L-arginine and NO Synthesis 
Methylation of arginine residues within proteins or polypeptides occurs through N-methyltransferases, which utilize S-adenosylmethionine as a methyl donor. After proteolysis of these proteins or polypeptides, free ADMA is present in the cytoplasm. ADMA can also be detected in circulating blood plasma. ADMA acts as an inhibitor of eNOS by competing with the substrate of this enzyme, L-arginine. The ensuing reduction in nitric oxide synthesis causes vascular endothelial dysfunction and, subsequently, atherosclerosis. ADMA is eliminated from the body via urinary excretion and via metabolism by the enzyme DDAH to citrulline and dimethylamine.
Supplementation with L-arginine in animals with experimentally-induced vascular dysfunction atherosclerosis improves endothelium-dependent vasodilation. Moreover, L-arginine supplementation results in enhanced endothelium-dependent inhibition of platelet aggregation, inhibition of monocyte adhesion, and reduced vascular smooth muscle proliferation. One mechanism that explains the occurrence of endothelial dysfunction is the presence of elevated blood levels of asymmetric dimethylarginine (ADMA) – an L-arginine analogue that inhibits NO formation and thereby can impair vascular function. Supplementation with L-arginine has been shown to restore vascular function and to improve the clinical symptoms of various diseases associated with vascular dysfunction.

Beneficial Effects of L-Arginine

  • Angina
  • Congestive Heart Failure
  • Hypertension
  • Erectile dysfunction
  • Sickle Cell Disease and Pulmonary Hypertension

The ratio of L-arginine to ADMA is considered to be the most accurate measure of eNOS substrate availability. This ratio will increase during L-arginine supplementation, regardless of initial ADMA concentration. Due to the pharmacokinetics of oral L-arginine and the positive results from preliminary studies, it appears supplementation with a sustained-release L-arginine preparation will achieve positive therapeutic results at lower dosing levels.

Many prospective clinical trials have shown that the association between elevated ADMA levels and major cardiovascular events and total mortality is robust and extends to diverse patient populations. However, we need to define more clearly in the future who will profit from ADMA determination, in order to use this novel risk marker as a more specific diagnostic tool.
Elimination of ADMA by way of DDAH
Asymmetric dimethylarginine (ADMA) and monomethyl arginine (L-NMMA) are endogenously produced amino acids that inhibit all three isoforms of nitric oxide synthase (NOS). ADMA accumulates in various disease states, including renal failure, diabetes and pulmonary hypertension, and its concentration in plasma is strongly predictive of premature cardiovascular disease and death. Both LNMMA and ADMA are eliminated largely through active metabolism by dimethylarginine dimethylaminohydrolase (DDAH) and thus DDAH dysfunction may be a crucial unifying feature of increased cardiovascular risk. These investigators ask whether ADMA is the underlying issue related to the pathogenesis of the vascular disorder.
They identified the structure of human DDAH-1 and probed the function of DDAH-1 both by deleting the Ddah1 gene in mice and by using DDAH-specific inhibitors that is shown by crystallography, bind to the active site of human DDAH-1. The loss of DDAH-1 activity leads to accumulation of ADMA and reduction in NO signaling. This in turn causes vascular pathophysiology, including endothelial dysfunction, increased systemic vascular resistance and elevated systemic and pulmonary blood pressure. The results suggest that DDAH inhibition could be harnessed therapeutically to reduce the vascular collapse associated with sepsis.
Methylarginines are formed when arginine residues in proteins are methylated by the action of protein arginine methyltransferases (PRMTs), and free methylarginines are liberated following proteolysis. Clear demonstration of an effect of endogenous ADMA and L-NMMA on cardiovascular physiology would be of importance, not only because of the implications for disease, but also because it would expose a link between post-translational modification of proteins and signaling through a proteolytic product of these modified proteins.
Which is it? ADMA or DDHA: Intrusion of a Genetic alteration.
The study showed that loss of DDAH expression or activity causes endothelial dysfunction, we believe that DDAH inhibition could potentially be used therapeutically to limit excessive NO production, which can have pathological effects. They then showed treated cultured isolated blood vessels with lipopolysaccharide (LPS) induced expression of the inducible isoform of NO synthase (iNOS) and generated high levels of NO, which were blocked by the iNOS-selective inhibitor 1400W and by DDAH inhibitors. Treatment of isolated blood vessels with DDAH inhibitors significantly increased ADMA accumulation in the culture medium. Treatment of isolated blood vessels with bacterial LPS led to the expected hyporeactivity to the contractile effects of phenylephrine, which was reversed by treatment with a DDAH inhibitor. The effect of the DDAH inhibitor was large and stereospecific, and was reversed by the addition of L-arginine.
In conclusion, genetic and chemical-biology approaches provide compelling evidence that loss of DDAH-1 function results in increased ADMA concentrations and thereby disrupts vascular NO signaling. A broader implication of this study is that post-translational methylation of arginine residues in proteins may have downstream effects by affecting NO signaling upon hydrolysis and release of the free methylated amino acid. This signaling pathway seems to have been highly conserved through evolution.

The crucial role of nitric oxide (NO) for normal endothelial function is well known. In many conditions associated with increased risk of cardiovascular diseases such as hypercholesterolemia, hypertension, abdominal obesity, diabetes and smoking, NO biosynthesis is dysregulated, leading to endothelial dysfunction. The growing evidence from animal and human studies indicates that endogenous inhibitors of endothelial NO synthase such as asymmetric dimethylarginine (ADMA) and NG-monomethyl-L-arginine (L-NMMA) are associated with the endothelial dysfunction and potentially regulate NO synthase.

Nitric Oxide Synthase

Asymmetric dimethylarginine (ADMA) is one of three known endogenously produced circulating methylarginines (i.e. ADMA, NG-monomethyl-L-arginine (L-NMMA) and symmetrically methylated NG, NG-dimethyl-L-arginine). ADMA is formed by the action of protein arginine methyltransferases that methylate arginine residues in proteins and after which free ADMA is released. ADMA and L-NMMA can competitively inhibit NO elaboration by displacing L-arginine from NO synthase (NOS). The amount of methylarginines is related to overall metabolic activity and the protein turnover rate of cells. Although methylarginines are excreted partly by the kidneys, the major route of elimination of ADMA in humans is metabolism by the dimethylarginine dimethylaminohydrolase enzymes[ dimethylarginine dimethylaminohydrolase-1 and -2 (DDAH)] enzymes. Inhibition of DDAH leads to the accumulation of ADMA and consequently to inhibition of NO-mediated endothelium dependent relaxation of blood vessels.
The potential role of ADMA in angina pectoris has been evaluated by Piatti and co-workers, who reported ADMA levels to be higher in patients with cardiac syndrome X (angina pectoris with normal coronary arteriograms) than in controls. According to preliminary results from the CARDIAC (Coronary Artery Risk Determination investigating the influence of ADMA Concentration) study, patients with coronary heart disease (n 816) had a higher median ADMA plasma concentration than age and sex matched controls (median 0.91 vs. 0.70 mol/l; p 0.0001). Further, in a prospective Chinese study, a high plasma ADMA level independently predicted subsequent cardiovascular adverse events (cardiovascular death, myocardial infarction, and repeated revascularization of a target vessel).

Protein detoxification pathway.

Protein detoxification pathway. (Photo credit: Wikipedia)

There are only few published findings concerning variations in human DDAH. However, polymorphisms in other genes potentially related to risk factors for endothelial dysfunction and cardiovascular events have been studied. Reduced NO synthesis has been implicated in the development of atherosclerosis. For example, there are some functionally important variants of the NOS that could affect individual vulnerability to atherosclerosis by changing the amount of NO generated by the endothelium.
There are probably several functional variations in genes coding DDAH enzymes in different populations. Some of them could confer protection against the harmful effects of elevated ADMA and others impair enzyme function causing accumulation of ADMA in cytosol and/or blood.
In a study of 16 men with either low or high plasma ADMA concentrations were screened to identify DDAH polymorphisms that could potentially be associated with increased susceptibility to cardiovascular diseases. In that study a novel functional mutation of DDAH-1 was identified; the mutation carriers had a significantly elevated risk for cardiovascular disease and a tendency to develop hypertension. These results confirmed the clinical role of DDAH enzymes in ADMA metabolism. Furthermore, it is possible that more common variants of DDAH genes contribute more widely to increased cardiovascular risk.
We found a rare variation in the DDAH-1 gene, which is associated with elevated plasma concentrations of ADMA in heterozygous mutation carriers. There was also an increased prevalence of CHD and a tendency to hypertension among individuals with this DDAH-1 mutation. These observations highlight the importance of ADMA as a possible risk factor and emphasize the essential role of DDAH in regulating ADMA levels.

ADMA Elevation and Coronary Artery Disease
Endothelial dysfunction may be considered as a systemic disorder and involves different vascular beds. Coronary endothelial dysfunction (CED) precedes the development of coronary. Endothelial dysfunction is characterized by a reduction in endogenous nitric oxide (NO) activity, which may be accompanied by elevated plasma asymmetric dimethylarginine (ADMA) levels. ADMA is a novel endogenous competitive inhibitor of NO synthase (NOS), an independent marker for cardiovascular risk.

English: Structure of asymmetric dimethylargin...

English: Structure of asymmetric dimethylarginine; ADMA; N,N-Dimethylarginine Deutsch: Asymmetrisches Dimethylarginin; N,N-Dimethyl-L-arginin; Guanidin-N,N-dimethylarginin (Photo credit: Wikipedia)

In a small study fifty-six men without obstructive coronary artery disease (CAD) who underwent coronary endothelial function testing were studied. Men with CED had significant impairment of erectile function (P ¼ 0.008) and significantly higher ADMA levels (0.50+0.06 vs. 0.45+0.07 ng/mL, P ¼ 0.017) compared with men with normal endothelial function. Erectile function positively correlated with coronary endothelial function. This correlation was independent of age, body mass index, high-density lipoprotein, C-reactive protein, homeostasis model assessment of insulin resistance index, and smoking status, suggesting that CED is independently associated with ED and plasma ADMA concentration in men with early coronary atherosclerosis.

ADMA and Chronic Renal Failure in Hepatorenal Syndrome
The concentration of SDMA was significantly higher in the patients with HRS compared to the patients without HRS and it was also higher than the values obtained from the healthy participants (1.76 ± 0.3 μmol/L; 1.01 ± 0.32 and 0.520 ± 0.18 μmol/L, respectively; p < 0.01). The concentrations of ADMA were higher in the cirrhotic patients with HRS than in those without this serious complication of cirrhosis. The concentration of ADMA in all the examined cirrhotic patients was higher than those obtained from healthy volunteers (1.35 ± 0.27 μmol/L, 1.05 ± 0.35 μmol/L and 0.76 ± 0.21 μmol/L, respectively). In the patients with terminal alcoholic liver cirrhosis, the concentrations
of ADMA and SDMA correlated with the progress of cirrhosis as well as with the development of cirrhosis complications. In the patients with HRS there was a positive correlation between creatinine and SDMA in plasma (r2 = 0.0756, p < 0.001) which was not found between creatinine and ADMA. The results demonstrate that the increase in SDMA concentration is proportionate to the progression of chronic damage of the liver and kidneys. Increased ADMA concentration can be a causative agent of renal insufficiency in patients with cirrhosis.

In patients with cirrhosis, ADMA, as well as SDMA could be markers for kidney insufficiency development. Accumulation of ADMA in plasma causes kidney
vasoconstriction and thereby retention of SDMA. Considering that ADMA has several damaging effects, it can be concluded that modulation of the activity of enzyme which participates in ADMA catabolism may represent a new therapeutic goal which is intended to reduce the progress of liver and kidney damage and thus the development of HRS.

ADMA Therapeutic Targets
Elevated plasma concentrations of the endogenous nitric oxide synthase
inhibitor asymmetric dimethylarginine (ADMA) are found in various clinical settings, including

  • renal failure,
  • coronary heart disease,
  • hypertension,
  • diabetes and
  • preeclampsia.

In healthy people acute infusion of ADMA promotes vascular dysfunction,
and in mice chronic infusion of ADMA promotes progression of atherosclerosis.
Thus, ADMA may not only be a marker but also an active player in cardiovascular disease, which makes it a potential target for therapeutic interventions.

This review provides a summary and critical discussion of the presently available data concerning the effects on plasma ADMA levels of cardiovascular drugs, hypoglycemic agents, hormone replacement therapy, antioxidants, and vitamin supplementation.
We assess the evidence that the beneficial effects of drug therapies on vascular function can be attributed to modification of ADMA levels. To develop more specific ADMA-lowering therapies, mechanisms leading to elevation of plasma ADMA concentrations in cardiovascular disease need to be better understood.

ADMA is formed endogenously by degradation of proteins containing arginine residues that have been methylated by S-adenosylmethionine-dependent methyltransferases (PRMTs). There are two major routes of elimination: renal excretion and enzymatic degradation by the dimethylarginine dimethylaminohydrolases (DDAH-1 and -2).

Oxidative stress causing upregulation of PRMT expression and/or attenuation of DDAH activity has been suggested as a mechanism and possible drug target in clinical conditions associated with elevation of ADMA. As impairment of DDAH activity or capacity is associated with substantial increases in plasma ADMA concentrations, DDAH is likely to emerge as a prime target for specific therapeutic interventions.

Cardiovascular diseases (CVD) in diabetic patients have endothelial dysfunction as a key pathogenetic event. Asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthase (NOS), plays a pivotal role in endothelial dysfunction. Different natural polyphenols have been shown to preserve endothelial function and prevent CVD. Another study assessed the effect of silibinin, a widely used flavonolignan from milk thistle, on ADMA levels and endothelial dysfunction in db/db mice.

Plasma and aorta ADMA levels were higher in db/db than in control lean mice. Silibinin administration markedly decreased plasma ADMA; consistently, aorta ADMA was reduced in silibinin-treated animals. Plasma and aorta ADMA levels exhibited a positive correlation, whereas liver ADMA was inversely correlated with both plasma and aorta ADMA concentrations. Endothelium-(NO)-dependent vasodilatation to ACh was impaired in db/db mice and was restored in the silibinin group, in accordance with the observed reduction of plasma and vascular levels of ADMA. Endothelium-independent vasodilatation to SNP was not modified by silibinin administration.

Endothelin Inhibitors
Endothelins are potent vasoconstrictors and pressor peptides and are important mediators of cardiac, renal andendocrine functions. Increased ET-1 levels in disease states such as congestive heart failure, pulmonary hypertension, acute myocardial infarction, and renal failure suggest the endothelin system as an attractive target for pharmacotherapy. A non-peptidic, selective, competitive endothelin receptor antagonist with an affinity for the ETA receptor in the subnanomolar range was administered by continuous intravenous infusion to beagle dogs, rats, and Goettingen minipigs. It caused mild arteriopathy characterised by segmental degeneration in the media of mid- to large-size coronary arteries in the heart of dog, but not rat or minipig.

The lesions only occurred in the atrium and ventricle. Frequency and severity of the vascular lesions was not sex or dose related. No effects were noted in blood vessels in other organs or tissue. Plasma concentrations at steady state, and overall exposure in terms of AUC(0–24h) were higher in minipig and rat than the dog but did not cause cardiac arteriopathy. These findings concur with those caused by other endothelin anatagonists, vasodilators and positive inotropic: vasodilating drugs such as potassium channel openers, phosphodiesterase inhibitors and peripheral vasodilators.

Results by echocardiography indicate treatment-related local vasodilatation in the coronary arteries. These data suggest that the coronary arteriopathy may be the result of exaggerated pharmacology. Sustained vasodilatation in the coronary vascular bed may alter flow dynamics and lead to increased shear stress and tension on the coronary wall with subsequent microscopic trauma. In our experience with a number of endothelin receptor antagonists, the cardiac arteriopathy was only noted in studies with multiple daily or continuous intravenous infusion inviting speculation that sustained high plasma levels are needed for development of the lesions.

Up-regulation of vascular endothelin type B (ETB) receptors is implicated in the
pathogenesis of cardiovascular disease. Culture of intact arteries has been shown to induce similar receptor alterations and has therefore been suggested as a suitable method for, ex vivo, in detail delineation of the regulation of endothelin receptors. We hypothesize that mitogen-activated kinases (MAPK) and protein kinase C (PKC) are involved in the regulation of endothelin ETB receptors in human internal mammary arteries.

The endothelin-1-induced contraction (after endothelin ETB receptor desensitization) and the endothelin ETA receptor mRNA expression levels were not altered by culture. The sarafotoxin 6c contraction, endothelin ETB receptor protein and mRNA expression levels were increased. This increase was antagonized by;

PKC inhibitors (10 μM bisindolylmaleimide I and 10 μM Ro-32-0432), and
inhibitors of the p38, extracellular signal related kinases 1 and 2 (ERK1/2) and C-jun terminal kinase (JNK) MAPK pathways
Endothelin Receptor Antagonist Tezosentan
The effects of changes in the mean (Sm) and pulsatile (Sp) components of arterial wall shear stress on arterial dilatation of the iliac artery of the anaesthetized dog were examined in the absence and presence of the endothelin receptor antagonist tezosentan (10 mg kg_1 I.V.; Ro 61-0612; [5-isopropylpyridine-2-sulphonic acid 6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(2-1H-tetrazol-5-ylpyridin-4-yl)-pyrimidin-4-ylamide]).

Changes in shear stress were brought about by varying local peripheral resistance and stroke volume using a distal infusion of acetylcholine and stimulation of the left ansa subclavia. An increase in Sm from 1.81 ± 0.3 to 7.29 ± 0.7 N m_2 (means ± S.E.M.) before tezosentan caused an endothelium-dependent arterial dilatation which was unaffected by administration of tezosentan for a similar increase in Sm from 1.34 ± 0.6 to 5.76 ± 1.4 N m_2 (means ± S.E.M.).

In contrast, increasing the Sp from 7.1 ± 0.8 to a maximum of 11.5 ± 1.1 N m_2 (means ± S.E.M.) before tezosentan reduced arterial diameter significantly. Importantly, after administration of tezosentan subsequent increases in Sp caused arterial dilatation for the same increase in Sp achieved prior to tezosentan, increasing from a baseline of 4.23 ± 0.4 to a maximum of 9.03 ± 0.9 N m_2 (means ± S.E.M.; P < 0.001). The results of this study provide the first in vivo evidence that pulsatile shear stress is a stimulus for the release of endothelin from the vascular endothelium.

Exercise and Diet
Vascular endotheliumis affected by plasma asymmetric dimethylarginine (ADMA), and it is induced by inflammatory cytokines of tumour necrosis factor (TNF)-a in vitro. Would a tight glycemic control restore endothelial function in patients with type-2 diabetes mellitus (DM) with modulation of TNF-a and/or reduction of ADMA level? In 24 patients with type-2 DM, the flow-mediated, endothelium-dependent dilation (FMD: %) of brachial arteries during reactive hyperaemia was determined by a high-resolution ultrasound method. Blood samples for glucose, cholesterol, TNF-a, and ADMA analyses were also collected from these patients after fasting. No significant glycemic or FMD changes were observed in 10 patients receiving the conventional therapy.

In 14 patients who were hospitalized and intensively treated, there was a significant decrease in glucose level after the treatment [from 190+55 to 117+21 (mean+SD) mg/dL, P , 0.01]. After the intensive control of glucose level, FMD increased significantly (from 2.5+0.9 to 7.2+3.0%), accompanied by a significant (P , 0.01) decrease in TNF-a (from 29+16 to 11+9 pg/dL) and ADMA (from 4.8+1.5 to 3.5+1.1 mM/L) levels. The changes in FMD after treatment correlated inversely with those in TNF-a (R ¼ 20.711, P , 0.01) and ADMA (R ¼ 20.717, P , 0.01) levels.
The exaggerated blood pressure response to exercise (EBPR) is an independent predictor of hypertension. Asymmetric dimethylarginine (ADMA) is an endogenous nitric oxide inhibitor and higher plasma levels of ADMA are related to increased cardiovascular risk. The aim of this study is to identify the relationship between ADMA and EBPR.

A total of 66 patients (36 with EBPR and 30 as controls) were enrolled in the study. EBPR is defined as blood pressure (BP) measurements ≥200/100 mmHg during the treadmill test. All the subjects underwent 24-h ambulatory BP monitoring. L-arginine and ADMA levels were measured using a high performance lipid chromatography technique.

The serum ADMA levels were increased in the EBPR group compared to the healthy controls (4.0±1.4 vs 2.6±1.1 μmol/L respectively, P=0.001), but L-arginine levels were similar in the 2 groups (P=0.19). The serum ADMA levels were detected as an independent predictor of EBPR (odds ratio 2.28; 95% confidence interval 1.22–4.24; P=0.002). Serum ADMA levels might play a role in EBPR to exercise.

Endothelial dysfunction occurs early in atherosclerosis in response to cardiovascular risk factors. The occurrence of endothelial dysfunction is primarily the result of reduced nitric oxide (NO) bioavailabilty. It represents an independent predictor of cardiovascular events and predicts the prognosis of the patient. Therefore, endothelial function has been identified as a target for therapeutic intervention. Regular exercise training is a nonpharmacological option to improve endothelial dysfunction in patients with cardiovascular disease by increasing NO bioavailability.

Peripheral Arterial Disease (PAD) is a cause of significant morbidity and mortality in the Western world. risk factor modification and endovascular and surgical revascularisation are the main treatment options at present. However, a significant number of patients still require major amputation. There is evidence that nitric oxide (NO) and its endogenous inhibitor asymmetric dimethylarginine (ADMA) play significant roles in the pathophysiology of PAD.

This paper reviews experimental work implicating the ADMA-DDAH-NO pathway in PAD, focusing on both the vascular dysfunction and both the vascular dysfunction and effects within the ischaemic muscle, and examines the potential of manipulating this pathway as a novel adjunct therapy in PAD.

In patients with CHF, the peripheral vascular resistance is increased via activation of the neurohormonal system, namely by autonomous sympathetic nervous system, rennin -angiotensin- aldosterone system (RAAS), and endothelin system. The vascular endothelial function in patients with CHF, mainly represented by the endothelium-dependent vasodilation, is altered.

Such alteration leads to increased vascular tone and remodeling of the blood vessels, reducing the peripheral blood flow. Hence, the amount of oxygen for the skeletal muscles is compromised, with progressive exercise intolerance. The vascular endothelial dysfunction in the CHF is mainly due to the decrease of the nitric oxide production induced by the reduced gene expression of eNOS and increased oxidative stress.

The endothelium-dependent vasodilation alteration has been virtually reported in all cardiovascular diseases. Using sauna bath as therapeutic option for CHF is not very recent, since in the 1950’s the first studies with CHF patients were conducted and the potential beneficial effect of sauna was suggested. However, some time later the studies emphasized especially its risks and recommended caution in its use for cardiac patients.

Frequently, sports medicine physicians are invited to evaluate the impact of the sauna on diseases and on health in general. Sauna can be beneficial or dangerous depending on its use. In the past few years the sauna is considered beneficial for the cardiovascular diseases’ patients, as the heart failure and lifestyle-related diseases, mainly by improving the peripheral endothelial function through the increase in cardiac output and peripheral vasodilation.

It is widely known that the vasodilators, such as angiotensin converting enzyme inhibitors, improve the CHF and increase the peripheral perfusion. Since the endothelial function is altered in CHF, the endothelium is considered as a new therapeutic target in heart failure. Hence, the angiotensin converting enzyme inhibitors and physical training improve the endothelial function in CHF patients. One of the proposed mechanisms for the alteration of the endothelium-dependent vasodilation would be through the decrease of the NO production in the peripheral vessels in CHF patients. The decrease of peripheral perfusion would decrease the shear stress. The shear stress is an important stimulus for NO production and eNOS expression. On the other hand, the heat increases the cardiac output and improves the peripheral perfusion in CHF patients. Consequently, with the cardiac output improvement in CHF patients, an increase of the shear stress, NO production and eNOS expression are expected.

Sauna bath
The sauna bath represents a heat load of 300-600 W/m2 of body surface area. The skin temperature rapidly increases to ± 40o-41oC and the thermoregulatory mechanisms are triggered. Evaporative heat transfer by sweating is the only effective body heat loss channel in dry sauna. The sweating begins rapidly and reaches its maximum level in ± 15 min. The total sweat secretion represents a heat loss of about 200 W/m2 of the body surface area. The body cannot compensate for the heat load and causing elevation of internal temperature. The skin circulation increases substantially. The skin blood flow, in the thermo-neutral condition (± 20oC) and in rest corresponding to ± 5-10% of the cardiac output, can reach ± 50-70% of the cardiac output.

Thermal therapy in 60oC produced systemic arterial, pulmonary arterial and venous vasodilation, reduced the preload and afterload and improved the cardiac output and the peripheral perfusion, clinical symptoms, life quality, and cardiac arrhythmias in CHF patients. In infants with severe CHF secondary to ventricular septal defect, the sauna therapy decreased the systemic vascular resistance and increased the cardiac output. The sauna benefits in CHF patients are possibly caused by the improvement of the vascular endothelial function and normalization of the neurohormonal system .

Ikeda et al. discovered that the observed improvements in the sauna therapy are due to the eNOS expression increase in the arterial endothelium. They later showed that the thermal therapy with sauna improves the survival of the TO-2 cardiomyopathic hamsters with CHF and, more recently, showed that the repetitive therapy with sauna increases the eNOS expression and the nitric oxide production in artery endothelium of TO-2 cardiomyopathic hamsters with CHF.
Whether n-3 polyunsaturated fatty acid (PUFA) supplementation and/or diet intervention might have beneficial influence on endothelial function was assessed using plasma levels of ADMA and L-arginine. A male population (n = 563, age 70 ± 6 yrs) with long-standing hyperlipidemia, characterized as high risk individuals in 1970–72, was included, randomly allocated to receive placebo n-3 PUFA capsules (corn oil) and no dietary advice (control group), dietary advice (Mediterranean type), n-3 PUFA capsules, or dietary advice and n-3 PUFA combined and followed for 3 years. Fasting blood samples were drawn at baseline and the end of the study.

Compliance with both intervention regimens were demonstrated by changes in serum fatty acids and by recordings from a food frequency questionnaire. No influence of either regimens on ADMA levels were obtained. However, n-3 PUFA supplementation was accompanied by a significant increase in L-arginine levels, different from the decrease observed in the placebo group (p < 0.05). In individuals with low body mass index (<26 kg/m2), the decrease in L-arginine on placebo was strengthened (p = 0.01), and the L-arginine/ADMA ratio was also significantly reduced (p = 0.04). In this rather large randomized intervention study, ADMA levels were not influenced by n-3 PUFA supplementation or dietary counselling. n-3 PUFA did, however, counteract the age related reduction in L-arginine seen on placebo, especially in lean individuals, which might be considered as an improvement of endothelial function.

Traditional Chinese Medicine

Traditional Chinese Medicine (TCM) involves a broad range of empirical testing and refinement and plays an important role in the health maintenance for people all over the world. However, due to the complexity of Chinese herbs, a full understanding of TCM’s action mechanisms is still unavailable despite plenty of successful applications of TCM in the treatment of various diseases, including especially cardiovascular diseases (CVD), one of the leading causes of death.

An integrated system of TCM has been constructed to uncover the underlying action mechanisms of TCM by incorporating the chemical predictors, target predictors and network construction approaches from three representative Chinese herbs, i.e., Ligusticum chuanxiong Hort., Dalbergia odorifera T. Chen and Corydalis yanhusuo WT Wang widely used in CVD treatment, by combined use of drug absorption, distribution, metabolism and excretion (ADME) screening and network pharmacology techniques. These studies have generated 64 bioactive ingredients and identified 54 protein targets closely associated with CVD, to clarify some of the common conceptions in TCM, and provide clues to modernize such specific herbal medicines.

Ligusticum chuanxiong Hort., Dalbergia odorifera T. Chen and Corydalis yanhusuo WT Wang
Twenty-two of 194 ingredients in Ligusticum chuanxiong demonstrate good bioavailability (60%) after oral administration. Interestingly, as the most abundant bioactive compound of Chuanxiong, Ligustilide (M120) only has an adequate OB of 50.10%, although it significantly inhibits the vasoconstrictions induced by norepinephrine bitartrate (NE) and calcium chloride (CaCl2). Indeed, this compound can be metabolized to butylidenephthalide, senkyunolide I (M156), and senkyunolide H (M155) in vivo.

The three natural ingredients produce various pharmacological activities in cerebral blood vessels, the general circulatory system and immune system including spasmolysis contraction effects, inhibitory effects of platelet aggregation and anti-proliferative activity, and thus improve the therapeutic effect on patients. Cnidilide (M93, OB = 77.55%) and spathulenol (M169, OB = 82.37%) also closely correlate with the smooth muscle relaxant action, and thereby have the strongest spasmolytic activity. Carotol (M8) and Ferulic acid (M105) with an OB of 149.03% and 86.56%, respectively, demonstrate better bioavailability compared with cnidilide and spathulenol, which show strong antifungal, antioxidant and anti-inflammatory activity.

The pharmacological activity of ferulic acid results in the improvement of blood fluidity and the inhibition of platelet aggregation, which may offer beneficial effects against cancer, CVD, diabetes and Alzheimer’s disease. As for 3-n-butylphthalide (M85, OB = 71.28%), this compound is not only able to inhibit platelet aggregation, but also decreases the brain infarct volume and enhances microcirculation, thus benefiting patients with ischemic stroke. Platelet aggregation represents a multistep adhesion process involving distinct receptors and adhesive ligands, with the contribution of individual receptor-ligand interactions to the aggregation process depending on the prevailing blood flow conditions, implying that the rheological (blood flow) conditions are an important impact factor for platelet aggregation. Moreover, thrombosis, the pathological formation of platelet aggregates and one of the biggest risk factors for CVD, occludes blood flow causing stroke and heart attack. This explains why the traditional Chinese herb Ligusticum chuanxiong that inhibits platelet aggregates forming and promotes blood circulation can be used in treatment of CVD.

Twenty-six percent (24 of 93) of the ingredients in Dalbergia odorifera meet the OB > 60% criterion irrespective of the pharmacological activity. Relatively high bioavailability values were predicted for the mainly basic compounds odoriflavene (M275, OB = 84.49%), dalbergin (M247, OB = 78.57%), sativanone (M281, OB = 73.01%), liquiritigenin (M262, OB = 67.19%), isoliquiritigenin (M259, OB = 61.38%) and butein (M241, OB = 78.38%). Interestingly, all of the six ingredients show obvious anti-inflammatory property. Butein, liquiritigenin and isoliquiritigenin inhibit cell inflammatory responses by suppressing the NF-κB activation induced by various inflammatory agents and carcinogens, and by decreasing the NF-κB reporter activity. Inflammation occurs with CVD, and Dalbergia odorifera, one of the most potent anti-cardiovascular and anti-cerebrovascular agents, exerts great anti-inflammatory activity.

Corydalis yanhusuo has gained ever-increasing popularity in today’s world because of its therapeutic effects for the treatment of cardiac arrhythmia disease, gastric and duodenal ulcer and menorrhalgia. In our work, 21% (15 of 73) of chemicals in this Chinese herb display good OB (60% or even high), and the four main effective ingredients are natural alkaloid agents.

Dehydrocorydaline blocks the release of noradrenaline from the adrenergic nerve terminals in both the Taenia caecum and pulmonary artery, and thereby inhibits the relaxation or contraction of adrenergic neurons. As for dehydrocavidine with an OB of 47.59%, this alkaloid exhibits a significant spasmolytic effect, which acts via relaxing smooth muscle.

In recent years, CVD has been at the top list of the most serious health problems. Many different types of therapeutic targets have already been identified for the management and prevention of CVD, such as endothelin and others. The key question asked is

  • what the interactions of the active ingredients of the Chinese herbs are with their protein targets in a systematic manner and
  • how do the corresponding targets change under differential perturbation of the chemicals?

The study used an unbiased approach to probe the proteins that bind to the small molecules of interest in CVD on the basis of the Random Forest (RF) and Support Vector Machine (SVM) methods combining the chemical, genomic and pharmacological information for drug targeting and discovery on a large scale. Applied to 64 ingredients derived from the three traditional Chinese medicines Dalbergia odorifera, Ligusticum chuanxiong and Corydalis yanhusuo, which show good OB, 261 ligand-target interactions have been constructed, 221 of which are enzymes, receptors, and ion channels. This indicates that chemicals with multiple relative targets are responsible for the high interconnectedness of the ligand-target interactions. The promiscuity of drugs has restrained the advance in recent TCM, because they were thought to be undesirable in favor of more target-specific drugs.

Target Identification and Validation
To validate the reliability of these target proteins, the researchers performed a docking analysis to select the ligand-protein interactions with a binding free energies of ≤−5.0 kcal/mol, which leads to the sharp reduction of the interaction number from 5982 to 760. These drug target candidates were subsequently subject to PharmGkb (available online: http://www.pharmgkb.org; accessed on 1 December 2011), a comprehensive disease-target database, to investigate whether they were related to CVD or not, and finally, 54 proteins were collected and retained.

Fourty-two proteins (76%) were identified as the targets of Ligusticum chuanxiong, such as dihydrofolate reductase (P150), an androgen receptor (P210) and angiotensin-converting enzyme (P209) that were involved in the development of CVD. Of the proteins, seven and two were recognized as those of Dalbergia odorifera and Corydalis yanhusuo, respectively. For Dalbergia odorifera, this Chinese herb has 48 potential protein targets, 13 of which have at least one link to other drugs.

The three herbs share 29 common targets, accounting for 52.7% of the total number. Indeed, as one of the most important doctrines of TCM
abstracted from direct experience and perception, “multiple herbal drugs for one disease” has played an undeniable role. These studies explored the targets of the three Chinese herbs, indicating that these drugs target the same targets simultaneously and exhibit similar pharmacological effects on CVD. This is consistent with the theory of “multiple herbal drugs for one disease”.

The three Chinese herbs possess specific targets. The therapeutic efficacy of a TCM depends on multiple components, targets and pathways. The complexity becomes a huge obstacle for the development and innovation of TCM. For example, the Chinese herb Ligusticum chuanxiong identifies the protein caspase-3 (P184), a cysteinyl aspartate-specific protease, as one of its specific targets, and exhibits inhibitory effects on the activity of this protease. In fact, connective tissue growth factor enables the activation of caspase-3 to induce apoptosis in human aortic vascular smooth muscle cells.

Thus, modulation of the activity of caspase-3 with Ligusticum chuanxiong suggests an efficient therapeutic approach to CVD. The Chinese herb Dalbergia odorifera has the α-2A adrenergic receptor (P216) as its specific target and probably blocks the release of this receptor, and thus influences its action. As for Corydalisyanhusuo, the protein tyrosine-protein kinase JAK2 (P9) is the only specific target of this Chinese herb. The results indicate different specific targets possessed by the three Chinese herbs.

Ligand-Candidate Target and Ligand-Potential Target Networks
Previous studies have already reported the relationships of the small molecules with CVD, which indicates the reliability of our results [45,46]. Regarding the candidate targets, we have found that prostaglandin G/H synthase 2 (P46) and prostaglandin G/H synthase 1 (P47) possess the largest number of connected ingredients. Following are nitric-oxide synthase, endothelial (P66) and tyrosine-protein phosphatase non-receptor type 1 (P8), which have 62 and 61 linked chemicals, respectively.
The 29 targets shared by the three traditional Chinese herbs exhibit a high degree of correlations with CVD, which further verifies their effectiveness for the treatment of CVD. These results provide a clear view of the relationships of the target proteins with CVD and other related diseases, which actually link the Chinese herbs and the diseases via the protein targets. This result further explains the theory of “multiple herbal drugs for one disease” based on molecular pharmacology.

Target-Pathway Network
Cells communicate with each other using a “language” of chemical signals. The cell grows, divides,or dies according to the signals it receives. Signals are generally transferred from the outside of the cell. Specialized proteins are used to pass the signal—a process known as signal transduction. Cells have a number of overlapping pathways to transmit signals to multiple targets. Ligand binding in many of the signaling proteins in the pathway can change the cellular communication and finally affect cell growth and proliferation. The authors extracted nine signal pathways closely associated with CVD in PharmGkb (available online: http://www.pharmgkb.org; accessed on 1 December 2011).

As the main components in the VEGF system, proto-oncogene tyrosine-protein kinase Src, eNOS, and hsp90-α is also recognized as common targets of Dalbergia odorifera, Ligusticum chuanxiong and Corydalis yanhusuo, which are efficient for the treatment of CVD. This implies that the candidate drugs can target different target proteins involved in the same or different signal pathways, and thereby have potential effects on the whole signal system.

Target Prediction
In search of the candidate targets, the model that efficiently integrates the chemical, genomic and pharmacological information for drug targeting and discovery on a large scale is based on the two powerful methods Random Forest (RF) and Support Vector Machine (SVM). The model is supported by a large pharmacological database of 6511 drugs and 3999 targets extracted from the DrugBank database (available online: http://drugbank.ca/; accessed on 1 June 2011), and shows an impressive performance of prediction for drug-target interaction, with a concordance of 85.83%, a sensitivity of 79.62% and a specificity of 92.76%. the candidate targets were selected according to the criteria that the possibility of interacting with potential candidate targets was higher than 0.6 for the RF model and 0.7 for the SVM model. The obtained candidate targets were finally reserved and were further predicted for their targets.

Target Validation
Molecular docking analysis was carried out using the AutoDock software (available online: http://autodock.scripps.edu/; accessed on 1 February 2012). This approach performs the docking of the small, flexible ligand to a set of grids describing the target protein. During the docking process, the protein was considered as rigid and the molecules as flexible. The crystal structures of the candidate targets were downloaded from the RCSB Protein Data Bank (available online: http://www.pdb.org/; accessed on 1 December 2011), and the proteins without crystal structures were performed based on homology modeling using the Swiss-Model Automated Protein Modelling Server (available online: http://swissmodel.expasy.org/; accessed on 1 February 2012).

TCM is a heritage that is thousands of years old and is still used by millions of people all over the world—even after the development of modern scientific medicine. Chinese herbal combinations generally include one or more plants and even animal products.

The study identified 54 protein targets, which are closely associated with CVD for the three Chinese herbs, of which 29 are common targets (52.7%), which clarifies the mechanism of efficiency of the herbs for the treatment of CVD.

Activation of NFkB

Extracellular stimuli for NFkB activation and NFkB regulated genes
Extracellular stimuli                       Regulated genes
TNFa                                         Growth factors (G/M-CSF)
Interleukin 1                            G/M CSF, M CSF, G CSF
ROS                                              Cell adhesion molecules
UV light                            ICAM-1, VCAM, E-Selectin, P-selectin
Ischaemia                                   Cytokines
Lipopolysaccharide               TNFa, IL-1, IL-2, IL-6, interferon
Bacteria                                        Transcription regulators
Viruses                                         P53, IkB, c-rel, c-myc
Amyloid                                      Antiapoptotic proteins
Glutamate                              TRAF-1, TRAF-2, c-IAP1, c-IAP2
Pathophysiology
Reactive oxygen species (ROS) are toxic and in conditions of a dysbalance between their overproduction and the diminished activity of various antioxidant enzymes and other molecules induce cellular injury termed oxidative stress. ROS are often related to a number of diseases like atherosclerosis. However, the mechanism is not clear at all. Latest years of research have brought the idea of connection between ROS and NFkB. And indeed, in vitro studies showed a rapid activation of NFkB after exposure of certain cell types to ROS. Today, no specific receptor for ROS has been found, thus, the details of the ROS induced activation of NFkB are missing.

Natural occurring agents which actions are still a matter of debate in the theory and nouvelle small molecular derivates activate or inhibit the transcriptional factor. Synthetic oligo and polypeptide inhibitors of NFkB can penetrate the cell membrane and directly act on the Rel proteins. The most sophisticated approaches towards inhibiting the activation and translocation of NFkB into the nucleus represent gene deliveries, using plasmids or adenoviruses containing genes for various super repressors—modified IkB proteins, or so called NFkB decoys, which interact with activated NFkB and thus, inhibit the interaction between the transcription factor and nuclear DNA enhancers.

A simplified scheme of the activation of NFkB by the degradation of IkB. IkB is phosphorylated by IKK and ubiquinatated by the ubiquitine ligase system (ULS). IkB is further degradated by the 26S proteasome (26S).Activated NFkB can pass the nuclear membrane and interact with kB binding sequences in enhancers of NFkB regulated genes. LPS, lipopolysaccharide; ROS, reactive oxygen species; FasL, Fas ligand; TRAF, TNFa receptor associated factor; NIK, NFkB inducing kinase; MEKK, mitogen activated protein kinase/extracellular signal regulated kinases kinases.

The medicine of this century is a medicine of molecules, the diagnostic procedure and the therapy moves further from the “clinical picture” to the use of achievements in molecular biology and genetics. However, sober scepticism and awareness are indicated. Especially the role of NFkB in multiple signal transducing pathways and the tissue dependent variability of responses to alternations in NFkB pathway may be the reasons for unwanted side effects of the therapy that are after in vitro or in vivo experiments hardly to expect in the clinical use.

Therapeutic Targets
Modern drug discovery is primarily based on the search and subsequent testing of drug candidates acting on a preselected therapeutic target. Progress in genomics, protein structure, proteomics, and disease mechanisms has led to a growing interest in an effort for finding new targets and more effective exploration of existing targets. The number of reported targets of marketed and investigational drugs has significantly increased in the past 8 years. There are 1535 targets collected in the therapeutic target database.
Knowledge of these targets is helpful for molecular dissection of the mechanism of action of drugs and for predicting features that guide new drug design and the
search for new targets. This article summarizes the progress of target exploration and investigates the characteristics of the currently explored targets to analyze their sequence, structure, family representation, pathway association, tissue distribution, and genome location features for finding clues useful for searching for new targets. Possible “rules” to guide the search for druggable proteins and the feasibility of using a statistical learning method for predicting druggable proteins directly from their sequences are discussed.

Current Trends in Exploration of Therapeutic Targets
There are 395 identifiable targets described in 1606 patents. Of these targets, 264 have been found in more than one patent and 50 appear in more than 10 patents. The number of patents associated with a target can be considered to partly correlate with the level of effort and intensity of interest currently being directed to it. Approximately one third of the patents with an identifiable target were approved in the past year. This suggests that the effort for the exploration of these targets is ongoing, and there has been steady progress in the discovery of new investigational agents directed to these targets.

Various degrees of progress have been made toward discovery and testing of agents directed at these targets. However, for some of these targets, many difficulties remain to be resolved before viable drugs can be derived. The appearance of a high number of patents associated with these targets partly reflects the intensity of efforts for finding effective drug candidates against these targets.

There are 62 targets being explored for the design of subtype-specific drugs, which represents 15.7% of the 395 identifiable targets in U.S. patents approved in 2000 through 2004. Compared with the 11 targets of FDA approved subtype-specific drugs during the same period, a significantly larger number of targets are being explored for the design of subtype-specific drugs.

What Constitutes a Therapeutic Target?
The majority of clinical drugs achieve their effect by binding to a cavity and regulating the activity, of its protein target. Specific structural and physicochemical properties, such as the “rule of five” (Lipinski et al., 2001), are required for these drugs to have sufficient levels of efficacy, bioavailability, and safety, which define target sites to which drug-like molecules can bind. In most cases, these sites exist out of functional necessity, and their structural architectures accommodate target-specific drugs that minimally interact with other functionally important but structurally similar sites.
These constraints limit the types of proteins that can be bound by drug-like molecules, leading to the introduction of the concept of druggable proteins (Hopkins and Groom, 2002; Hardy and Peet, 2004). Druggable proteins do not necessarily become therapeutic targets (Hopkins and Groom, 2002); only those that play key roles in diseases can be explored as potential targets.

 Prediction of Druggable Proteins by a Statistical Learning Method

Currently, the support vector machine (SVM) method seems to be the most accurate statistical learning method for protein predictions. SVM is based on the structural risk minimization principle from statistical learning theory. Known proteins are divided into druggable and nondruggable classes; each of these proteins is represented by their sequence-derived physicochemical features.

These features are then used by the SVM to construct a hyperplane in a higher dimensional hyperspace that maximally separates druggable proteins and nondruggable ones. By projecting the sequence of a new protein onto this hyperspace, it can be determined whether this protein is druggable from its location with respect to the hyperplane. It is a druggable protein if it is located on the side of druggable class.
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Endothelin Receptors in Cardiovascular Diseases: The Role of eNOS Stimulation
Inhibition of ET-1, ETA and ETA-ETB, Induction of NO production, stimulation of eNOS and Treatment Regime with PPAR-gamma agonists (TZD): cEPCs

Endogenous Augmentation for Cardiovascular Risk Reduction – A Bibliography

Reveals from ENCODE project will invite high synergistic collaborations to discover specific targets

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Endothelin Receptors in Cardiovascular Diseases: The Role of eNOS Stimulation 

Author and Curator of an Investigator Initiated Study: Aviva Lev-Ari, PhD, RN

A Three Component Method for Endogenous Augmentation of cEPCs

Macrovascular Disease: The  Therapeutic Potential of cEPCs

Observations on Intellectual Property Development For an Unrecognized Future Fast Acting Therapy for Patients at High Risk for Macrovascular events

ElectEagle represents a discovery of a novel “multimarker biomarker” for cardiovascular disease that innovates on four counts.

First, it proposes new therapeutic indications for acceptable drugs.

Second, it defines a specific combination of therapeutic agents, thus, it put forth a proprietary drug combination.

Third, it targets receptor systems that have not been addressed in the context of cEPCs augmentation methods. Chiefly, modulation of the following three-targeted receptor systems: (a) inhibition of ET-1, ETA and ETA-ETB receptors by antagonists (b) induction of eNOS, by agonists and NO stimulation and (c) upregulation of PPAReceptor-gamma by agonists (TZD). While (b) and (c) are implicated as having favorable effects of cEPCs count, each exerting its effect by a different pathway, it is suggested in this project that (a) might be identify to be the more powerful of the three markers. Our method, ElectEagle is the FIRST to postulate the following: (1) time concentration dependence on eNOS reuptake (2) dose concentration dependence on NO production (3) time and dose concentration dependence for ET-1, ETA and ETA-ETB inhibition, and (4) dose concentration dependence on PPAReceptor-gamma. Points First, Second and Third are covered in Part II where a special focus is placed on ET-1, ETA and ETA-ETB receptors.

Fourth, ElectEagle proposes a platform with triple modes of delivery and use of the test, as described in Part III. The triple modes are as follows: (A) an automated platform from a centralized lab with integration to Lab’s information management system. (B) a point-of-care testing device with appropriate display of test results (small benchtop analyzers in PCP office). (C) a device used for home monitoring of analytes (the hand-held device facilitates rapid read of scores and their translation to drug concentration of each of the three therapeutic agents, with computation of the three drug concentrations done by the device. Thus, it offers quicker optimization of treatment.  ElectEagle is the FIRST to propose a CVD patient kit, hand-held device, which calculates on demand an adjustable therapeutic regimen as a function of cEPCs count biomarker. In this regard, a similarity to the pump, in management of blood sugar in DM patients, exists. Since there is a high co-morbidity between DM and CVD, our methods, ElectEagle may eventually become a targeted therapy for the DM Type 2 population.

Postulates of Multiple Indications for the Method Presented: Positioning of a Therapeutic Concept for Endogenous Augmentation of cEPCs

Potential Therapeutic Indications for ElectEagle

ElectEagle can become the drug therapy of choice for the following indications:

  •       CAD patients
  •       Endothelial Dysfunction in DM patients with or without Erectile   Dysfunction
  •       Atherosclerosis patients: Arteries and or veins
  •       pre-stenting treatment phase
  •       post-stenting treatment phase
  •       if stent is a Bare Metal stent (BMS)
  •       if stent is Drug Eluting stent (DES)
  •       if stent is EPC antibody coated (the ElectEagle method increase cEPCs generation in vitro) so availability of cEPCs is increased
  •       post CABG patients (the ElectEagle enhances healing by endogenous augmentation of cEPCs)
  •       target sub segments of CVD patients on blood thinner drugs (the ElectEagle does not require treatment with antiplatelet agents, it is suitable for all patients on Coumadin. This population have a counter indication for antiplatelet agents which is a follow up treatment after stent implantation for 30 days, with stent-eluting long term regimen of antiplatelet agents, 6 months and in some cases indefinitely (Tung, 2006).
  •       ElectEagle is based on systemic therapeutics (versus the localized stent solution requiring multiple and even overlapping stents)
  •       ElectEagle will be having potential in two contexts

1.  Coronary disease

2.  Periphery vascular disease

Comparative analysis of endogenous and exogenous cEPCs augmentation methods:

A. endogenous augmentation method properties:

  •    temporal – while drug therapy in use – drug action is interruptible
  •    time concentration on eNOS reuptake
  •    dose concentration on NO production
  •    time and dose concentration manner for ETB inhibition
  •    dose concentration on PPAR-gamma

B.  cell-based and other exogenous methods

  • permanent colonization till apoptosis if no repeated attempts of re-transfer, re-implantation as the protocol usually has several stages

ElectEagle will be resulting in potential delay of stenting implantation. Patients that are target for stenting may benefit form ElectEagle that will facilitate and accelerate healing after the stent is in place. EPC antibody coated stents will work if and only if the patient has more that just low cEPCs, most patient undergoing stenting tend to have low level of cEPC. The ElectEagle method can be coupled with that type of new stents, called Genous, now in clinical trials (HEALING II, III). These stents enhance the body ability in mobilization of cEPCs, only. However, if the initial population of cEPCs is low, an endogenous fast acting cell augmentation method is needed for pretreatment before the PCI procedure with Genous is scheduled.

Mechanism of action (MOA) for ElectEagle‘s component 1

Inhibition of ET-1, ETA and ETA-ETB

Source for vasodilators substances in the endothelium are PGI2 and NO. A potent vasoconstrictor peptide is the endothelin family, first isolated in the aortic endothelial cells.

Endothelins: Biosynthesis, Structure & Clearance

Three isoforms of endothelin (ET) have been identified. ET-1, ET-2 and ET-3. Each isoform is the product of a different gene and is synthesized as a prepro form that is processed to a propeptide and then to the mature peptide. Endothelin-converting enzyme (ECE) converts a prepro into a mature peptide. Each ET is a 21-amino-acid peptide containing two disulfide bridges. ETs are widely distributed in the body. ET-1 is the predominant ET secreted by the vascular endothelium. It is also produced by neurons and astrocytes in CNS and in endometrial, renal mesangial, sertoli, breast epithelial and other cells. ETs are present in the blood in low concentrations, they act locally in a paracrine or autocrine fashion rather than as circulating hormones.

Expression of ET-1 gene is increased by Growth Factors and cytokines, transforming factor-beta (TGF-beta) and interleukin 1 (IL-1), vasoactive substances including angiotensin II and vasopressing and mechanical stress. Expression is inhibited by NO, prostacyclin and ANP (source for vasodilators substances in the endothelium are PGI2 and NO.) Clearance of ETs from the circulation is rapid and involves enzymatic degradation by NEP 24.11 and clearance by the ETB receptor.

Endothelins: Action

ET exerts many actions on the body. In particular dose-dependent vasoconstriction in most vascular beds. Intravenous administration of ET-1 causes a rapid decease in BP followed by a prolonged increase. The depressor response results PGI2 and NO release from the vascular endothelium. The pressor response is due to direct constriction of vascular smooth muscle. ETs exert direct positive inotropic and chronotropic actions on the heart and are potent coronary vasoconstrictors. ETs actions on other organ is described in (Reid, 2004). ETs interact with several endocrine systems, increase secretion of renin, aldosterone, vasopressin and Atrial natriuretic peptide (ANP.) Action exerted on CNS and PNS, GI system, liver, GU, reproductive system, eye, skeletal and skin. ET-1 is a potent mitogen for vascular smooth muscle cells, cardiac myocytes and glomerular mesangial cells.

ET receptors are present in many tissues and organs, blood vessel wall, cardiac muscle, CNS, lung, kidney, adrenal, spleen, and GI. The signal transduction mechanism triggered by binding of ET-1 to its receptors, ETA & ETB includes effects of stimulation of phospholipase C, formation of inositol triphosphate and release of calcium from the ER which results in vasoconstriction. Stimulation of PGI2 and NO synthesis result in decreased intracellular calcium concentration and vasodilation.

Two receptor subtypes, ETA & ETB have been cloned and sequenced. ETA receptors have a high affinity for ET-1 and a low affinity for ET-3 and are located on smooth muscle cells, where they mediate vasoconstriction. ETB receptors have an equal affinity for ET-1 and ET-3 and are located on vascular ECs, where they mediate release of PGI2 and NO. Both receptor types belong to the G protein-coupled seven-transmembrane domain family of receptors.

Inhibitors of Endothelin Synthesis & Action

ETs can be blocked with receptor antagonists and with drugs that block the Endothelin-converting enzyme (ECE), Endothelin-converting enzyme inhibitors (ECEI). Two receptor subtypes, ETA & ETB can be blocked selectively, or both can be blocked with nonselective ETA – ETB antagonists. Bosentan is a nonselective antagonist, available both intravenously and orally. It blocks the initial transient depressor (ETB ) and the prolonged pressor (ETA) responses to intravenous ET. Oral ET antagonists are available for research purposes. The formation of Endothelin-converting enzyme (ECE) can be blocked with Phosphoramidon. The therapeutic potential of ECEI is similar to that of the ET receptor antagonist, Bosentan, an active competitive inhibitor of ET [it has teratogenic and hepatotexic effects].

Physiologic & Pathologic Roles of Endothelin Antagonists

Systemic administration of ET receptor antagonists or ECEI causes vasodilation and decreases arterial pressure in human and in experimental animals. Intra-arterial administration of the drugs also causes slow-onset forearm vasodilation in humans. This is an evidence that the endothelin system participates in the regulation of vascular tone, even under resting conditions (Reid, 2004).

There is evidence that ETs participate in CVD, including hypertension, cardiac hypertrophy, CHF, atherosclerosis, CAD, MI. ETs have been implicated in pulmonary diseases, PA HTN, asthma, renal diseases. Increased ET levels was found in the blood, increased expression of ET mRNA in endothelial or vascular smooth muscle cells and the responses to administration of ET antagonists. ET antagonists have potential for treatment of these diseases. In clinical trials, Bosentanand other nonselective antagonists as well as ETA selective antagonists produce beneficial effects on hemodynamics and symptoms of CHF, PA HTN and essential HTN (Sütsch et al., 1998), (Haynes, 1996), (Lahav et al., 1999). Currently, it is approved for use in pulmonary hypertension (Benowitz, 2004).

ElectEagle Project Drug combination Therapy has selected Bosentan or other nonselective ET antagonists as well as ETA selective antagonists to enhance the effects an eNOS agonist and a PPAR-gamma agonist will have on CVD patient’s propensity to achieve beneficial effects for endogenous augmentation of cEPCs. The impact the ETs have on the body is of a very wide range and of a most important from a physiological point of view, respectively, we did not leave Big ET-1 out of the therapeutic treatment design.

Proposed integration plan for ElectEagle’s Version I with CVD patients current medication regimen for selective medical diagnoses

Blood Pressure Medicine:

Beta blockers, Verapamil (Calan), Reserpine (Hydropes), Clonidine (Catapres), Methyldopa (Aldomet)

Diuretics:

Thiazides, Spironolactone (Aldactone), Hydralazine

Antidepressants:

Prozac, Lithium, MOA’s, Tricyclics

Stomach Medicine:

Tagamet and Zantac, plus other compounds containing Cimetidine and Ranitidine or associated compounds in Anticholesterol Drugs

Antipsychotics:

Chlorpromazine (Thorazine), Pimozide (Orap), Thiothixine (Navane), Thiordazine (Mellaril), Sulpiride, Haloperidol (haldol), Fluphenazine (Modecate, Prolixin)

Heart Medicine:

Clofibrate (Atromid), Gemfibrozil, Diagoxin

Hormones:

Estrogen, Progesterone, Proscar, Casodex, Eulexin, Corticosteroids Gonadotropin releasing antagonists: Zoladex and Lupron

Cytotoxic agents:

Cyclophosphamide, Methotrexate, Roferon Non-steroidal anti-inflammatories

Others

Alprazolam, Amoxapine, Chlordiazepoxide, Sertraline, Paroxetine, Clomipramine, Fluvoxamine, Fluoxetine, Imipramine, Doxepine, Desipramine, Clorprothixine, Bethanidine, Naproxen, Nortriptyline, Thioridazine, Tranylcypromine, Venlafaxine, Citalopram.

INTERACTIONS for Nebivolol

Calcium Antagonists:

Caution should be exercised when administering beta-blockers with calcium antagonists of the verapamil or diltiazem type because of their negative effect on contractility and atrio-ventricular conduction. Exaggeration of these effects can occur particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities. Neither medicine should therefore be administered intravenously within 48 hours of discontinuing the other.

Anti-arrhythmics:

Caution should be exercised when administering beta-blockers with Class I anti-arrhythmic drugs and amiodarone as their effect on atrial conduction time and their negative inotropic effect may be potentiated. Such interactions can have life threatening consequences.

Clonidine:

Beta-blockers increase the risk of rebound hypertension after sudden withdrawal of chronic clonidine treatment.

Digitalis:

Digitalis glycosides associated with beta-blockers may increase atrio-ventricular conduction times. Nebivolol does not influence the kinetics of digoxin & clinical trials have not shown any evidence of an interaction.

Special note: Digitalisation of patients receiving long term beta-blocker therapy may be necessary if congestive cardiac failure is likely to develop. The combination can be considered despite the potentiation of the negative chronotropic effect of the two medicines. Careful control of dosages and of individual patient’s response (notably pulse rate) is essential in this situation.

Insulin & Oral Antidiabetic drugs:

Glucose levels are unaffected, however symptoms of hypoglycemia may be masked.

Anaesthetics:

Concomitant use of beta-blockers & anaesthetics e.g. ether, cyclopropane & trichloroethylene may attenuate reflex tachycardia & increase the risk of hypotension

Testing ElectEagle’s a-priori postulates presented in Part I

a-priori postulates presented in Part I for Component 1:ET-1, ETA and ETA-ETB inhibition

  • time and dose concentration dependence for ETA and ETA-ETB inhibition

 In the literature we found evidence for dose concentration dependence manner (Reid, 2004).

 

ETA and ETA-ETB inhibitor time concentration dependence manner dose concentration dependencemanner time and dose dose 
Bosentan   (Reid, 2004)   62.5, 125 mg tablets

a-priori postulates presented in Part I for Component 2: NO, eNOS induction and stimulation

  • time concentration dependence on eNOS reuptake
  • dose concentration dependence on NO production

In the literature we found evidence for dose concentration dependence manner

Ach, Histamine, Genistein, ACEI, Fenofibrates, NEBIVOLOL, Calcium channel blocker, Enzyme S-nitrosylation

In the literature we found evidence for time concentration dependence manner:

Ach, BRL37344, a 3-adrenoceptor agonist

In the literature we found evidence for time and dose concentration dependence manner:

Histamine

NO, eNOS AgonistsStimulate phosphorylation of eNOS at serine 1177, 1179, 116 Conversion of L-arginine toL-citrulline time concentration dependence manner dose concentration dependencemanner time and dose dose (nmol·mg

of protein-1)

Grovers et al., (2002)

A23187       (5µM)
Acetylcholine Xu et al., (2002) Sanchez et al., (2006)   (1µM)
5-Hydroxytryptamine       (1µM)
VEGF (       (20ng/ml)
Bradykinin       (1µM)
Histamine   McDuffie et al., (1999) McDuffie et al., (2000) (10µM)
genistein   Liu et al., (2004)   (1µM)
ACEI   Skidgel et al., (2006)    
Fenofibrates   Asai et al., (2006)    
BRL37344, a 3-adrenoceptor agonist Pott et al., (2005)      
NEBIVOLOLß1-selective adrenergic receptor antagonist with nitric oxide (NO)–mediation for vasodilation

 

  Ritter et al., (2006)    
Calcium channel blocker   Church and Fulton, (2006),    
Enzyme S-nitrosylation   Erwin et al., (2006)    

 

a-priori postulates presented in Part I for Component 3: PPAR-gamma

  • dose concentration dependence on PPAReceptor-gamma – confirmed by a study for Rosiglitazone and a study for Ciglitazone
PPAReceptor-gamma agonists time concentration dependence manner dose concentration dependencemanner time and dose dose 
Rosiglitazone   Polikandriotis et al., (2005)   maximum recommended daily dose of 8 mg to 2,000 mg.
Ciglitazone Polikandriotis et al., (2005)    

 

Development of an Experimental Treatment Protocol for

ElectEagle Version I

Therapeutic Strategy for cEPCs Endogenous Augmentation for measuring the number of circulating Endothelial Progenitor Cells (cEPCs) before and after a newly design treatment with Pharmacological agents

Component 1: Inhibition of ET-1, ETA and ETA-ETB

Bosentan (Tracleer) Oral: 62.5, 125 mg tablets

 

Component 2: Induction of NO production and stimulation of eNOS

Nebivolol – ß1-selective adrenergic receptor antagonist with nitric oxide (NO)– mediation for vasodilation

A single daily dose of 5 mg was appropriate, with no evident advantage at 10 mg (Van Nueten et al.,1997)

Component 3: Treatment Regime with PPAR-gamma agonists (TZD)

A Substitute for Rosiglitazone, 2-8 mg once daily

The combination drug therapy for endogenous augmentation of cEPCs in CVD patients for achievement of reduction in risk for macrovascular events is recommended to be applied for Clinical Trial Phase One in the following regimen:

Use the following combination of drugs for the following Stages

Bosentan (Tracleer), Oral: 62.5 mg tablets

Nebivolol, Oral: 5mg once daily

A substitute for Rosiglitazone, 8 mg once daily

 

Stage 1: ET-1 Antagonist Effect on eEPC

1.0 Measurement of the Baseline of number of cEPC

1.1 Administer ET-1 antagonist for 10 days

1.2 Measurement of number of cEPC after 10 days of treatment with ET-1 antagonist

Stage 2: Nitric Oxide Effect on cEPC

2.0 Measurement of number of cEPC obtained in 1.2

2.1 Administer Nitric Oxide Agonist for 10 days

2.2 Measurement of number of cEPC after 10 days of

treatment with Nitric Oxide Agonist

Stage 3: Comparison of ET-1 and NO Effects on cEPC Proliferation

3.0 Comparison of number of cEPC in 1.2 to 2.2

¨     IF number of cEPC in 1.2 > number of cEPC in 2.2

-> continue 1.1 only

[ET-1 antagonist more effective for proliferation of cEPC than NO Agonist]

3.1.1      Measurement of number of cEPC every 10 days

¨     IF number of cEPC in 1.2 < number of cEPC in 2.2

-> continue 2.1 only

[ET-1 antagonist less effective for proliferation of cEPC than NO Agonist]

3.2.1      Measurement of number of cEPC every 10 days

¨     IF number of cEPC in 1.2 = number of cEPC in 2.2

-> continue 1.1 AND 2.1

[ET-1 antagonist equal NO Agonist in effectiveness for proliferation of cEPC]

-> Administer a Combination therapy of ET-1 antagonist and NO Agonist for 10 days

3.3.1      Measurement of number of cEPC every 10 days

Stage 4: ET-1 and/or NO Effect on Cardiovascular (CV) Events

q      After 12 months Comparison of CV events in patient population in

Stage 3.1, 3.2, 3.3

  • Cardiovascular events in patients in 3.1
  • Cardiovascular events in patients in 3.2
  • Cardiovascular events in patients in 3.3

Conclusions

  •       Most favorable and unexpected to us was finding in the literature new indications for TDZs as stimulators of eNOS, in addition to the new indication for atherosclerosis besides the classic indication in pharmacology books, being in the reduction of insulin resistance. Reassuring our selection of a substitute for Rosiglitazone.
  •       Most favorable and unexpected to us was finding in the literature new indications for beta blockers as NO stimulant, nebivolol, a case in point, thus, fulfilling two indications in one drug along the direction of the study to identify eNOS agonists.
  •       The following combination of drugs was selected for ElectEagle Version I

Bosentan (Tracleer), Oral: 62.5 mg tablets

Nebivolol, Oral: 5mg once daily

A Substitute for Rosiglitazone, 8 mg once daily

  •       We confirmed time and dose concentrations postulating apriori in most cases. Additional literature searches will benefit the project for the three drugs selected
  •       We have identified Inhibition of ET-1, ETA and ETA-ETB as one of the agent in the drug combination. The entire literature on cEPCs does not implicate Endothelin with impact on eEPCs while it is known that mechanical stress increase its secretion, this type of stress is implicated with hypertension. To leave out ET-1 from the cEPCs function in CVD risk equates to leaving out Thrombin from the coagulation cascade. ElectEagle Version I corrects that ommission. 

REFERENCES

Benowitz, NL., (2004). Antihypertensive Agents. Chapter 11 in Katzung, BG., Basic & Clinical Pharmacology. McGraw-Hill, 9th Edition, pp. 160-183.

Haynes WG, Ferro CJ, O’Kane KP, Somerville D, Lomax CC, Webb DJ, (1996). Systemic endothelin receptor blockade decreases peripheral vascular resistance and blood pressure in humans. Circulation, 15;93(10):1860-70. 

N S Kirkby, P W F Hadoke, A J Bagnall, and D J Webb (2008)

The endothelin system as a therapeutic target in cardiovascular disease: great expectations or bleak house? Br J Pharmacol. 2008 March; 153(6): 1105–1119.

Ohkita Mamoru, Masashi Tawa, Kento Kitada and Yasuo Matsumura (2012). Pathophysiological Roles of Endothelin Receptors in Cardiovascular Diseases,  J Pharmacol Sci 119, 302 – 313 (2012)

Reid, Ian A., (2004). Vasoactive Peptides. Chapter 17 in Katzung, BG., Basic & Clinical Pharmacology. McGraw-Hill, 9th Edition, pp. 281 – 297, in particular, Endothelins, pp. 290-293.

  For a comprehensive Bibliography on the Three Therapeutic Componenets and the pathophysiology of Cardiovascular Disease, follow this link:

Inhibition of ET-1, ETA and ETA-ETB, Induction of NO production, stimulation of eNOS and Treatment Regime with PPAR-gamma agonists (TZD): cEPCs Endogenous Augmentation for Cardiovascular Risk Reduction – A Bibliography

http://pharmaceuticalintelligence.com/2012/10/04/inhibition-of-et-1-eta-and-eta-etb-induction-of-no-production-and-stimulation-of-enos-and-treatment-regime-with-ppar-gamma-agonists-tzd-cepcs-endogenous-augmentation-for-cardiovascular-risk-reduc/

 Other aspects of Nitric Oxide involvement in biological systems in humans are covered in the following posts on this site:

Nitric Oxide in bone metabolism July 16, 2012

Author: Aviral Vatsa PhD, MBBS

http://pharmaceuticalintelligence.com/2012/07/16/nitric-oxide-in-bone-metabolism/?goback=%2Egde_4346921_member_134751669

 

Nitric Oxide production in Systemic sclerosis July 25, 2012

Curator: Aviral Vatsa, PhD, MBBS

http://pharmaceuticalintelligence.com/2012/07/25/nitric-oxide-production-in-systemic-sclerosis/?goback=%2Egde_4346921_member_138370383

 

Nitric Oxide Signalling Pathways August 22, 2012 by

Curator/ Author: Aviral Vatsa, PhD, MBBS

http://pharmaceuticalintelligence.com/2012/08/22/nitric-oxide-signalling-pathways/?goback=%2Egde_4346921_member_151245569

 

Nitric Oxide: a short historic perspective August 5, 2012

Author/Curator: Aviral Vatsa PhD, MBBS

http://pharmaceuticalintelligence.com/2012/08/05/nitric-oxide-a-short-historic-perspective-7/

 

Nitric Oxide: Chemistry and function August 10, 2012

Curator/Author: Aviral Vatsa PhD, MBBS

http://pharmaceuticalintelligence.com/2012/08/10/nitric-oxide-chemistry-and-function/?goback=%2Egde_4346921_member_145137865

 

Nitric Oxide and Platelet Aggregation August 16, 2012 by

Author: Dr. Venkat S. Karra, Ph.D.

http://pharmaceuticalintelligence.com/2012/08/16/no-and-platelet-aggregation/?goback=%2Egde_4346921_member_147475405

 

The rationale and use of inhaled NO in Pulmonary Artery Hypertension and Right Sided Heart Failure August 20, 2012

Author: Larry Bernstein, MD

http://pharmaceuticalintelligence.com/2012/08/20/the-rationale-and-use-of-inhaled-no-in-pulmonary-artery-hypertension-and-right-sided-heart-failure/

Nitric Oxide: The Nobel Prize in Physiology or Medicine 1998 Robert F. Furchgott, Louis J. Ignarro, Ferid Murad August 16, 2012

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2012/08/16/nitric-oxide-the-nobel-prize-in-physiology-or-medicine-1998-robert-f-furchgott-louis-j-ignarro-ferid-murad/

 

Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents August 13, 2012

Author: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

 

Nano-particles as Synthetic Platelets to Stop Internal Bleeding Resulting from Trauma

August 22, 2012

Reported by: Dr. V. S. Karra, Ph.D.

http://pharmaceuticalintelligence.com/2012/08/22/nano-particles-as-synthetic-platelets-to-stop-internal-bleeding-resulting-from-trauma/

Cardiovascular Disease (CVD) and the Role of agent alternatives in endothelial Nitric Oxide Synthase (eNOS) Activation and Nitric Oxide Production July 19, 2012

Curator and Research Study Originator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2012/07/19/cardiovascular-disease-cvd-and-the-role-of-agent-alternatives-in-endothelial-nitric-oxide-synthase-enos-activation-and-nitric-oxide-production/

Macrovascular Disease – Therapeutic Potential of cEPCs: Reduction Methods for CV Risk

July 2, 2012

An Investigation of the Potential of circulating Endothelial Progenitor Cells (cEPCs) as a Therapeutic Target for Pharmacological Therapy Design for Cardiovascular Risk Reduction: A New Multimarker Biomarker Discovery

Curator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2012/07/02/macrovascular-disease-therapeutic-potential-of-cepcs-reduction-methods-for-cv-risk/

 

Bone remodelling in a nutshell June 22, 2012

Author: Aviral Vatsa, Ph.D., MBBS

http://pharmaceuticalintelligence.com/2012/06/22/bone-remodelling-in-a-nutshell/

Targeted delivery of therapeutics to bone and connective tissues: current status and challenges- Part, September  

AuthorL Aviral Vatsa, PhD, September 23, 2012

http://pharmaceuticalintelligence.com/2012/09/23/targeted-delivery-of-therapeutics-to-bone-and-connective-tissues-current-status-and-challenges-part-i/

Calcium dependent NOS induction by sex hormones: Estrogen

Curator: S. Saha, PhD, October 3, 2012

http://pharmaceuticalintelligence.com/2012/10/03/calcium-dependent-nos-induction-by-sex-hormones/

 

Nitric Oxide and Platelet Aggregation,

Author V. Karra, PhD, August 16, 2012

http://pharmaceuticalintelligence.com/2012/08/16/no-and-platelet-aggregation/

Bystolic’s generic Nebivolol – positive effect on circulating Endothelial Progenitor Cells endogenous augmentation

Curator: Aviva Lev-Ari, PhD, July 16, 2012

http://pharmaceuticalintelligence.com/?s=Nebivolol

 

Endothelin Receptors in Cardiovascular Diseases: The Role of eNOS Stimulation

Author: Aviva Lev-Ari, PhD, 10/4/2012

http://pharmaceuticalintelligence.com/2012/10/04/endothelin-receptors-in-cardiovascular-diseases-the-role-of-enos-stimulation/

 

Inhibition of ET-1, ETA and ETA-ETB, Induction of NO production, stimulation of eNOS and Treatment Regime with PPAR-gamma agonists (TZD): cEPCs Endogenous Augmentation for Cardiovascular Risk Reduction – A Bibliography

Curator: Aviva Lev-Ari, 10/4/2012.

http://pharmaceuticalintelligence.com/2012/10/04/inhibition-of-et-1-eta-and-eta-etb-induction-of-no-production-and-stimulation-of-enos-and-treatment-regime-with-ppar-gamma-agonists-tzd-cepcs-endogenous-augmentation-for-cardiovascular-risk-reduc/

 

Nitric Oxide Nutritional remedies for hypertension and atherosclerosis. It’s 12 am: do you know where your electrons are?

Author and Reporter: Meg Baker, 10/7/2012.

http://pharmaceuticalintelligence.com/2012/10/07/no-nutritional-remedies-for-hypertension-and-atherosclerosis-its-12-am-do-you-know-where-your-electrons-are/

Drug Information

Component 1: Inhibition of ET-1, ETA and ETA-ETB

Bosentan (Tracleer)

BACKGROUND: Although local inhibition of the generation or actions of endothelin-1 has been shown to cause forearm vasodilatation, the systemic effects of endothelin receptor blockade in healthy humans are unknown. We therefore investigated the cardiovascular effects of a potent peptide endothelin ETA/B receptor antagonist, TAK-044, in healthy men. METHODS AND RESULTS: Two randomized, placebo-controlled, crossover studies were performed. In nine subjects, TAK-044 (10 to 1000 mg IV over a 15-minute period) caused sustained dose-dependent peripheral vasodilatation and hypotension. Four hours after infusion of the highest dose (1000 mg), there were decreases in mean arterial pressure of 18 mm Hg and total peripheral resistance of 665 AU and increases in heart rate of 8 bpm and cardiac index of 0.9 L x min(-1) x m(-2) compared with placebo. TAK-044 caused a rapid, dose-dependent increase in plasma immunoreactive endothelin (from 3.3 to 35.7 pg/mL within 30 minutes after 1000 mg). In a second study in eight subjects, intravenous administration of TAK-044 at doses of 30, 250, and 750 mg also caused peripheral vasodilatation, and all three doses abolished local forearm vasoconstriction to brachial artery infusion of endothelin-1. Brachial artery infusion of TAK-044 caused local forearm vasodilation. CONCLUSIONS: The endothelin ETA/B receptor antagonist TAK-044 decreases peripheral vascular resistance and, to a lesser extent, blood pressure; increases circulating endothelin concentrations; and blocks forearm vasoconstriction to exogenous endothelin-1. These results suggest that endogenous generation of endothelin-1 plays a fundamental physiological role in maintenance of peripheral vascular tone and blood pressure. The vasodilator properties of endothelin receptor antagonists may prove valuable therapeutically (Haynes et al., 1996).

http://www.tracleer-pph.com/

http://www.medicinenet.com/script/main/art.asp?articlekey=44221&pf=3&page=1

GENERIC NAME: BOSENTAN – ORAL (boh-SEN-tan)

BRAND NAME(S): Tracleer

WARNING: This medication may cause serious liver problems. Your doctor should monitor your liver function closely to decrease your risk of liver-related side effects. Tell your doctor immediately if you notice any of these symptoms of liver problems: nausea, vomiting, stomach pain, unusual tiredness, and yellowing eyes or skin. These effects, if they occur, may go away over time (are reversible). This medication must not be used during pregnancy because it can cause fetal harm (e.g., birth defects). See the pregnancy warning information below (in Precautions section).

USES: Bosentan is used to treat a condition of high blood pressure in the lungs (pulmonary arterial hypertension). It works by causing the blood vessels (arteries) in the lungs to relax and expand, thus decreasing the pressure.

HOW TO USE: Before using, review the bosentan Medication Guide for information on the safe use of this medicine. Take this medication by mouth usually twice daily in the morning and evening with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Your doctor may recommend to gradually increase your dose over time so your body may better adjust to the effects of this drug. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

SIDE EFFECTS: Headache, nose/throat irritation, itching, flushing, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, unusual tiredness and weakness, swelling of the feet or ankles, trouble breathing, dizziness or lightheadedness. If you notice any of the following very serious side effects of liver problems, stop taking bosentan and consult your doctor immediately: vomiting, stomach pain, yellowing eyes or skin. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, severe trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: liver problems, blood disorders (e.g., anemia), any allergies. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication must not be used during pregnancy because it may cause fetal harm. If you are pregnant or think you may be pregnant, do not take this medication and consult your doctor immediately. It is recommended that you use two reliable forms of birth control while taking this medicine. It is also recommended to have a pregnancy test done before treatment and every month during treatment with this drug. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.

DRUG INTERACTIONS: This drug is not recommended for use with: cyclosporine, glyburide. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: azole antifungals (e.g., itraconazole, ketoconazole), statins for high cholesterol (e.g., lovastatin, simvastatin), HIV protease inhibitors (e.g., indinavir, ritonavir), tacrolimus. This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function tests- LFT’s, blood tests) will be performed to monitor your progress and for side effects.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507

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Curated/reported by : Aviral Vatsa PhD, MBBS

Based on : S Moncada et al

It was in 1980 that Furchgott & Zawadzki first described endothelium- dependent relaxation of the blood vessels by acetylcholine. Further studies in 1984 revealed that other factors such as bradykinin, histamine and 5-hydroxytryptamine release endothelium derived relaxing factor (EDRF), which can modulate vessel tone. EDRF was shown to stimulate soluble guanylate cyclase and was inhibited by haemoglobin. In 1986 it was demonstrated that superoxide (O2–) anions mediated EDRF inactivation and that the inhibitors of EDRF generated superoxide (O2–) anions in solution as a mean to inhibit EDRF. It was later established that all compounds that inhibit EDRF have one property in common, redox activity, which accounted for their inhibitory action on EDRF. One exception was haemoglobin, which inactivates EDRF by binding to it. In 1987 Furchgott proposed that EDRF might be nitric oxide (NO) based on a study of the transient relaxations of endothelium-denuded rings of rabbit aorta to ‘acidified’ inorganic nitrite (NO–) solutions and the observations that superoxide dismutase (SOD, which removes O2–) protected EDRF. Till then NO was not known to be produced in mammalian cells. In 1988 Palmer et al could detect NO production both biologically and chemically by chemiluminescence. The following year in 1989 the enzyme responsible for NO production, NO synthase, was discovered and L-arginine:NO pathway was proposed.

Roles of L-arginine:NO pathway

By 1987 it was proposed that NO is generated in tissues other than endothelium. Hibbs et al and Marletta et al proposed that NO was generated by macrophages. Moreover release of EDRF was demonstrated in cerebellar cells following activation with N-methyl-D- aspartate (NMDA ). Both noradrenergic and cholinergic responses are ‘controlled’ by the nitrergic system so that the release of NO (e.g., during electrical field stimulation) counteracts and dominates the response to the noradrenergic or cholinergic stimulus (Cellek & Moncada, 1997). Mechanism of penile erection was unveiled by the studies on nitrergic neurotransmission that led to therapeutic intervention. Selective damage of nitrergic nerves in disease states was proposed as a potent mechanism of pathophysiology. Broadly three areas of research based on three isoforms of NOS came into being;

  • cardiovascular
  • nervous
  • immunology

Identification of NG-monomethyl-L-arginine (L-NMMA) as an inhibitor of the synthesis of NO lay the basis of future research into investigating the role of NO in biological systems. In 1989 it was demonstrated that intravenous infusion of L-NMMA resulted in increase in blood pressure that was reversible by infusing L-arginine. NO was thus implicated in constantly maintaining blood vessel tone. eNOS knockout studies showed a hypertensive phenotypes in the animal models and over expression of eNOS led to lowering of the blood pressure. Furthermore, eNOS activation was attributed to phosphorylation of a specific tyrosine residue in the enzyme.

NO and Mitochondria 

http://pharmaceuticalintelligence.com/2012/09/16/nitric-oxide-has-a-ubiquitous-role-in-the-regulation-of-glycolysis-with-a-concomitant-influence-on-mitochondrial-function/

NO reacts with some of the complexes of the respiratory chain, and inhibits mitochondrial respiration – this is a well accepted notion. Initially it was believed that the target for NO was soluble guanylate cyclase, which in vasculature would lead to elevation of cGMP that eventually results in NO mediated vasodilatation and platelet aggregation inhibition. In 1994, another potential target, cytochrome c oxidase, for inhibitory effects of NO was discovered. This was a reversible effect, in competition with oxygen concentrations. Increases in NO production were also shown to inhibit cellular respiration irreversibly by selectively inhibiting complex I . Hence in 2002 it was proposed that this might be a mechanism through which cell pathology was initiated in certain conditions. Furthermore, NO was proposed to be implicated in the activation of the grp78-dependent stress response , via modulating calcium-related interaction between mitochondria and endoplasmic reticulum . This host defence mechanism might also have role in vasculature. Further evidence was provided in 2003 to link the role of NO in mitochondrogenesis and thus indicating that NO might be involved in the regulation of the balance between glycolysis and oxidative phosphorylation in cells.

NO and Pathophysiology

Lack of NO: By 2000, NO was established as a haemostatic regulator in the vasculature. Its absence was implicated in pathological states such as hypertension and vasospasm. These pathophysiological states share a common beginning of endothelial dysfunction, which has low NO production as one of its characterstic features. This dysfunction has been observed prior to the appearance of cardiovascular disease in predisposed subjects with family history of essential hypertension and atherosclerosis. The most likely mechanism for endothelial dysfunction is that of a reduced bioavailability of NO . The mechanism of this aspect is discussed elsewhere on this site. Protection against reduction of NO bio-availability in the vasculature is a vital therapeutic target and is extensively explored. This can be achieved by the use of antioxidants and/or augmentation of eNOS expression. In 2003 statins were shown to increase the production of endothelial NO in endothelial cell cultures and in animals by the reduction of oxidative stress or by increasing the coupling of the eNOS. It was way back in 1994 that oestrogen was shown to increase both the activity and expression of eNOS. In addition, more recently in 2003, oestrogen was shown to reduce the breakdown of available NO.

Excess of NO: In 2000 it was shown that NO produced from iNOS in vasculature is involved in extensive vasodilatation in septic shock. Later it was demonstrated that inhibition of mitochondrial respiration is an important component of the NO-induced tissue damage. This inhibition of respiration, which is initially NO-dependent and reversible, becomes persistent with time as a result of oxidative stress . Such metabolic hypoxic states where in tissues cannot utilise available oxygen due to NO, could also contribute to other inflammatory and degenerative conditions. An obvious therapeutic target for reducing NO production in such conditions would be L-NMMA. L-NMM was tested in a clinical trial for septic shock in 2004. The results were however disappointing probably due to the blanket reduction in NO production from other NOS enzymes there by having deleterious effects on the treatment group. More specific inhibitors for NOS forms are being investigated for in different disease states.

In conclusion, the L-arginine: NO pathway has had a major impact in many areas of research, specially vascular biology. A lot has been understood about this pathway and its interactions, therapeutic targets are being aggressively investigated, but further investigations are required to delineate further the role of NO in human health and disease.

Further Reading

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1760731/?tool=pubmed

Nitric Oxide and Platelet Aggregation

Inhaled NO in Pulmonary Artery Hypertension and Right Sided Heart Failure

Cardiovascular Disease (CVD) and the Role of agent alternatives in endothelial Nitric Oxide Synthase (eNOS) Activation and Nitric Oxide Production

Nitric Oxide in bone metabolism

Nitric oxide and signalling pathways

Rationale of NO use in hypertension and heart failure

Interaction of Nitric Oxide and Prostacyclin in Vascular Endothelium

Nitric Oxide has a ubiquitous role in the regulation of glycolysis -with a concomitant influence on mitochondrial function

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Interaction of Nitric Oxide and Prostacyclin in Vascular Endothelium

Author: Larry H. Bernstein, MD

 

This review identifies the complex interactions and underlying regulatory balances/imbalances between the mechanism of vasorelaxation and vasoconstriction of vascular endothelium by way of nitric oxide (NO), prostacyclin, in response to oxidative stress and intimal injury.

A series of related topics have been covered in this Scientific Web Site: http://pharmaceuticalintelligence.com on the Nitric Oxide series:
Nitric oxide: role in Cardiovascular health and disease
The rationale and use of inhaled NO in Pulmonary Artery Hypertension and Right Sided Heart Failure

Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

Intravascular Stimulation of Autonomics: A Letter from Dr. Michael Scherlag

Will these findings impact the Clopidogrel market?

Positioning a Therapeutic Concept for Endogenous Augmentation of cEPCs — Therapeutic Indications for Macrovascular Disease: Coronary, Cerebrovascular and Peripheral

Cardiovascular Outcomes: Function of circulating Endothelial Progenitor Cells (cEPCs): Exploring Pharmaco-therapy targeted at Endogenous Augmentation of cEPCs

Endothelial Dysfunction, Diminished Availability of cEPCs, Increasing CVD Risk for Macrovascular Disease – Therapeutic Potential of cEPCs

Outcomes in High Cardiovascular Risk Patients: Prasugrel (Effient) vs. Clopidogrel (Plavix); Aliskiren (Tekturna) added to ACE or added to ARB

Vascular Medicine and Biology: CLASSIFICATION OF FAST ACTING THERAPY FOR PATIENTS AT HIGH RISK FOR MACROVASCULAR EVENTS Macrovascular Disease – Therapeutic Potential of cEPCs

Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report

Nitric Oxide Signalling Pathways

Age-Dependent Depression in Circulating Endothelial Progenitor Cells in Coronary Artery Bypass Grafting Patients

Nitric Oxide: The Nobel Prize in Physiology or Medicine 1998 Robert F. Furchgott, Louis J. Ignarro, Ferid Murad

Nitric Oxide and Platelet Aggregation

Obstructive coronary artery disease diagnosed by RNA levels of 23 genes – CardioDx heart disease test wins Medicare coverage

Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Nitric Oxide: Chemistry and function

Nitric Oxide: a short historic perspective

Human Embryonic-Derived Cardiac Progenitor Cells for Myocardial Repair

Nitric Oxide production in Systemic sclerosis

Cardiovascular Disease (CVD) and the Role of agent alternatives in endothelial Nitric Oxide Synthase (eNOS) Activation and Nitric Oxide Production

Endothelial Differentiation and Morphogenesis of Cardiac Precursors

Bystolic’s generic Nebivolol – positive effect on circulating Endothelial Progenitor Cells endogenous augmentation

Nitric Oxide in bone metabolism

Circulating Endothelial Progenitor Cells Milestones in the research on Circulating Endothelial Progenitor Cells as diagnostic markers of cardiovascular risk have been reported in NEJM

Transcription Factor Lyl-1 Critical in Producing Early T-Cell Progenitors

Macrovascular Disease – Therapeutic Potential of cEPCs: Reduction Methods for CV Risk

Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes

Study Finds Low Methylation Regions Prone to Structural Mutation

Atherosclerosis, studied extensively, has common features in the aorta, coronary, carotid and peripheral arteries. There is commonality in morphology of atheromatous plaques, the degree of thrombus formation and types of ensuing ischemic events, therefore, plaque disruption, the degree of thrombus formation and types of ensuing ischemic coronary syndromes of patients have been extensively studied. A concept of unstable atherosclerotic plaques that are amenable to rupture is central to acute myocardial infarction, stroke, aortic aneurysm and sequellae, and peripheral artery disease. These unstable atherosclerotic plaques: plaques with an unstable morphology are essential to the onset of unstable coronary artery disease. Plaque formation results from complex cellular interactions in the intima of arteries, which take place between resident cells of the vessel wall (smooth muscle cells and endothelial cells) and cells of the immune system (leukocytes). Local flow disturbances, extracellular matrix composed of lipids and debris are defining characteristics of the ‘atheroma’.
Inflammation and repair are key events in the natural course of atherosclerosis, and inflammatory cells have profound effects on the integrity of the plaques . Smooth muscle cells produce by far most of the extracellular matrix components of a plaque. Transforming growth factor beta (TGF-β) is one of the most potent stimulators of connective tissue production by smooth muscle cells, and large amounts of this growth factor are detected in restenosis lesions after PTCA.
Atherosclerotic plaque rupture – pathologic basis of plaque stability and instability. AC Newby, P Libby, and AC. van der Wal. Cardiovasc Res 1999; 41 (2): 334-344. doi: 10.1016/S0008-6363(98)00276-4. Vascular endothelium acts as a paracrine/endocrine organ by secreting a wide range of biologically active mediators that play a key role in regulating immune responses, vascular tone and coagulation, and act on adjacent smooth muscle cells, monocytes, macrophages, fibroblasts and organ specific cells.

The key culprits include:

VASODILITATION

  • vasodilators (prostacycline (PGI2),
  • nitric oxide (NO),
  • endothelium-derived relaxing factor (EDRF) ) and
  • cardiac specific natriuretic peptides;

The chemical nature of EDRF was not known until Palmer, Ferrige and Moncada demonstrated that nitric oxide accounted for most if not all of the biological activity of EDRF. Both EDRF and NO act through the stimulation of soluble guanylate cyclase and subsequent formation of cyclic GMP (cGMP). Cyclic GMP activates cGMP-dependent protein kinases and leads to dephosphorylation of myosin light chains and muscle relaxation.

Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature 1987; 327:524-6.

Waldman SA, Murad F. Cyclic GMP synthesis and function. Pharma Rev 1987; 39:163-96.

Gryglewski RJ, Botting RM, Vane JR. Mediators produced by the endothelial cell. Hypertension 1988; 12:530-48.

VASOCONSTRICTION

  • vasoconstrictors (endothelin-1 (ET), thromboxane A2, prostaglandin H2 and components of renin-angiotensin system);
  • pro- and anti-thrombotic factors (tissue factor, platelet activating factor (PAF), von Willebrand factor (vWf ) );
  • fibrinolytic activators and inhibitors (tissue plasminogen activator (t-PA), plasminogen activator inhibitor-1 (PAI-1));
  • arachidonate metabolites (prostanoids)( Prostanoids are cyclic lipid mediators which arise from enzymic cyclooxygenation of linear polyunsaturated fatty acids, e.g. arachidonic acid (20:4 n 6, AA). Biologically active prostanoids deriving from AA include stable prostaglandins (PGs), e.g. PGE(2), PGF(2alpha), PGD(2), PGJ(2) as well as labile prostanoids, i.e. PG endoperoxides (PGG(2), PGH(2)), thromboxane A(2) (TXA(2)) and prostacyclin (PGI(2)). Stable PGs regulate smooth muscle tone and also modulate inflammatory and immune reactions in this context. PG endoperoxides are intermediates in biosynthesis of all prostanoids. Gryglewski RJ. Prostacyclin among prostanoids. Pharmacol Rep. 2008 Jan-Feb;60(1):3-11.
  • leukocyte adhesion molecules (intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), E-selectin, P-selectin);
  • multiple cytokines transforming growth factor, proinflammatory and anti-inflammatory mediators, tumour necrosis factor, chemokines and steroids.
  • HU Rehman. Vascular Endothelium as an Endocrine Organ. Proc R Coll Physicians Edinb 2001; 31:149-154.

Prostanoids are cyclic lipid mediators which arise from enzymic cyclooxygenation of linear polyunsaturated fatty acids (n-6 PUFAs), e.g. arachidonic acid (20:4 n 6, AA). Labile Thromboxane A(2) (TXA(2)) ( half life of 30 s at 37 degrees C), generated by platelets has powerful vasoconstrictor, cytotoxic and thrombogenic properties.

Prostacyclin (PGI(2)) with a half life of 4 min at 37 degrees C  is produced by the vascular wall (predominantly by the endothelium) and is a physiological antagonist of TXA(2), and is a powerful cytoprotective agent that exerts its action through activation of adenylate cyclase. PGI(2) acts in concert with the system consisting of NO synthase (eNOS)/nitric oxide free radical (NO)/guanylate cyclase/cyclic-GMP. Both cyclic nucleotides (c-AMP and c-GMP) act in synergy as two energetic fists which defend the cellular machinery from being destroyed by endogenous or exogenous aggressors.

Recently, a new partner has been recognized in this endogenous defensive squadron, i.e. a system involving heme oxygenase (HO-1) and carbon monoxide (CO). The expanding knowledge on the pharmacological steering of this enzymic triad (PGI(2)-S/eNOS/HO-1) is likely to contribute to the rational therapy of many systemic diseases such as

  • atherosclerosis,
  • diabetes mellitus,
  • arterial hypertension or
  • Alzheimer diseases.

The discovery of prostacyclin broadened our pathophysiological horizon, and by itself opened new therapeutic possibilities.Gryglewski RJ. Prostacyclin among prostanoids. Pharmacol Rep. 2008 Jan-Feb;60(1):3-11.

Circulating and tissue endothelin immunoreactivity correlate with the severity of atherosclerosis. In patients presenting with stable and unstable angina, circulating endothelin concentrations are elevated in the setting of acute myocardial infarction. Plasma endothelin concentrations are also elevated in patients with moderate to severe congestive heart failure and correlate with the severity of the symptoms.

The vasculature of the kidney is about ten times more sensitive than that of other organs to the vasoconstrictor effects of ET-1. Endothelin affects several aspects of renal function, including

  • vasoconstriction,
  • regulation of tubule function,
  • cellular proliferation and
  • matrix production.

Endothelin is also involved in the pathogenesis of glomerulosclerosis.
Komuro I, Kurihara H, Sugiyama T et al. Endothelin stimulates c-fos and c-myc expression and proliferation of vascular smooth muscle cells. FEBS Lett 1988; 238:249-52. Miyauchi T, Yanagisawa M, Tomizawa T et al. Increased plasma concentrations of endothelin-1 and big endothelin-1 in acute myocardial infarction. Lancet 1989; 2(8653):53-4.

Physical or chemical damage to the cell membrane results in the release of prostacyclin. Other stimulators of prostacyclin release are

  • bradykinin,
  • thrombin,
  • serotonin,
  • platelet-derived growth factor (PDGF),
  • interleukin-1 and
  • adenine nucleotides.

Prostacyclin acts in a paracrine manner, on the abluminal side causing relaxation of the underlying smooth muscle and in the lumen, preventing platelets clumping onto the endothelium. Vasodilator and anti-platelet actions of prostacyclin are mediated by an increase in the concentrations of cyclic adenosine monophosphate (AMP) in smooth muscle cells and platelets. Aspirin and similar substances prevent prostacyclin formation, but have little effect on normal blood pressure.

This discussion has outlined how the vascular system establishes a tight regulation over the production of these endothelium derived vasoactive factors. Its loss allows local or generalized modifications of the vascular tone. This dysregulation is involved in the pathogenesis of

  • hypertension,
  • atherosclerosis,
  • diabetes mellitus and
  • other vasospastic disorders.

HU Rehman. Vascular Endothelium as an Endocrine Organ. Proc R Coll Physicians Edinb 2001; 31:149-154.

Epicrisis

This discussiion is at the limit of comprehension in one sitting. There is much investigation into the complex issue involving interacting biological regulatory pthaways that intersect among major disease categories, which makes targeting of therapies better, but also limited in the ability to achieve meaningful success. That is a topic for further discussion.

I can say with confidence that the story here is incomplete. The final effective solution will require that we tie together the legs of a three legged stool.

The first leg is genomic, which has not reaped as much benefit as we would like, but the successes generate epectations of better.

The second stool is in the opposing balance of nucleotides involved with vascular tone, such as GMP and the action of prostacyclins.

The third led is off the ledger, but will be developed in detail. This involves the essential role of sulfur, in H2S and in the methylation process, in the interpretation of homocysteine levels in the circulation, in the action of Acetyl CoA, S-adenosyl methionine, and GSH, which requires a knowledge of palnt and protein sources of sulfur amino acids, and variable soil conditions.

There also needs to be an understanding of commonalites between

  • infection,
  • metabolic syndrome,
  • immune-mediated inflammatory disease,
  • HIV wasting, and
  • cancer cachexia as importantly as their separatory features.

There are a few more resources to finish the discussion of NO and prostacyclin. Atherogenesis leads to decreased bioactivity of NO and this, in turn, can precipitate enhanced cell adhesion, proliferation, vasoconstriction and accelerate the generation of atherosclerotic lesions.

It is possible that some of the detrimental effects of atherosclerosis on the NO pathway result from the generation of secondary oxidants such as peroxynitrite, a product of the reaction of NO with superoxide. The pharmacologic strategies including

  • the stimulation of generation of endogenous NO,
  • NO-replacement therapy and
  • decreasing oxidative stress may be useful for ameliorating the clinical course of atherosclerosis.

MW Radomski, E Salas. Nitric oxide— biological mediator, modulator and factor of injury: its role in the pathogenesis of atherosclerosis.Atherosclerosis 1995; 118: S69–S80. (Supplement) http://dx.doi.org/10.1016/0021-9150(95)90075-6,

  • The interactions between endothelium-derived nitric oxide (NO) and prostacyclin as inhibitors of platelet aggregation were examined.
  • Porcine aortic endothelial cells released NO in quantities sufficient to account for the inhibition of platelet aggregation
  • small amounts of prostacyclin and EDRF which synergistically inhibited platelet aggregation.
  • A reciprocal potentiation of both the anti- and the disaggregating activity was also observed between low concentrations of prostacyclin and authentic NO or EDRF released from endothelial cells.
  • It is likely that interactions between prostacyclin and NO released by the endothelium play a role in the homeostatic regulation of platelet-vessel wall interactions.

MW Radomski, RMJ Palmer & S Moncada. The anti-aggregating properties of vascular endothelium: interactions between prostacyclin and nitric oxide.  Br. J. Pharmac (1987), 92, 639-646.

The activity of guanylate cyclase is altered to a much larger degree than adenylate cyclase, while cyclic nucleotide phosphodiesterase activity remains unchanged. During the early phases of thrombin- and ADP-induced platelet aggregation a marked activation of the guanylate cyclase occurs whereas aggregation induced by arachidonic acid or epinephrine results in a rapid diminution of this activity.
AJ Barbera. Cyclic nucleotides and platelet aggregation effect of aggregating agents on the activity of cyclic nucleotide-metabolizing enzymes. Biochimica et Biophysica Acta (BBA) – General Subjects 1976; 444(2):579–595.
http://dx.doi.org/10.1016/0304-4165(76)90402-5,

  • We examined the effect of endothelin-1 (ET-1) on basal and isoprenaline-enhanced L-type Ca2P current (ICaL) in guinea-pig ventricular myocytes under nystatin-perforated patch configuration.
  • ET-1 at concentrations of 5 nm had little effect on basal ICa,L, but Ica,L was enhanced by isoprenaline (500 nM) and was significantly attenuated by 5 nm ET-1 by more than 50 %. This effect was reversed upon washout. ICaL enhanced by forskolin was also decreased by ET-1.
  • The inhibitory effect of ET-1 against isoprenaline was completely blocked by the ETA receptor antagonist BQ-123 (1 /LM).
  • Although ET-1 has been shown to activate specific protein kinase C (PKC) isoforms, a significant inhibitory effect of ET-1 was maintained in the presence of the PKC inhibitor bisindolylmaleimide (20 nM). The nitric oxide (NO) donor SIN-1 (10 AM) attenuated but failed to prevent the ET- 1 effect.
  • In summary, our results demonstrate that ET-1 has no effects on basal ica,L. However, it exerts a potent inhibitory effect against isoprenaline-enhanced Ica,L. This effect is mediated through ETA receptors coupled to PTX-sensitive G-proteins and occurs in the presence of PKC inhibition and NO generation.

GP Thomas, SM Sims, M Karmazyn. Differential effects of endothelin- 1 on basal and isoprenaline-enhanced Ca2+ current in guinea-pig ventricular myocytes.  Journal of Physiology 1997;503(1):55-65

(L-arginine methyl ester) L-NAME-sensitive component of endothelium-dependent relaxation was investigated in the preconstricted femoral arteries during isometric conditions as a difference between acetylcholine-induced relaxation before and after acute NG-nitro-L-arginine methyl ester pre-treatment (L-NAME, 10-5 mol/l). Acetylcholine induced vasorelaxation of SHR was significantly greater than that in control WKY. There was a significant positive correlation between BP and L-NAME-sensitive component of relaxation of the femoral artery. There si absence of endothelial dysfunction in the femoral artery of adult borderline and spontaneously hypertensive rats and gradual elevation of L-NAME-sensitive component of vasorelaxation with increasing blood pressure.

A Puzserovap, Z Csizmadiova, I Bernatova. Effect of Blood Pressure on L-NAME-sensitive Component of Vasorelaxation in Adult Rats.  Physiol. Res. 2007:56 (Suppl. 2): S77-S84.

This review concerns the role of nitric oxide (NO) in the pathogenesis of different models of experimental hypertension (NO-deficient, genetic, salt-dependent), which are characterized by a wide range of etiology. Although the contribution of NO may vary between different models of hypertension, a unifying characteristic of these models is the presence of oxidative stress that participates in the maintenance of elevated arterial pressure and seems to be a common denominator underlying endothelial dysfunction in various forms of experimental hypertension. Besides the imbalance between the endothelial production of vasorelaxing and vasoconstricting compounds as well as the relative insufficiency of vasodilator systems to compensate augmented vasoconstrictor systems, there were found numerous structural and functional abnormalities in blood vessels and heart of hypertensive animals.

J Torok. Participation of Nitric Oxide in Different Models of Experimental Hypertension. Physiol. Res. 2008; 57: 813-825.

Cardiac NO–sGC-cGMP signaling blunts cardiac stress responses, including pressure overload–induced hypertrophy. The latter itself depresses signaling through this pathway by reducing NO generation and enhancing cGMP hydrolysis. Pressure overload depresses NO/heme-dependent sGC activation in the heart, consistent with enhanced oxidation. The data reveal a novel additional mechanism for reduced NO-coupled sGC activity related to dynamic shifts in membrane microdomain localization, with Cav3-microdomains protecting sGC from heme-oxidation and facilitating NO responsiveness. Translocation of sGC out of this domain favors sGC oxidation and contributes to depressed NO-stimulated sGC activity.

EJ Tsai, Y Liu, N Koitabashi, D Bedja, et al. Pressure-Overload–Induced Subcellular
Relocalization/Oxidation of Soluble Guanylyl Cyclase in the Heart Modulates Enzyme Stimulation. Circ Res. 2012;110:295-303.

From the studies in several laboratories, we suggest the following mechanisms for the possible regulation of guanylate cyclase activity:

  • factors that could alter the apparent cooperative nature of the enzyme,
  • interactions of metal ions with the substrate or enzyme,
  • factors that could overcome inhibition by ATP,
  • mechanisms that could regulate the interconversion of latent and active forms of the enzyme,
  • possible translocation of particulate and soluble forms of the enzyme, and
  • induction or repression of the enzyme.

H Kimura, F Murada. Two forms of guanylate cyclase in mammalian tissues and possible mechanisms for their regulation. Metabolism 1975; 24(3): 439–445.

 

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Authour/Curator: Aviral Vatsa PhD MBBS

This post is in continuation with posts on basics of NO metabolism and its effect on physiology. Other topics are covered under the following posts.

  1. Nitric Oxide and Platelet Aggregation

  2. Inhaled NO in Pulmonary Artery Hypertension and Right Sided Heart Failure

  3. Cardiovascular Disease (CVD) and the Role of agent alternatives in endothelial Nitric Oxide Synthase (eNOS) Activation and Nitric Oxide Production

  4. Nitric Oxide in bone metabolism

  5. Nitric oxide and signalling pathways

  6. Rationale of NO use in hypertension and heart failure

Nitric oxide plays wide variety of roles in cardiovascular system and acts as a central point for signal transduction pathway in endothelium. NO modulates vascular tone, fibrinolysis, blood pressure and proliferation of vascular smooth muscles. In cardiovascular system disruption of NO pathways or alterations in NO production can result in preponderance to hypertension, hypercholesterolemia, diabetes mellitus, atherosclerosis and thrombosis. The three enzyme isoforms of NO synthase family are responsible for generating NO in different tissues under various circumstances. The endothelial NOS (eNOS) is expressed in endothelial cells, the inducible NOS (iNOS) is expressed in macrophages and neuronal NOS (nNOS) is expressed in certain neurons and skeletal muscle. Although the basic mechanism of action for NO production is the same for all three NOS isoforms, yet deficiencies of each one of them manifest differently or with varying severity in the body e.g. eNOS deficiency might lead to hypertension, more severe form of vascular injury to cerebral ischaemia and more severe form of atherosclerosis induced by hypercholesterolemic diet whereas nNOS deficiency might show less severe form of vascular injury to cerebral ischaemia and absence of iNOS might lead to reduced hypotension in septic shock.

Reduction in NO production is implicated as one of the initial factors in initiating endothelial dysfunction. This reduction could be due to

  • reduction in eNOS production

  • reduction in eNOS enzymatic activity

  • reduced bioavailability of NO

eNOS production is increased by physiological sheer stress on endothelial cells resulting from normal flow of blood along the arterial walls. Alterations in fluid sheer stress patterns e.g due to arterial constriction has been shown to have detrimental effect on eNOS production in endothelial cells. eNOS production is decreased by LDL, angiotensin II and TNF alpha. eNOS is tightly coupled enzyme and its activity can be significantly reduced by reduction in availability of cofactors and substrates, and by competitive inhibitors such as ADMA. Furthermore, uncoupling of eNOS can result in increased production of reactive species of both oxygen (superoxide) and nitrogen (peroxinitrite), which inturn can further reduce eNOS bioavailability. A range of therapeutic targets aim at increasing bioavailability of eNOS and they are summarised here.

Increased production of ROS and peroxinitrite is associated with endothelial dysfunction. Coronary heart disease risk factors may increase NOS mediated ROS formation and peroxinitrite formation. Such risk factors are associated with decreased NO production levels in the vasculature. However, recent data suggests that reduction in bioavailable NO levels in the arteries could be due to increased local oxidative stress rather than reduction in basal NO production.

Oxidation dependent mechanisms have been implicated in endothelial dysfunction. Oxidized low density lipo-proteins (oxLDL) play an important role in early endothelial dysfunction and hence early atherosclerosis (see figure below)

oxLDL can uncouple eNOS and reduced uptake of L-ariginine that can lead to production of superoxide radical oxygen. OxLDL can interfere with NO production and lead to altered NO signalling in the vascular endothelium. In addition, different arteries can be affected differently by these physiological changes e.g. oxLDL affects carotid artery and not the basilar artery thereby implying that intracranial arteries might be protected from endothelium-mediated oxidative injury and hence atherosclerosis. And finally NO can modulate oxidation mediated apoptotic signals in the vessel wall. Hence atherosclerosis can result from the derangement of fine imbalance between NO bioavailability and local oxidative stress.

Therapeutic targets:

There are various pathways being targeted to modulate the bioavailability of eNOS and NO such as

  1. Recoupling of eNOS to cofactors and substrates

  2. Modulation of eNOS activity by genomic and non genomic mechanisms e.g. by statins, ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers , KLF2 modulators

  3. The suppression of inflammatory signalling pathways by PPAR-α activation

  4. Modulation of caeviolin mediated endocytosis and thus dissociation of eNOS from caevolin

The above list is not exhaustive, but this post here summarises recent developments in therapeutic targets in NO /eNOS regulation.

Based on:

Nitric Oxide and Pathogenic Mechanisms Involved in the Development of Vascular Diseases

Claudio Napoli and Louis J. Ignarro

Arch Pharm Res Vol 32, No 8, 1103-1108, 2009 , DOI 10.1007/s12272-009-1801-1 

 

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Positioning a Therapeutic Concept for Endogenous Augmentation of cEPCs — Therapeutic Indications for Macrovascular Disease: Coronary, Cerebrovascular and Peripheral

Author and Investigator Initiated Study: Aviva Lev-Ari, PhD, RN

 

Macrovascular Disease – Therapeutic Potential of cEPCs: Promise for CV Risk Reduction

  • Introduction
  • Biomarker Discovery – a comprehensive Post on this topic is forthcoming
  • What are our Contributions in the Domain of Macrovascular Disease – Therapeutic Potential of cEPCs: Reduction Methods for CV Risk
  • Postulates of Multiple Indications for the Method Presented: Positioning of a Therapeutic Concept for Endogenous Augmentation of cEPCs — Potential Therapeutic Indications for ElectEagle
  • A Three Component Method for Endogenous Augmentation of cEPCs — Macrovascular Diseases – Therapeutic Potential of cEPCs
  • The Promise of the Proposed Pharmacotherapy as a Method of CVD Risk Reduction
  • Emergence of Clinical Trial Results on Genous R stent — Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth – (HEALING II)
  • Conclusions
  • References

Key words: coronary artery disease, circulating Endothelial Progenitor Cells (cEPCs), Endothelial Progenitor Cells (EPC), genetic engineering, CVD, CAD, CHF, myocardial infarction, neovascularization, vascular repair, “multimarker biomarker”, macrovascular disease, Endogenous Augmentation of cEPCs, Primary Endpoint, Secondary Endpoint.

Abbreviations used: ED, endothelial dysfunction; CAD, coronary artery disease; CVD, cardiovascular disease; cEPCs, circulating Endothelial Progenitor Cells; EPC, Endothelial Progenitor Cells; CHF, congestive heart failure; MI, myocardial infarction; MNC, mononuclear cells; VEGF, vascular endothelial growth factor; BM–MNCs, bone marrow-derived mononuclear cells; G-CSF, granulocyte colony-stimulating factor; SDF, stromal derived factor; PB-MNCs, peripheral blood-mononuclear cells; EF, ejection fraction; PO2, partial pressure of oxygen; BMS, bare-metal stent; CABG, coronary artery bypass graft; DES, drug-eluting stent; GP, glycoprotein; LAD, left anterior descending; LCx, left circumflex; MI, myocardial infarction; RCA, right coronary artery; S/P , status-post stent implantation; MACE, Major Adverse Cardiac Events; TLR, target lesion revascularization; TVR, target vessel revascularization; TVF, target lesion vessel failure; eNOS, endothelial Nitric Oxide Synthase 

Introduction

Cardinal to the study of reendothelialization and neovascularization is the mechanism of action (MOA) of EPCs. It requires exact biological phenotype of the true EPC and its MOA on the endothelium. Is the EPC autocrine or paracrine in its functional role? It is critical to understand this biological unknown for planning therapeutic approaches. Patients with unstable angina and no evidence of cardiac necrosis exhibited increased cEPCs. Systemic inflammation and recognized growth factors may play a role in peripheral mobilization of EPCs in patients with unstable anginal syndromes. Proportion of cEPCs in coronary ischemia, acute or chronic and its potential for restoring left ventricular dysfunction is still experimental. EC injury facilitates an accelerated development of atherosclerotic plaque which triggers cardiovascular risk factors where the magnitude of the endothelial dysfunction predicts the level of risk for a macrovascular event (George, 2004).

Diminished level of cEPCs is associated with risk factors for CVD implicating impaired endothelial repair as a contributor to a dynamic state of endothelial dysfunction. cEPCs is further reduced if multiple risk factors for CVD are present. Endothelial dysfunction is associated with cEPCs counts. It is only if cEPCs counts are low then endothelial dysfunction (ED) emerges. In the case of ED, the cells were more senescent compared with an age group without CVD and the risk factors involved with it. Impaired repair capacity due to reduced availability of cEPCs enhances the exposure to risk factors when injury occurs due to endothelial denudation, ischemic tissue, neointima build up and remodeling.

Mobilization and EPC-mediated neovascularization is critically regulated. Statins and physical exercise are stimulatory while risk factors for CAD are inhibitory in the modulation function of the level of cEPCs. Recruitment of cEPCs requires a coordinated sequence of adhesive and signaling events including adhesion and migration by integrins, chemoattraction of SDF-1/CXCR4 and differentiation of EC.

Bone-marrow derived cells in the circulating blood have an endothelial phenotype and peripheral blood can be cultured to generate ECs. cEPCs provide both diagnostic and prognostic information on CVD. EPCs are analyzed by their phenotypic markers, as discerned by fluorescence-activated cell sorting (FACS) analysis as well as by their functional capability to produce colonies in culture conditions.

Kiernan (2006) identifies the two classes of therapeutic applications of cEPCs: (a) induction of angiogenesis and (b) large vessel repair. Transplantation of autologous EPCs over-expressing eNOS in injured vessels enhances the vasculoprotective properties of the reconstituted endothelium, leading to inhibition of neointimal hyperplasia. This cell-based gene therapy strategy may be useful in treatment of vascular disease. Stents coated in CD34 antibody which binds to the CD34 antigen of cEPCs have the capability to promote re-endothelialisation in minutes to hours. This mechanism seeks to restore the normal biology of the vessel wall rather than perpetuate the wall disruption as drug eluting stents are found recently to be implicated to cause both restenosis and thrombosis (Tung et al., 2006). Thus, cEPCs are of cardinal importance in healing cardiovascular injury. Identification of augmentation methods which are endogenous in nature, are systemic rather than local, as cell-based therapy is, and therefore, it will deliver systemic protective measures against atherosclerosis delaying angioplasty and potentially avoiding cell implantation or vascular engrafting.

Biomarker Discovery – a comprehensive Post on this topic is forthcoming

A comprehensive review of “Traditional” vs. “Novel” risk markers for cardiovascular disease was recently undertaken by Folsom et al., (2006) and the Editorial to this article by Lloyd-Jones and Tian (2006). Among the “Traditional” Risk Markers, they list: Age, Race, Sex, Total/HDL levels, Smoking Status, Diabetes, Systolic BP and Use of antihypertensive  drugs. The list of “Novel” Risk Markers is impressively longer and includes: CRP, Lp-PLA2, E-Selectin, Fibrinogen, PAI-1, Vitamin B6, D-dimer, ICAM-1, Homocysteine, IL-6, HSV-1 Antibody, CMV Antibody and Folate.

Only two risk factors make the top five list following the data adjustment to Age and /or All the Traditional Risk Factors, respectively, I would conclude that only the following two are of paramount importance for clinical application and drug therapy design.

Risk Factor RANKING

Risk Factor RANKING if

Data Adjusted to

AGE

Risk Factor RANKING if

Data Adjusted to

All “Traditional” Risk Factors

1 Chlamydia Intracellular adhesion molecule
2 Lp-PLA2 lipoprotein-associatedphospholipase A2 Cytomegalovirus
3 Tisshe Plasminogen Activator D-Dimer
4 Tissue inhibitor of Metalloproteinase1 IL-6
5 Intracellular adhesion molecule Tissue inhibitor of Metalloproteinase1

In light of these results, chiefly edified by Folsom et al., (2006)  conclusion that: “Based on the totality of evidence, however, CRP level does not emerge as a clinically useful addition to basic risk factor assessment for identifying patients at risk of a first CHD event.” (Folsom, 2006, 1372).

What are our Contributions in the Domain of

Macrovascular Disease – Therapeutic Potential of cEPCs: Reduction Methods for CV Risk

(a) This is the first paper to look at cEPCs from two academic schools of thought.  One, represented by the review article of Dzau et al., Hypertension, 2005 with 122 references which treats cEPCs from two perspectives: Vascular Biology and Molecular Cardiology. The other, is the review article by Lapidot & Petit, Experimental Hematology, 2002 with 86 references which treats cEPCs as stem cells and covers the research in Immunology and in Hematology, cEPCs is circulating in our blood, it is a stem cell! The overlap between the references N=122 in Dzau and N=86 in Lapidot & Petit is zero. These two schools do not cite the findings of the other school. That happens when both schools (Vascular Biology/Molecular Cardiology) and (Immunology/Hematology), BOTH schools are researching the same biologic phenomenon, i.e., one circulating EPC. We are the first to put together in one paper the two schools in the context of cEPCs. The pathophysiology of cECs, cEPCs and Trans-Endothelium Cell Migration in one location.

(b) Table of content of Part I yielded a theoretical treatment of cEPCs not in existence anywhere.  We defined for the first time that the Clinical Frontier for cEPCs is of quadruple nature: (Vascular Biology/Molecular Cardiology) PLUS (Immunology/Hematology). We made the statement that the Clinical Frontier has 20 Future Fast Acting Therapy modality currently under research. We cited the limitation of exogenous methods for augmentation of cEPCs as a scientifically derived justification for our selection of an endogenous augmentation method.

Upon selection of the endogenous method, we specified three components:

–   inhibition of ET-1

–   induction of eNOS

–   stimulation of PPAR-gamma

The proposed combination drug therapy yielded a new multimarker biomarker for reduction of CVD risk for macrovascular events, called the ElectEagle Version I. We specified the potential indications for the ElectEagle Version I method in terms of cardiovascular disease and co-morbidity with other endothelial dysfunction derived disease.

Method name:            ElectEagle

E.L.E.C.T.

E – Efficient

L – Ligands of cEPCs

E – Elective and Individualized Diagnosis and Therapy

C – Cardiovascular diseases & secondary sequalea

T – Treatment adjustable by three agents

E.A.G.L.E.

E – Endogenous

A – Augmentation

G – Gamma-PPAReceptor

L – Ligand occupied ETA and ETA-ETB – binding Nitric Oxide

E – EPCs fast generator

ElectEaglestands for an Efficient Ligands of cEPCs Elective and Individualized Diagnosis and Therapy for Cardiovascular diseases & secondary vascular sequalea, using Treatment adjustable by three agents. It is a method for Endogenous Augmentation of circulating EPCs by using Gamma-PPAR agonists, inhibitors of Ligand occupied ETA and ETA-ETB and agonist for binding Nitric Oxide and induce eNOS.

A Three Component Method for Endogenous Augmentation of cEPCs — Macrovascular Diseases – Therapeutic Potential of cEPCs

Observations on Intellectual Property Development For an Unrecognized Future Fast Acting Therapy for Patients at High Risk for Macrovascular events

ElectEagle represents a discovery of a novel “multimarker biomarker” for cardiovascular disease that innovates on four counts.

First, it proposes new therapeutic indications for acceptable drugs.

Second, it defines a specific combination of therapeutic agents, thus, it put forth a proprietary drug combination.

Third, it targets receptor systems that have not been addressed in the context of cEPCs augmentation methods. Chiefly, modulation of the following three-targeted receptor systems: (a) inhibition of ET-1, ETA and ETA-ETB receptors by antagonists (b) induction of eNOS, by agonists and NO stimulation and (c) upregulation of PPAReceptor-gamma by agonists (TZD). While (b) and (c) are implicated as having favorable effects of cEPCs count, each exerting its effect by a different pathway, it is suggested in this project that (a) might be identify to be the more powerful of the three markers. Our method, ElectEagleis the FIRST to postulate the following: (1) time concentration dependence on eNOS reuptake (2) dose concentration dependence on NO production (3) time and dose concentration dependence for ET-1, ETA and ETA-ETB inhibition, and (4) dose concentration dependence on PPAReceptor-gamma. Points First, Second and Third are covered in Part II where a special focus is placed on ET-1, ETA and ETA-ETB receptors.

Fourth, ElectEagle proposes a platform with triple modes of delivery and use of the test, as described in Part III. The triple modes are as follows: (A) an automated platform from a centralized lab with integration to Lab’s information management system. (B) a point-of-care testing device with appropriate display of test results (small benchtop analyzers in PCP office). (C) a device used for home monitoring of analytes (the hand-held device facilitates rapid read of scores and their translation to drug concentration of each of the three therapeutic agents, with computation of the three drug concentrations done by the device. Thus, it offers quicker optimization of treatment.  ElectEagle is the FIRST to propose a CVD patient kit, hand-held device, which calculates on demand an adjustable therapeutic regimen as a function of cEPCs count biomarker. In this regard, a similarity to the pump, in management of blood sugar in DM patients, exists. Since there is a high co-morbidity between DM and CVD, our methods, ElectEagle may eventually become a targeted therapy for the DM Type 2 population.

Postulates of Multiple Indications for the Method Presented: Positioning of a Therapeutic Concept for Endogenous Augmentation of cEPCs — Potential Therapeutic Indications for ElectEagle

ElectEagle can become the drug therapy of choice for the following indications:

  •      CAD patients
  •      Endothelial Dysfunction in DM patients with or without Erectile Dysfunction
  •      Atherosclerosis patients: Arteries and or veins
  •      pre-stenting treatment phase
  •      post-stenting treatment phase
  •      if stent is a Bare Metal stent (BMS)
  •      if stent is Drug Eluting stent (DES)
  •      if stent is EPC antibody coated (the ElectEagle method increase cEPCs generation in vitro) so availability of cEPCs is increased
  •      post CABG patients (the ElectEagle enhances healing by endogenous augmentation of cEPCs)
  •      target sub segments of CVD patients on blood thinner drugs (the ElectEagle does not require treatment with antiplatelet agents, it is suitable for all patients on Coumadin. This population have a counter indication for antiplatelet agents which is a follow up treatment after stent implantation for 30 days, with stent-eluting long term regimen of antiplatelet agents, 6 months and in some cases indefinitely (Tung, 2006).
  •      ElectEagle is based on systemic therapeutics (versus the localized stent solution requiring multiple and even overlapping stents)
  •      ElectEagle will be having potential in three contexts

(a) Coronary disease

(b) Periphery vascular disease

(c) Cerebrovascular

Comparative analysis of endogenous and exogenous cEPCs augmentation methods:

A. Endogenous augmentation method properties:

  •         temporal – while drug therapy in use – drug action is interruptible
  •         time concentration on eNOS reuptake
  •         dose concentration on NO production
  •         time and dose concentration manner for ETB inhibition
  •         dose concentration on PPAR-gamma

B.  Cell-based and other exogenous methods

  • permanent colonization till apoptosis if no repeated attempts of re-transfer,
  • re-implantation as the protocol usually has several stages

The Promise of the Proposed Pharmacotherapy as a Method of CVD Risk Reduction

It is expected that ElectEagle will be resulting in potential delay of stenting implantation. Patients that are target for stenting may benefit form ElectEagle that will facilitate and accelerate healing after the stent is in place. EPC antibody coated stents will work if and only if the patient has more that just low cEPCs, most patient undergoing stenting tend to have low level of cEPC. The ElectEagle method can be coupled with that type of new stents, called Genous, now in clinical trials (HEALING II, III). These stents enhance the body ability in mobilization of cEPCs, only. However, if the initial population of cEPCs is low, an endogenous fast acting cell augmentation method is needed for pretreatment before the PCI procedure with Genous is scheduled.

Emergence of Clinical Trial Results on Genous R stent — Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth – (HEALING II)

Latest publications on HEALING II – Clinical Trial of EPC coated stent

Genous R stent
n=63
Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth – II

S Silber et al; 12 Month Outcomes of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) Worldwide Registry; EuroIntervention 2011;6:819-825

P Damman et al; Coronary Stenting With the Genous Bio-engineered R stent in Elderly Patients – 12-month Outcomes From the e-HEALING Registry; Circulation Journal 2011;75(11):2590-2597

P Damman et al; Twelve-month Outcomes After Coronary Stenting With the Genous Bio-Engineered R Stent in Diabetic Patients from the e-HEALING Registry; Journal of Interventional Cardiology 2011;24(4):285-94 

J Aoki et al; Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry.J.Am.Coll.Cardiol. 2005 May 17;45(10):1574-9

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Cardiovascular Outcomes: Function of circulating Endothelial Progenitor Cells (cEPCs): Exploring Pharmaco-therapy targeted at Endogenous Augmentation of cEPCs

Author and Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 1/25/2018

The secret to building a strong heart lies in blood vessels, Stanford researcher find

Curiously, blood flow through those missing vessels – and the oxygen it provides – is only part of the story. In a follow-up experiment, the researchers grew heart muscles in a dish along with endothelial cells that had not yet formed into blood vessels. The team found that when those endothelial cells produced no Ino80, the heart muscle didn’t develop properly. Apparently, Red-Horse said, “endothelial cells are producing something that’s a growth factor” for cardiac muscle cells. “The next step is to identify that factor.”

https://news.stanford.edu/2018/01/25/secret-building-strong-heart-blood-vessels/

This is a post in Clinical Cardiology Frontiers:

  • Resident-Cell-based Therapy and
  • Molecular Cardiology

An Overview of the State of  Science on Circulating Endothelial Progenitor Cells (cEPCs) and Cardiovascular Outcomes: Exploring Pharmaco-therapy targeted at Endogenous augmentation of cEPCs

 

Werner (2005) reported that after 12 months a total of 43 participants died, 23 from cardiovascular(CV) causes. A first major cardiovascular event occurred in 214 patients in 519 patients with coronary artery disease as confirmed on angiography. Endothelial progenitor cells (EPCs) derived from bone marrow are believed to support the integrity of the vascular endothelium. His study identified that the number and function of endothelial progenitor cells correlate inversely with cardiovascular risk factors, but the prognostic value associated with circulating endothelial progenitor cells has not been defined. The level of circulating CD34+KDR+endothelial progenitor cells predicts the occurrence of cardiovascular events and death from cardiovascular causes and may help to identify patients at increased cardiovascular risk. The number of endothelial progenitor cells positive for CD34 and kinase insert domain receptor (KDR) was determined with the use of flow cytometry, they evaluated the association between baseline levels of endothelial progenitor cells and death from cardiovascular causes, the occurrence of a first major cardiovascular event (myocardial infarction, hospitalization, revascularization, or death from cardiovascular causes), revascularization, hospitalization, and death from all causes (italics added).

Werner (2005) reported that after 12 months a total of 43 participants died, 23 from cardiovascular(CV) causes. A first major cardiovascular event occurred in 214 patients in 519 patients with coronary artery disease as confirmed on angiography. Endothelial progenitor cells (EPCs) derived from bone marrow are believed to support the integrity of the vascular endothelium. His study identified that the number and function of endothelial progenitor cells correlate inversely with cardiovascular risk factors, but the prognostic value associated with circulating endothelial progenitor cells has not been defined. The level of circulating CD34+KDR+endothelial progenitor cells predicts the occurrence of cardiovascular events and death from cardiovascular causes and may help to identify patients at increased cardiovascular risk. The number of endothelial progenitor cells positive for CD34 and kinase insert domain receptor (KDR) was determined with the use of flow cytometry, they evaluated the association between baseline levels of endothelial progenitor cells and death from cardiovascular causes, the occurrence of a first major cardiovascular event (myocardial infarction, hospitalization, revascularization, or death from cardiovascular causes), revascularization, hospitalization, and death from all causes (italics added).

In light of the inverse correlation found between CV risk and enumeration and function of cEPCs, this study proposes a pharmaco-therapeutic method to enhance the cell count by a method of endogenous augmentation as presented in Part II and called ElectEagle.

 

Phenotypic Identification of Circulating Endothelial Progenitor Cells (cEPCs)

 

In the current state of science on cEPCs, the definition of these cells is ambiguous, as found in Fadini et al. (2004) letter to the Editors of Heart. On this subject, additional five letters were addressed to NEJM Editor in 2005, in reference to Werner et al. (2005) article Correspondence titled: Circulation Endothelial Progenitor Cells. Werner et al. (2005) was in fact the stimulant for this project which takes his result as a starting point and carries the research into pharmaco-therapy and device design for diagnostic based on a quantitative model derived from Werner’s data.

In the article in Heart, peripheral blood CD34+ cells are defined as endothelial progenitor cells. In Fadini’s concern he notes that cEPCs represent a subset of peripheral blood mononuclear cells (PBMNCs) expressing immature surface markers common to hematopoietic stem cells and endothelial lineage markers. By contrast CD34 represents a marker of immature staminal cells that may be used to characterize EPCs together with other surface antigens, but that identifies not only EPCs. Peripheral blood CD34+ cells form a very heterogeneous pool containing also CD45+ cells (lymphatic precursors), CD14+ cells (monocyte/macrophage lineage precursors) and other non-hematopoietic cells not belonging to the endothelial lineage.

Fadini’s concern is supported by George et al. (2006), who concluded that current methods for quantitatively assessing numbers of circulating EPC are not correlated. George’s findings may suggest that CD34/KDR is more appropriate for the definition of circulating EPC, whereas CFU (colony forming Unit) numbers are more likely to reflect their ability to proliferate. Fadini’s research supports the percentage of EPCs among the CD34+ pool vary widely from patient to patient and, in the same patient, under different pathophysiological conditions, indicating possible peripheral differentiation rather than bone-marrow mobilization. His observation is supported by Lapidot & Petit (2002) and Hur et al., (2004).

Furthermore, CD133 is considered the best surface marker to define, identify and isolate circulating EPCs. Even if the exact phenotype of EPCs has not been clearly established, additional markers reflecting endothelial commitment, including Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2 or KDR), Platelet-Endothelial Cells Adhesion Molecule-1 (PECAM-1 or CD31), Vascular Endothelial-Cadherin, von Willebrand Factor, c-kit, Tie-2 and VEGFR-1, are required. Using flow cytometry less than 0,001% of PBMNCs is identified as EPCs, but two or three markers are needed to avoid unspecific count. Thus minimal requirement to identify EPCs should be the parallel use of CD34 (or CD133) and KDR expression, as supported by George (2006).

Thus, he suggests that PBMNCs-derived CD34+ cells may not be used to identify EPCs. Fadini suggests that if we consider that EPCs or CD34+ cells stimulate angiogenesis in a paracrine way by means of producing growth factors, then, it would be more appropriate to call them “Circulating Angiogenic Cells” (CACs) as already proposed. EPCs reduction and endothelial dysfunction as observed by circulating cells and vascular wall cells of diabetic patients are exposed to high oxidative stress, thus increased apoptosis or reduced peripheral differentiation are likely to explain low EPCs counts. Several other clinical conditions characterized by poor endothelial function, like diabetes mellitus, obesity, hypertension, autoimmune disorders (such as Systemic Lupus Erythematosus), chronic renal diseases, etc., all are likely to be influenced by EPCs reduction (Fadini, 2004).

The five letters to NEJM Editor, Kim et al (2005) are of great scientific merit and of great interest to this project. We are developing new intellectual property (IP) in several forms in Part II and Part III. The IP in Part III is actually using Werner et al. (2005a) data, for our method called ElectEagle. Therefore, here, Werner’s (2005b) points will be considered as his reply to the five letter correspondence and no discussion of the content of the five letters is presented.

  •           Werner & Nickenig (2005b) disagree with Bertolini et al. that CD34+KDR+ cells are mature circulating endothelial cells. Endothelial cells are predominantly identified by the presence of CD146 (and results of Boos et al., as described in their letter).
  •           In Werner et al (2005a), CD146+ circulating endothelial cells were not predictive of cardiovascular outcomes, which indicates that CD34+KDR+ cells differ substantially from circulating endothelial cells (unpublished data). It is an accepted standard to identify circulating endothelial progenitor cells by the presence of CD34 and KDR.
  •           To confirm the results, Werner et al (2005a) measured CD133+ endothelial progenitor cells and obtained similar results, which appear in the online Supplementary Appendix to our article.
  •           Drs. Ott and Taylor suggest calculating the absolute number of endothelial progenitor cells with the use of peripheral-blood mononuclear cells or lymphocytes. However, absolute cell counts measured by flow cytometry can be determined only with the use of enumeration systems (e.g., flow count beads).
  •           At present, we cannot think of a major advantage to measuring the absolute number of endothelial progenitor cells. The method provided allows a single measurement that is easy to perform, highly predictive, and transferable to other laboratories.
  •           Dr. Kim and Dr. Leu and colleagues address  the role of endothelial progenitor cells in acute coronary syndromes and acute myocardial infarction. Only one study has investigated the mobilization of CD34+KDR+ endothelial progenitor cells in myocardial infarction, whereas other studies have measured CD34+ cells or non–endothelial progenitor cell subfractions.
  •           None of the studies have systematically looked at the time course directly after acute myocardial infarction, owing to the fact that the exact onset of myocardial infarction is difficult to determine. Treatment of myocardial infarction requires the administration of multiple drugs that may influence the number of endothelial progenitor cells. Therefore, current data on progenitor cells in myocardial infarction are questionable.
  •           In order to elucidate the mobilization of endothelial progenitor cells after myocardial infarction, Werner et al (2005a) measured the number of CD34+KDR+ cells in patients undergoing transcoronary ablation of septal hypertrophy (unpublished data). Preliminary results indicate that directly after myocardial infarction, the number of endothelial progenitor cells decreases as a result of consumption of cells within the ischemic region. The increase in cells described previously may be due to medical treatment.
  •           No patient who was included in the study had had a recent ischemic event, so misclassification of patients was not an issue.
  •           Werner et al. (2005a) did not find an association between high sensitivity CRP measures and the number of endothelial progenitor cells. To their knowledge, there are no data available on the association between endothelial progenitor cells and inflammatory markers in a similar population of patients. Data that are available come from in vitro, animal, and small-scale studies investigating the role of endothelial progenitor cells in acute coronary syndromes. Since their study population consisted mainly of patients with stable coronary artery disease, this may explain the lack of an association.

Circulating Endothelial Cells (cECs) and Circulating Endothelial Progenitor Cells (cEPCs)

Vascular endothelial cells (EC) respond to numerous pathophysiological stimuli such as growth factors, cytokines, lipoproteins, and oxidative stress. Prolonged or unregulated activation of these cells often results in a loss of EC integrity and, thus, dysfunction—a process that can be assessed by the use of specific plasma markers such as von Willebrand factor (vWf), tissue plasminogen activator, soluble EC protein C receptor, soluble E selectin, and soluble thrombomodulin, as well as physiological techniques such as flow-mediated dilatation (FMD). Indeed, endothelial perturbation in cancer may well contribute to an increased risk of thrombosis in these patients. (Goon et al., 2006)

The presence of circulating endothelial cells (cECs) has recently been recognized as a useful marker of vascular damage. Usually absent in the blood of healthy individuals, cECs counts are elevated in diseases hallmarked by the presence of vascular insult, such as sickle cell anemia, acute myocardial infarction, Cytomegalovirus (CMV) infection, endotoxemia, and neoplastic processes. Current opinion suggests toxemia, that cECs are cells driven from the intima after vascular insult, and are thus the consequence—rather than the initiator—of a particular pathology (Goon et al., 2006).

A related circulating cell population are endothelial progenitor cells (cEPCs), which originate from the bone marrow, rather than from vessel walls. Seen in small numbers in healthy individuals, their numbers tend to increase following vascular injury. So far, experiments have established the ability of EPCs to form colonies in vitro, suggesting a role in both angio-genesis and in the, maintenance of existing vessel walls.

CEC are generally accepted as cells expressing endothelial markers [e.g., vWf, CD146, and vascular endothelial cadherin (VE-cadherin)] in the absence of hematopoietic (CD45 and CD14) and progenitor (CD133) markers. Interestingly, the progenitor marker CD34 is also present on mature cECs. Although CD146 is widely regarded as the principal marker for cECs (mature cell form), it has also been described in trophoblasts, mesenchymal stem cells, periodontal and malignant (prostatic cancer and melanoma) tissues, and activated lymphocytes (Goon et al., 2006).

Optimal Method for cECs and cEPCs Quantification (Cell Count) Remains Unknown

“Together with EPCs, cECs only represent between 0.01% and 0.0001% of mononuclear cells in normal peripheral blood (Khan et al. (2005), making it very difficult to accurately quantify their numbers. To do this, it is often necessary to employ cell enrichment techniques combined with specific cell marker labeling.  The immunobead capture method (immunomagnetic beads bearing CD146 antibodies) developed by George et al. (1992) is the most widely used. Immunobeads have been successfully employed by other investigators, albeit with modifications [e.g., addition of EDTA and albumin to minimize cECs autoaggregation; drying cECs on a glass slide before counting (this enables storage at room temperature and secondary labeling); use of UEA-1 (an EC-specific stain); addition of an Fc receptor blocking agent, and double labeling for further analyses (e.g., for CD31 and CD34)]. After cell separation, either fluorescence microscopy, immunocyto-chemistry, or flow cytometry is used to confirm the endothelial chemistry, phenotype of the cells. Other methods used to concentrate mononuclear cell suspensions include standard and density (Lymphoprep, Axis-Shield, Oslo, Norway; Percoll, Sigma, St. Louis, MO; Ficoll, Sigma) centrifugation and mononuclear cell culturing on fibronectin-coated plates. The main alter- alternative to the immunobead method is flow cytometry” (Goon, 2006).

Werner et al. (2005a) used the following method for Flow Cytometry — For fluorescence-activated cell-sorting analysis, mononuclear cells were resuspended in 100 µl of a fluorescence-activated cell-sorting buffer containing phosphate-buffered saline, 0.1 percent bovine albumin, and aprotinin (20 µl per milliliter). Immunofluorescent cell staining was performed with the use of the fluorescent conjugated antibody CD34–fluorescein isothiocyanate (FITC) (10 µl; Becton Dickinson), KDR (kinase insert domain receptor), and CD133–phycoerythrin (PE) (10 µl; Miltenyi). For the identification of KDR+ cells, indirect immunolabeling was performed with the use of a biotinylated goat mononuclear antibody against the extracellular domain of human KDR (R&D Systems). IgG2a–FITC–PE antibody (Becton Dickinson) served as a negative control. For staining of KDR, extensive blocking was required with the use of human immunoglobulin (polyglobulin, 10 percent; Bayer) and goat serum (Sigma-Aldrich). Cell fluorescence was measured immediately after staining, and data were analyzed with the use of CellQuest software (FACS Calibur, Becton Dickinson). Units of all measured components are absolute cell counts obtained after the measurement of 10,000 events in the lymphocyte gate. To assess the reproducibility of the measurements, two separate blood samples were obtained, on days 0 and 7, from 10 subjects. The intraclass correlation between the two probes was 0.94. Probes were measured at the same time of day, with identical instrument settings, by two investigators. For each patient, a corresponding negative control with IgG2a–FITC–PE antibody was obtained.

Colony-Forming Units of Endothelial Cells (Werner et al. 2005a)

In an endothelial basal medium (CellSystems) with supplements, 1×107 mononuclear cells were seeded on human fibronectin–coated plates (Sigma-Aldrich). After 48 hours, 1×106 nonadherent cells were transferred into new fibronectin-coated wells to avoid contamination with mature endothelial cells and nonprogenitor cells.22 After seven days in vitro, endothelial colony-forming units in at least three wells were counted by two independent investigators. Colony-forming units of endothelial cells are expressed as absolute numbers of colonies per well. (Werner, et al. 2005)

George et al. (2006) reports using the following method while performing an analysis of several methods used for cEPCs assessment and correlated them with humoral factors known to influence their numbers:

Peripheral blood mononuclear cells were obtained and stained for FACS analysis with antibodies to CD34, CD45, CD133, and KDR and the remaining cells grown under endothelial cell conditions for assessment of colony-forming unit (CFU) numbers and adhesive properties. Levels of circulating vascular endothelial growth factor (VEGF), erythropoietin (EPO), and C-reactive protein (CRP) were determined and correlated with each of the EPC markers.

Pathophysiology of cECs

The endothelium can be viewed as a membrane-like layer lining the circulatory system, its primary function being the maintenance of vessel wall permeability and integrity. The EC layer is relatively quiescent, with an estimated cell turnover period of between 47 and 23,000 days, as shown by labeling studies. Proliferation seems to occur mainly at sites of vasculature branching and turbulent flow. cECs are thought to have ‘‘sloughed off’’ vessel walls, indicating severe endothelial damage. Thus, unsurprisingly, cECs have been shown to correlate with various endothelial dysfunction and inflammatory markers.

Although not fully understood, it would appear that cECs detachment from the endothelium involves multiple factors, such as mechanical injury, alteration of endothelial cellular adhesion molecules (such as integrin alphaVbeta3), defective binding to anchoring matrix proteins (such as fibronectin, laminin, or type IV collagen), and cellular apoptosis with decreased survival of cytoskeletal proteins. The net effect is a reduced interaction between the EC and basement membrane proteins, with subsequent cellular detachment (Goon et al. 2006).

 

Pathophysiology of cEPCs

In Science 1997, Asahara et al. was the first to isolate EPC in human peripheral blood, using anti-CD34 monoclonal antibodies. With the use of CD133, an antigen specifically identifying primitive stem cells, a novel means to precisely delineate mature (cECs) from immature (cEPCs) EC forms was possible (Asahara et al. 1997), although this antigen is only present in human EPCs and cannot be applied to mouse EPCs (Rafii et al. 2003). To detect cEPCs in peripheral blood, Flow Cytometry and culture have become the principal methods employed. Other markers used include vWf, VE-cadherin, vascular endothelial growth factor receptor-2 (VEGFR-KDR) and binding by lectins and acetylated low-density lipoproteins (Peichev et al. 2000, Rafii et al. 2003).

cEPCs are potentially crucial for neovascularization and may be recruited from the bone marrow after tissue ischemia, vascular insult, or tumor growth (Rafii et al. 2003). They possess the ability to migrate, colonize, proliferate, and, ultimately, differentiate into endothelial lineage cells. These cells have yet to acquire mature ECs characteristics while appearing to contribute to vascular homeostasis.

cEPCs have been isolated previously from human umbilical cord blood, adult bone marrow, human fetal liver cells, and cytokine-mobilized peripheral blood, and an increase in cEPCs follows in vivo administration of the angiogenic growth factor VEGF. When incubated with VEGF, fibroblast growth factor-2 (FGF-2), and insulin-like growth factor, CD133+ cells differentiated into mature-type adherent EC, expressing endothelial-specific cell markers (vWf and VE-VE cadherin) and abolishing CD133 expression (Goon, 2006). Generation of endothelial outgrowths that are positive for CD146, vWf (mature endothelial growth markers), and CD36 (a representative scavenger receptor marker as well as a microvascular marker) markers from circulating mononuclear cells (of donor genotype in bone marrow transplant patients), strongly suggests the viability and proliferative potential of cEPCs.

cEPCs recruitment and mobilization have been positively correlated with increased levels of angiogenic growth factors such as VEGF which induces the proliferation, differentiation, and chemotaxis of cEPCs, and is essential for hematopoiesis, angiogenesis, and, ultimately, survival.  cEPCs influence cells mainly by interactions with VEGFR-1 and VEGFR-2, both being receptors expressed on hematopoietic stem cells (HSC) and cEPCs. In another study, granulocyte colony-colony stimulating factor also increased the number of CD34 stimulating CD34+ cells, potentially stimulating neovascularization in areas of is- ischemic myocardium Other angiogenic growth factors stimulating cEPCs mobilization include angiopoietin-1, FGF, SDF-1, PlGF, and (in mice) macrophage colony-stimulating factor. After mobilization, cEPCs appear to “home in” and become incorporated into sites of vascular injury and ischemia, with evidence of improvement in the function and viability of tissue (e.g., after acute myocardial infarction) (Kocher et al. 2001).

Chemotactic agents responsible for this process include VEGF and SDF-1, but others may also be involved. In the clinical setting, moderate exercise of patients with stable coronary artery diseases leads to a significant increase in cEPCs (Laufs et al. 2004). Furthermore, cEPCs and HSC introduced into the circulation of acute and chronic cardiovascular disease patients through injection have shown vascular encouraging preliminary results, with evidence of improved cardiovascular function and tissue perfusion Tse et al. (2003); as of yet, there are no randomized control trial!

Recent reports suggest that cECs and cEPCs enumeration can be used to monitor antiangiogenesis drug therapy with some success. This exciting prospect needs to be fully corroborated in a clinical setting. In addition, cECs and cEPCs monitoring would need to be efficient, specific, robust, and reproducible. Therefore, it is vital to reach a general consensus regarding definitions and techniques for cECs and cEPCs quantification, in order to validate further reports that have implications for future clinical trials involving these markers (Goon, 2006).

In 2002, matrix metalloproteinase-9 (MMP-9) was identified as the molecular key to the release of EPCs from the bone-marrow compartment via cleavage of membrane kit ligand (Heissig et al., 2002). MMP-9 activity has also been shown to be upregulated by SDF-1alpha, VEGF, and hypoxia. Hypoxia is a potent stimulus for neovascularization, ischemia-induced growth, EPC trafficking and upregulation, vascular malformations and malignant endothelial cell tumors. This include activation of two upstream mediators of vasculogenesis, SDF-1 alpha and MMP-9, during the proliferative phase via EPC mediated vasculogenesis when these stem cells may rapidly proliferate in the ischemic tissue resulting in growth.

How a mobilized population of progenitor cells homes to ischemic tissue under repair was examined using bone-marrow transplantation studies. Following this procedure, reconstitution is regulated by chemokine ligand-receptor pair, stromal-cell derived factor 1 (SDF-1) and CXCR4 (Lapidot & Petit, 2002 reporting their discovery of 1999). EPCs express CXCR4, CXCR4/SDF-1 signal for EPC homing to peripheral sites of neovascularization. EPC SDF-1alpha expression was increased in proportion to reduced oxygen tension and this correlated with EPC localization in the most ischemic tissue sections (Kleinman, et al. 2005).

Table 1: Humoral factors known to influence eCPCs numbers

CD34 CD45 CD133 KDR CD34/KDRMost appropriate Definition of cEPCs CD34/CD133/KDR CD34/CD133 Adhesive properpies
VEGF level corr Positive correlation
EPO
CRP
CFU Colony forming unit numbersReflects cEPCs ability to proliferate No corr No corr Negative correlation Positive correlation
Adhesive properties No corr No corr No corr No corr
CD34
CD45
CD133
KDR
CD34/CD133/KDR Positive correlation
CD34/CD133 No corr

 SOURCE:

Table 1 is constructed from data in George et al. (2005),(2006) who concluded that current methods for quantitatively assessing numbers of circulating EPC are not correlated. VEGF serum levels are associated only with CD34/KDR and CD34/ CD133/KDR, whereas CFU numbers correlate with EPC functional properties. These findings may suggest that CD34/KDR is more appropriate for the definition of circulating EPC, whereas CFU numbers are more likely to reflect their ability to proliferate.

 

Trans-Endothelium Cell Migration

Lapidot and Petit in a recent review of the stem cell mobilization research field concluded that the following are the seminal processes at work in the facilitation of transendothelium cell migration. These processes could mediate stem cell release and remodeling of the bone marrow microenvironment, followed by stem cell migration via the circulation, homing back to the bone marrow and repopulation of damaged/restructured sites in an organ as part of the continuous replenishment of the blood with new immature and maturing cells while maintaining undifferentiated stem cells (Lapidot and Petit, 2002).

  •       Regulation of hematopoietic stem cell release, migration, and homing to the bone marrow, as well as the mechanism of different mobilization pathways, involve a complex interplay between adhesion molecules, chemokines, cytokines, proteolytic enzymes, stromal cells, and hematopoietic cells, the mechanism is not fully understood;
  •       The chemokine, stromal derived factor-1 (SDF-1)and its receptor CXCR4 play a major role in stem cell mobilization, including granulocyte colony-stimulating factor (G-CSF) and G-CSF with the chemotherapeutic agents cyclophosphamide Cy-induced mobilization, as well as in stem cell homing to the bone marrow and anchorage (i.e., activation of adhesion interactions in order to retain stem cells within the organ).
  •       They suggested that in addition to SDF-1 degradation and inactivation within the bone marrow by proteolytic enzymes such as neutrophil elastase, which is essential for optimal stem cell mobilization, interactions between this chemokine and its receptor are also needed for stem cell release and mobilization. For example, they suggested that IL-8, which is secreted in response to SDF-1 stimulation, and MMP-2 and MMP-9, which are mostly secreted by neutrophils but are also secreted by immature human CD34+ progenitor cells in response to stimulation with this chemokine, can also lead to migration away from the bone marrow across the endothelium into the circulation also in the absence of or against a gradient of SDF-1 under shear flow forces within the extravascular space of the bone marrow (Cinamon et al., 2001).
  •        They suggest that in order to maintain stem cells in the circulation low levels of surface CXCR4 are required and may be achieved by factors in the blood plasma such as proteolytic enzymes that can also cleave CXCR4 in addition to SDF-1 . Valenzuela-Fernandez (2002). Furthermore, increase in the levels of CXCR4 expression on the surface of stem cells in the circulation will mediate their homing and reengraftment of the bone marrow as part of homeostatic regulation of leukocyte trafficking as well as steady-state hematopoiesis and stem cell self-renewal, which go hand in hand with bone destruction and bone remodeling. However, this hypothesis is also an oversimplification of a much more complex and dynamic situation with physiological steady-state homeostatic as well as stress-induced mobilization situations in which the mechanisms and mode of regulation are still poorly understood.
  •        A significant number of studies in the past few years have revealed insights into regulation of hematopoietic stem cell release, migration, and homing as well as the mechanism of different mobilization pathways. However, the exact sequence of events involving many different molecules is still not clear. More importantly, in addition to results from clinical mobilization protocols using Cy and G-CSF, which demonstrate a role for SDF-1 and CXCR4 interactions in immature human CD34+ cell mobilization, two recent reports also demonstrate a role for these interactions in autologous and allogenic CD34+ cell homing and repopulation.
  •        Taken together, these results suggest that stem cell homing and release or mobilization are mirror images utilizing a similar mechanism and suggest manipulation of SDF-1/CXCR4 interactions in order to improve stem cell mobilization or to target migration of transplanted cells to specific organs. These results strongly support the idea that increasing the migration potential of immature human CD34+ cells prior to transplantation, either by short term stimulation with SCF and IL-6 and/or by cotransplantation with accessory cells. It could also increase homing and repopulation in transplanted patients, leading to improved treatment efficiencies and cure rates in clinical protocols.

 

Prospects and Limitations of Exogenous methods for cEPCs Augmentation

ElectEagle represents a conceptual formulation for several strategies to increase cEPCs number endogenously.

Additional posts on this Scientific Web Site on related topics are:

Lev-Ari, A., (2012S). Endothelial Dysfunction, Diminished Availability of cEPCs, Increasing CVD Risk for Macrovascular Disease – Therapeutic Potential of cEPCs

http://pharmaceuticalintelligence.com/2012/08/27/endothelial-dysfunction-diminished-availability-of-cepcs-increasing-cvd-risk-for-macrovascular-disease-therapeutic-potential-of-cepcs/

Lev-Ari, A., (2012T). Vascular Medicine and Biology: CLASSIFICATION OF FAST ACTING THERAPY FOR PATIENTS AT HIGH RISK FOR MACROVASCULAR EVENTS Macrovascular Disease – Therapeutic Potential of cEPCs

http://pharmaceuticalintelligence.com/2012/08/24/vascular-medicine-and-biology-classification-of-fast-acting-therapy-for-patients-at-high-risk-for-macrovascular-events-macrovascular-disease-therapeutic-potential-of-cepcs/

Below, this method is contrasted with exogenous methods involving the cell-based vascular therapy approaches currently applied for angiogenesis (mature cell-derived generation of new vessels), vasculogenesis (EPC-dependent generation of new vessels), neovascularization (ischemic tissue) and re-endothelialization (injured blood vessel.)  The majority of these methods are exogenous involving implantation or transplantation of various kinds: genetically engineered vein grafts, vascular bioprosthesis, retroviral transduction of genetic modifications to over-express a therapeutic gene(s).Despite the hurdles quoted below, the outlook for EPC-based therapy for cardiovascular disease is promising.Among the remaining outstanding issues in this fast growing research discipline, Dzau et al., chart a perspective for future research directions (Dzau et al. 2005)

“Despite the encouraging results regarding the therapeutic potential of EPCs, several issues currently stand in the way of their wide clinical application. Strategies need to be developed to enhance the number of EPCs to allow the harvesting of adequate number for therapeutic application. The limited ability to expand PB-MNC–derived EPCs in culture to yield sufficient number for clinical application indicates that alternative sources of cells (i.e., chord blood) or strategies to increase their number endogenously need to be explored. We believe that further characterization of the biology of EPCs, the nature of the mobilizing, migratory and homing signals, and the mechanisms of differentiation and incorporation into the target tissues need to be identified and further characterized. Strategies to improve retention and survival of the transplanted cells need to be developed as well. The issues of the timing of cell administration, the appropriate clinical condition, the optimal cell number, and, most importantly, the safety of cell transplantation must be defined. There is urgent need to standardize the protocols for isolation, cultivation, and therapeutic application for cell-based therapy. Finally, large-scale randomized, controlled, multi-centric trials will be essential to evaluate the long-term safety and efficacy of EPC therapy for treatment of tissue ischemia and vessel repair amid concerns of potential side effects such as neovascularization of occult neoplasias and the development of age- and diabetes-related vasculopathies. Despite these hurdles, the outlook for EPC-based therapies for tissue ischemia and blood vessel repair appears promising. Genetic engineering of EPC may provide an important strategy to enhance EPC mobilization, survival, engraftment, and function, thereby rendering these cells efficient therapeutic modalities for cardiovascular diseases.” (italics added).

In the Brief Review in Hypertension, Dzau et al., list several serious potential problems with therapeutic use of EPCs (Dzau et al. 2005)

“Although the preclinical and clinical studies reviewed here generally lend support to the therapeutic potential of autologous EPCs in the treatment of tissue ischemia and repair of injured blood vessels, the clinical application of EPCs is limited by several factors. First, the scarcity of cEPCs makes it difficulty to expand sufficient number of cells for therapeutic application without incurring the risk of cell senescence and change in phenotype (Asahara, et al., 1997, 1999). Furthermore, EPCs from patients with cardiovascular diseases display varying degrees of functional impairment (Vasa et al., 2001a, 2001b), (Hill et al., 2003), (Heeschen et al., 2004), (George et al., 2003), (Loomans et al., 2004), (Tepper et al., 2002). Aging and diabetes markedly reduce the availability and impair the function of EPCs (Hill et al., 2003), (Loomans et al., 2004), (Tepper et al., 2002), (Schatteman et al., 2000), (Scheubel et al., 2003), (Edelberg et al., 2002). Because older and diabetic patients are the most vulnerable populations for cardiovascular diseases, this severely restricts the ability to treat with autologous EPCs the patients who theoretically need them most.

The purity and developmental stage of the cells used for transplantation are important factors. Yoon et al reported recently that injection of total bone marrow cells into the heart of infarcted rats could potentially lead to severe intramyocardial calcifications (Yoon et al., 2004). In contrast, animals receiving the same number of clonally expanded bone marrow cells did not show myocardial calcification. Thus, this finding brings attention to the potential risks of transplanting unselected bone marrow cells and cautions against their premature use in the clinical setting.

Exogenous mobilization of bone marrow with hematopoietic growth factors and other endothelial cell growth factors may recruit progenitor cells to sites of occult neoplasia, leading to vascularization of dormant tumors. In addition, mobilization could potentially accelerate progression of atherosclerotic plaque by recruiting inflammatory and vascular smooth muscle cell progenitor cells into the plaque, contributing to neointima hyperplasia and transplant arteriopathy (Caplice et al., 2003), (Sata et al., 2002). Increased rate of in-stent restenosis led recently to the cancellation of the MAGIC clinical trial using G-CSF for endogenous mobilization of progenitor cells in patients with myocardial infarction.120 Finally, there has been one study that has shown evidence that EPC may themselves contribute to allograft vasculopathy by promoting neovascularization of the plaque(Hu et al., 2003). However, another study failed to show evidence that EPCs contribute significantly to transplant arteriosclerosis (Hillebrands et al., 2003).”

In accordance with this account is the latest review of EPC as therapeutic vectors in CV disorders covering experimental models and human trials (Ben-Shoshan and George, 2006).

The conceptual formulation for several strategies to increase cEPCs number endogenously presented in this investigation is complementary to methods currently applied or are still in clinical trials, as reviewed by Dzau et al. (2005). However, our approach, ElectEagle, involves endogenous augmentation of cEPCs by development of a concept-based protocol for therapeutic treatment using three components:

  •                Inhibition of ET1, ETB
  •                Induction of NO production and stimulation of eNOS
  •                Treatment Regimen with PPAR-gamma agonists (TZD) 

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) is used to reconstitute flow into post-stenotic, chronically underperfused myocardium. This post-stenotic myocardium consists of connective tissue scars, dying cardiomyocytes, and hypo-active or chronically hibernating myocardium with microvascular disturbances due to microthrombi and decreased capillary density. When bulk flow is successfully reconstituted by CABG or PTCA, the gradual recovery of microcirculation is considered as decisive for the recovery of mechanical function of surviving post-stenotic myocardium. Traditionally, neovascularization of disturbed microcirculation was considered to result exclusively from the proliferation, migration, and remodeling of fully differentiated endothelial cells (ECs) derived from pre-existing blood vessels. Recently, however, it was demonstrated that circulating, bone marrow-derived endothelial progenitor cells (EPCs) may home to sites of postnatal neovascularization and differentiate into ECs in situ, which is called “vasculogenesis”. Vascular trauma, as it occurs during surgical procedures, or inflammation leads to a cascade of events that result in the chemoattraction of inflammatory cells or other cell types to the site of injury. These blood-borne cells produce pro-angiogenic factors that, in turn, attract other cell types such as circulating EPCs. Systemic inflammatory responses have been described after cardiac surgery with cardiopulmonary bypass (CPB). Contact of the blood components with the artificial surface of the extracorporeal circuit, ischemia-reperfusion injury, endotoxemia, and operative trauma are possible causes for this phenomenon. Trauma has been considered as the critical stimulus for the mobilization of EPCs and proangiogenic vascular endothelial growth factor (VEGF) during CABG. It has been speculated that this mobilization may contribute to the revascularization of injured tissue, which would be of great clinical relevance for a successful outcome of CABG. Presently, there is a strong trend to perform CABG in patients of advanced age. However, experimental data indicate impaired neoangiogenesis in ischemic tissues and impaired re-endothelialization of vascular lesions as a function of advanced age. The mechanisms for this age-dependent impairment of vascular repair are largely unknown. Therefore, we analyzed the influence of age on CABG-induced mobilization of EPCs and cytochemokines with angiogenesis-modulating potential in a cohort of consecutive patients with stable coronary artery disease (CAD) scheduled for elective CABG. Probably, several types of endothelial precursor or progenitor cells have angiogenic potential after homing into traumatic tissue. Therefore, we used two phenotypic markers (CD34 and AC133 or CD133), which are expressed in all EPC types, but in the case of AC133, not in differentiated ECs. This was done to exclude from our analysis any mature or dying ECs with doubtful angiogenic capacity, potentially released from damaged vessels in old patients. In this analysis, we demonstrate that the preoperative number of circulating EPCs in patients with stable CAD is reduced with increasing age, together with decreased plasma VEGF levels. During CABG, mobilization of circulating EPCs could be detected in all patients, but this mobilization remained on a persistently lower level in the older patient group, suggesting that the responsiveness for mobilization of EPCs is impaired with age. Optimized strategies for ex-vivo expansion of those cells might be especially required in the elderly, if transplantation of these cells into poststenotic tissue will develop as a future co-therapy to existing interventions of revascularization.

This study demonstrated that the basal number of circulating EPCs in patients with stable CAD is decreased with increasing age. Furthermore, plasma VEGF levels are reduced with increasing age. This age-associated decrease could not be explained by higher prevalences of other risk factors, such as male gender, diabetes mellitus, hypertension, or hyperlipoproteinemia at older ages nor by any differences in left ventricular function or New York Heart Association classes. The operative trauma of complex cardiac surgery with CPB induced a mobilization in EPCs/ lymphocytes and EPCs/blood in all patients, but this mobilization remained on a persistently lower level in the older patient group, which could not be explained by any differences in the operative procedure (time on CPB, cross-clamping time, or number of grafts) or in the operation-induced increase in cytochemokines with a reported potency for modulation of angiogenesis (IL-6, IL-8, and IL-10). Similar age-associated losses in the number of circulating endothelial-related progenitor cells in patients undergoing CABG have not been reported so far. In 45 male subjects without a history of cardiovascular disease, the Framingham risk score and impairment of endothelium-mediated, flow-dependent brachial artery dilation were strong predictors of depressed numbers in circulating progenitor cells with colony-forming capacity. In a mixed group of healthy probands and CAD patients, Vasa et al. reported age-associated losses in circulating cells positive for CD34_ and KDR_, which may include progenitor cells and mobilized ECs. In their cohort, smoking was a strong predictor of lowered values in CD34_/KDR_ cells, independent of age. In the patients, self-reported smoking status, which is notoriously unreliable before cardiac surgery, could not be verified by interrogations of spouses or relatives. This may explain why we could not detect an effect of smoking on circulating EPCs. The reasons for the age-associated losses in circulating EPCs remain unknown at present. In this study, there was an age-independent correlation of circulating EPCs with plasma VEGF levels. Circulating or transplanted EPCs contribute to post-ischemic neovascularization in animal experiments and patients, and angiogenic factors like VEGF and PlGF are involved in this neovascularization. In animals, advanced age is associated with attenuated post-ischemic neovascularization and attenuated local induction of VEGF. Similarly, arterial re-endothelialization after vascular trauma is attenuated in old animals in which trauma-induced local VEGF expression is lower and local VEGF supplementation rescues vascular healing. Experimental elevation of plasma VEGF in mice by inoculation with adenoviral vectors induced rapid mobilization of endothelial precursor cells. Therefore, it is tempting to propose that lowered VEGF levels in the elderly patients are the reason for lowered circulating EPCs. However, this causality remains to be proven for basal steady-state levels, and the cause of depressed circulating VEGF levels in elderly patients remains unknown. In experimental studies, hypoxia-inducible factor-1 stabilization by hypoxia, which mediates hypoxic VEGF expression, is attenuated in cells from old animals. This might be relevant for the attenuated and retarded CABG-induced activation of plasma VEGF in older patients. However, this may be less relevant for the age-associated lowering in basal VEGF levels before surgery. Local and systemic inflammation by vascular trauma is considered an important contributor of post-ischemic neovascularization. In the patients, the operative trauma resulted in a substantial mobilization of cytochemokines with angiogenesis-modulating potential, except for IL-18 and PlGF. These observations are in agreement with previous reports. Although none of these activated factors could be directly correlated with the individual increase in EPCs during and after the operation in the patients, it is reasonable to assume that the complex spectrum of inflammatory activation is contributing to the mobilization of surgery-induced EPCs. Similar conclusions have been derived from observations on transient mobilization of KDR_/AC133_ cells in patients after burns or CABG. The kinetics of mobilization in that study differed somewhat from our observations, but the two studies are not directly comparable owing to differences in progenitor cell analysis. It is remarkable that the substantial inflammatory activation during surgery in our study could not abolish age-associated differences in EPC levels. The decline in the fraction of lymphocytes/leukocytes after CPB down to one-quarter that of the baseline value at 12 h after CPB most likely reflects substantial homing of lymphocytes into tissues in response to the systemic inflammatory activation induced by CPB. Homing must also contribute to the decline of circulating EPCs/ blood during this time. Therefore, circulating EPC levels underestimate the amount of EPC mobilization. However, quantification of lymphocyte or EPC homing could not be obtained in our patients. Application of different populations of EPCs or other mononuclear bone marrow cells improves postischemic organ function and microcirculation in animals and patients. However, it is not clear whether the surgery-induced mobilization of EPCs is sufficient for such a contribution. Furthermore, it is unclear whether the EPCs in elderly patients have the same angiogenic potential compared with those of younger patients. The EPCs collected from the circulation can be amplified in vitro. The co-application of amplified EPCs, together with native artery recanalization or bypass grafting, probably will develop as a therapeutic option in the future. The experimental data suggested that such co-therapy is especially desirable in elderly patients. The data suggested that mobilization of such cells for therapeutic application might be more difficult with an increasing age of patients. The inflammatory activation by complex CABG does not offset this age-associated lowering. Therefore, further studies are required for a better understanding of optimized strategies for recruitment, ex-vivo expansion, and retransplantation strategies involving EPCs in aging patients.

Abbreviations and Acronyms:

APC _ allophycocyanin

CABG _ coronary artery bypass grafting

CAD _ coronary artery disease

CPB _ cardiopulmonary bypass

EC _ endothelial cell

EPC _ endothelial progenitor cell

KDR _ kinase insert domain containing receptor

IL _ interleukin

PlGF _ placental growth factor

PTCA _ percutaneous transluminal coronary angioplasty

VEGF _ vascular endothelial growth factor

Source reference:

http://www.sciencedirect.com/science/article/pii/S0735109703012725

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