Requiem for Palliative Cardiology: The Voice of Dr. Esselstyn on Plant-Based Nutrition

February 2, 2014 by 2012pharmaceutical

Requiem for Palliative Cardiology: The Voice of Dr. Esselstyn on Plant-Based Nutrition

Reporter: Aviva Lev-Ari, PhD, RN

 

SELECTED ARTICLES BY DR. ESSELSTYN

Articles on the Arrest and Reversal Study: Is the Present Therapy for Coronary Artery Disease the Radical Mastectomyof the Twenty-First Century? A Strategy to Arrest and Reverse Coronary Artery Disease: A 5 -Year Longitudinal Study of a Single Physician’s Practice Esselstyn CB Jr. et al: The Journal of Family Practice 1995 December; 41(6): 560-68 Updating a 12 -Year Experience With Arrest and Reversal Therapy for Coronary Heart Disease (An Overdue Requiem for Palliative Cardiology) Esselstyn CB Jr. The Am J of Cardiology 1999 August 1; 84:339-341 Resolving the Coronary Artery Disease Epidemic through Plant-Based Nutrition (with photos of disease reversal) Esselstyn CB Jr: Preventive Cardiology 2001;4: 171-177 Patient Profiles In Cholesterol Lowering, Moderation Kills Esselstyn CB Jr. Cleve Clinic J of Med 2000 August; 67 (8): 560-564 Selected Articles: Beyond Surgery Presidential Address Esselstyn CB Jr. Surgery Dec 1991; 110(6): 923-27 More Than Coronary Artery Disease  Esselstyn CB Jr. : The Am J of Cardiology 1998 November 26; 82 (10B):5T-9T Changing the Treatment Paradigm for Coronary Artery Disease Esselstyn CB Jr.: The Am J of Cardiology 1998 November 26; 82(10B): 1T-4T Reflections and News: How to Keep David Letterman (and yourself) Off the Operating Table A Revolution to Restore America’s Health Huffington Post Interview with Dr. Esselstyn The Collapse of Cardiology: A Time to Rejoice? Olympic Reflections 50 Years Later Plant-based Nutrition News and Results Sample Recipes Video: Becoming Heart Attack Proof (62 minute presentation) For more video presentations, visit the MEDIA PAGE

SOURCE

http://www.heartattackproof.com/articles.htm

EXCERPT from
PREVENT AND REVERSE HEART DISEASE 

by Caldwell B. Esselstyn, Jr., MD

Chapter One
Eating to Live

I believe that coronary artery disease is preventable, and that even after it is underway, its progress can be stopped, its insidious effects reversed. I believe, and my work over the past twenty years has demonstrated, that all this can be accomplished without expensive mechanical intervention and with minimal use of drugs. The key lies in nutrition—specifically, in abandoning the toxic American diet and maintaining cholesterol levels well below those historically recommended by health policy experts.

The bottom line of the nutritional program I recommend is that it contains not a single item of any food known to cause or promote the development of vascular disease. I often ask patients to compare their coronary artery disease to a house fire. Your house is on fire because eating the wrong foods has given you heart disease. You are spraying gasoline on the fire by continuing to eat the very same foods that caused the disease in the first place.

I don’t want my patients to pour a single thimbleful of gasoline on the fire. Stopping the gasoline puts out the fire. Reforming the way you eat will end the heart disease.

Here are the rules of my program in their simplest form:

• You may not eat anything with a mother or a face (no meat, poultry, or fish).

• You cannot eat dairy products.

• You must not consume oil of any kind—not a drop. (Yes, you devotees of the Mediterranean Diet, that includes olive oil, as I’ll explain in Chapter 10.)

• Generally, you cannot eat nuts or avocados.

You can eat a wonderful variety of delicious, nutrient-dense foods:

• All vegetables except avocado. Leafy green vegetables, root vegetables, veggies that are red, green, purple, orange, and yellowand everything in between

• All legumes—beans, peas, and lentils of all varieties.

• All whole grains and products, such as bread and pasta, that are made from them—as long as they do not contain added fats.

• All fruits.

It works. In the first continuous twelve-year study of the effects of nutrition in severely ill patients, which I will describe in this book, those who complied with my program achieved total arrest of clinical progression and significant selective reversal of coronary artery disease. In fully compliant patients, we have seen angina disappear in a few weeks and abnormal stress test results return to normal.

SOURCE

http://www.heartattackproof.com/excerpt.htm

Q&A with Caldwell B. Esselstyn, Jr., MD

Caldwell B. Esselstyn, Jr., MD, F.A.C.S.

Please note: If your question is about finding a doctor in your area who supports a plant-based diet, please see this link: How to Find a Plant-Based Doctor.

1. How is your approach to treating heart disease unique?

My program is a nutrition-based therapy that has been scientifically-proven to reverse heart disease. There is no other treatment plan backed by a study as long as the one I conducted, or a study that has produced such dramatic, visible results. Coronary angiograms (X-Rays) of the patients in my study show an actual reversal of the disease. To experience these benefits, my patients must stick to my plant-based diet program strictly, but the effects are more than worth the effort. For those that are very sick, it is the most effective treatment option–far less dangerous and more effective than invasive surgical procedures such as stents and bypass (except in acute emergencies), and much more effective than drugs alone. Traditional cardiology has relied on technology to ease the symptoms of heart disease, but has not addressed its causes. My approach is not another stop-gap solution, it prevents heart disease from occurring in those who don’t yet have the disease, and it heals the body and reverses the disease when symptoms are present.

Best of all, over time the benefits endure and continue to improve. I am always excited when I see arrest and reversal in patient after patient and their joy and relief when they are free of the disease that was destroying them.

2. What would you say to someone considering a stent or other surgical procedure or drug therapy, to treat their heart disease?

All heart patients who are not absolute emergencies should first have an aggressive opportunity at non surgical medical therapy. This is not just my opinion but that of expert cardiolgists from Boston, Hartford, Houston, Stanford, San Diego, Seattle and Cleveland. The difference in my case is that I advocate an aggressive plant based nutrition program to arrest and reverse the disease and to avoid all surgery. Drugs alone do not prevent heart attacks and stop symptoms of heart disease.

3. How do you encourage your patients to stay on the diet?

There is no question it is hard at first. And it is hardest eating out at friends’ houses. However, I am always impressed how well my patients do once they experience the relief of chest pain, weight loss, and the improved feeling of well being they have eating a plant-based diet. Then the motivation comes from within. It also helps that within 8-12 weeks of starting the program the fat receptor in the brain down regulates and they lose the craving for fat. And as they start feeling better and better, they know that they are the ones– not their physician or their surgeon–that have control over the disease. It is a powerful feeling!

4. Why does the diet eliminate oil entirely?

NO OIL! Not even olive oil, which goes against a lot of other advice out there about so-called good fats. The reality is that oils are extremely low in terms of nutritive value. They contain no fiber, no minerals and are 100% fat calories. And above all they contain saturated fat which immediately injures the endothelial lining of the arteries when eaten. It doesn’t matter whether it’s olive oil, corn oil, coconut il or any other kind , avoid ALL oil. This is so important I have detailed oil in Chapter 10.

5. Can you actually enjoy food on the program?

We LOVE our food. Our children and grandchildren love our food and the patients love the food. Everyone loves the food once they give it a try. It is all a matter of attitude–and you do need a positive attitude to get started and to understand that this new way of eating is the best thing you can do for your body. Then, the body will help you adjust. You actually begin to lose your physiologically-based craving for fat. Once that occurs, you can fully appreciate the natural taste of plant foods–the colorful tastes and textures are difficult to surpass.

6. Why should I change? My health is excellent.

No one escapes in the end–eventually the traditional western diet guarantees some form of disease in all of us. While it may not be heart disease at the moment, eventually it will be or hypertension, diabetes, stroke,obesity, gall stones, diverticulitis, rheumatoid arthritis, lupus, multiple sclerosis, or a greater likelihood of breast, prostate, colon, ovarian and uterine cancers. Even erectile dysfunction and dementia. The world famous Framingham Heart Study now approaching its 60th year looked at 1,000 people at age 50 who had normal blood pressure. They looked at the same group at age 70, and 90% now had high blood pressure. But there is something that you can do now to stop the cascading events that occur in the body and lead to disease. You can change your diet and begin safeguarding your health for the future.

More Commonly Asked Questions

Protein – Where do I get my protein / What protein drink is best? 
Extra protein powder and shakes are truly unnecessary and have the potential for harm if they contain animal protein. The protein available in a diet of whole grains, legumes and beans, and red, yellow and green vegetables is adequate to nourish even professional champion athletes such as the iron man, professional football, mixed marshal arts, track and field,

Calcium – Where do I get calcium?
Calcium supplementation is unnecessary. There is more than adequate calcium in a plant- based diet of whole grains, legumes and grains and especially the green leafy vegetables.

Vitamins – What Vitamins should I take?
Take Vitamin B-12. If eating copious amounts of leafy green vegetables, a multi vitamin is unnecessary. Have blood tested for Vitamin D level and supplement as appropriate to maintain blood level in the normal range.

Fish Oil – Should I take fish oil?
Fish oil is not essential. Fish get their omega 3 from plants. It is difficult to be deficient in Omega 3 if eating 1-2 tablespoons of flax seed meal or chia seeds and green leafy vegetables at several meals. There is also research that suggests that those on plant based nutrition become highly efficient in their own manufacture of omega 3. Patients on fish oil are also at increased risk for bleeding.

Flax Seed Oil/ Flax Seed Meal – What about flax seed oil?
Flax seed meal is well tolerated and supplies a bonus of omega 3 using 1 or 2 tablespoons on cereal daily. Avoid flax seed oil.

Olive oil, canola oil, coconut oil, Sunflower oil, soybean oil, peanut oil, any oil –
Which oil is best?
Avoid oils. They injure the endothelium, the innermost lining of the artery, and that injury is the gateway to vascular disease. All oil is also empty calories.

Lotions with oil – Is it all right to use lotions with oil on my skin?
It is fine to use lotions with oil on your skin.

Omega 3 – How do I get my Omega 3’s?
Omega 3’s are essential fatty acids supplied in adequate amounts in people consuming plant based nutrition with plenty of green leafy vegetables. However 1-2 tablespoons of flax seed meal or chia seeds daily is perfectly accepted.

Family history – I have a bad family history? Does it matter?
Our data indicates even those with strong family history when eating plant based are protected from vascular disease. Family history loads the gun but lifestyle pulls the trigger.

Nuts – What about nuts? I hear so many different opinions.
My preference is no nuts for heart disease patients. That also eliminates peanuts and peanut butter even though peanuts are officially a legume. For those with established heart disease to add more saturated fat that is in nuts is inappropriate. For people with no heart disease who want to eat nuts and avocado and are able to achieve a cholesterol of 150 and LDL of 80 or under without cholesterol lowering drugs, some nuts and avocado are acceptable. No nuts for heart disease patients, includes peanuts and peanut butter, even though peanuts are officially a legume. Chestnuts are the one nut, very low in fat, it is ok to eat.

Seeds (sunflower, pumpkin, sesame, etc.) Are seeds ok to eat?
1 -2 tablespoons of ground flax seeds or chia seeds daily for omega 3 are appropriate for everyone to eat including heart patients if they wish. Some seeds baked in bread or crackers is acceptable. Just don’t eat handfuls.

Coconut water – Is it all right to drink coconut water?
Coconut water is 8% saturated fat (If the fat is less than .5 per serving it does not have to be listed on the label) and about 50% sugar. So save your money and don’t use it.

Prostate cancer- Does plant based eating help prostate cancer?
Prostate cancer is greatly lessoned by plant- based nutrition as best exemplified by the 1958 report confirming by autopsy 18 deaths in the entire nation of Japan.

Egg whites, fat free milk, yogurt – So What is wrong with egg whites, fat free yogurt, skim milk?
Egg whites, fat free milk and yogurt are ALL animal protein, and animal protein injures the lining of the arteries. Do not eat.

Cholesterol Number fluctuation – Why do my cholesterol numbers fluctuate? 
Fluctuation of cholesterol is normal. It is nice to have it fluctuating in a range that would indicate you are unlikely to have cardio vascular problems.

Losing weight – What can I do to stop losing too much weight?
If you are losing too much weight, EAT MORE calories. Increase portion size. Eat snacks. Eat more whole grains and beans.

Tired, no energy – Why am I tired and have no energy since eating plant-based? 
If you feel tired and lacking in energy, be sure you are eating enough calories. Also exercise because you need to use energy to make energy. Depression also contributes to lack of energy. But first of all eat more.

Not losing weight – Why haven’t I lost weight/ Why have I stopped losing weight?
If not losing enough weight, eliminate flour products like bread, pasta and bagels. Instead, eat whole grains like rice, quinoa, barley and farro, etc. Reduce portion size. Increase leafy green vegetables and exercise.

Triglycerides- Why did my triglycerides go up?
If your triglycerides are high, cut back on simple carbohydrates, which would include alcohol, wine, beer, white flour products, sugars including dried fruit, honey maple syrup, molasses, rich desserts, fruit juice or an excess of fruit,

HDL- My doctor is so concerned because my HDL has gone down
It is not uncommon for HDL to fall when consuming plant based nutrition. Do not be alarmed. The capacity of HDL to do its job has been shown recently by scientific research that there is no relationship between the capacity of the HDL molecule to function optimally and its blood level. Recent research has confirmed that the HDL molecule can be injured and weakened when one is ingesting a pro inflammatory western diet and conversely it appears despite a lower than normal level to be optimized by anti inflammatory plant based-nutrition.

LDL – Where should my LDL be?
LDL is the bad cholesterol. The closer it can be to 80-85, the better. However, if one is unable to take statin drugs and eating plant-based nutrition, and the LDL won’t go lower than 95-105, it would appear that they will still be fine. The lesson we learned from the Tarahumara Indians, who never have cardiovascular disease, is that the most key protective element is not so much the pure LDL number as is knowing that nothing ever is eaten which is a building block of vascular disease or can injure endothelium.

Statins – Should I take statins or not?
Statins are not the reason that cultures such as the Tarhumara and the Papua Highlanders do not have cardiovascular disease. Statins appear to have minimal if any benefit in primary prevention but are of some help in slowing disease progression for those who already have an established diagnosis of cardiovascular disease. Clearly some of our most profound successes in arresting and reversing disease were with patients who either refused or were incapable of taking statins. Nothing is as powerful for the prevention of cardiovascular disease as plant based nutrition.

Coumadin – Can I eat leafy greens when I am on Coumadin?
Coumadin (Warfarin) is an anti clotting drug shown to have significant benefit in protecting people with atrial fibrillation from having a stroke. Can patients on Coumadin eat all the green leafy vegetables with vitamin k, which may shorten their clotting time? The answer most emphatically is YES! Merely inform the physician who is monitoring the Coumadin and clotting time that you are regularly going to be eating copious amounts of healthy green leafy vegetables. He/she will appropriately adjust the Coumadin dose.

Juicing- Is it all right to juice?
Do not juice. You lose all the fiber and its benefits.

Fruit juice – What about fruit juice?
Drinking fruit juice is like pouring the sugar bowl down your throat. It is fine to eat the whole fruit. Do not drink the juice.

Smoothies – How about smoothies? I love them! 
Avoid smoothies. The fiber is so finely pureed that its helpful properties are potentially compromised. The sugar is separated from the fiber of the fruit, bypasses salivary digestion and results in a surge of glucose. The accompanying fructose contributes to inflammation, hypertension and endothelial injury.

A Fib- Will plant nutrition work for A Fib?
While A Fib is largely independent of nutrition, and is a heart rhythm abnormality, there are some subset of cases which are presumably related to less than optimal heart circulation. While it would be totally inappropriate for me to suggest plant – based nutrition would cure atrial fibrillation, the many ancillary benefits would indicate plant based nutrition would be of value.

Calcium score- Is a calcium score helpful?
With cardiac CT you get a big hit of radiation. If you have been eating the typical American diet, you already have heart disease as autopsy studies have shown.

SOURCE

http://www.heartattackproof.com/qanda.htm

Caldwell B. Esselstyn, Jr Speaking Schedule 2014

Engine 2 “Farms 2 Forks” Immersions – A chance to spend two days with Dr. Esselstyn Join Dr. Esselstyn, his wife Ann, his son Rip, and his daughter Jane at the Engine 2/Forks Over Knives’/”Farms 2 Forks” weekend retreats!  For three days, you can learn the medical, nutritional, psychological, and practical tools that you and your family can turn into a lifetime of good health and enjoyable food.   Joining the Esselstyn’s at events will be nutrition expert, Michael Greger MD, and Dr. Doug Lisle, food psychologist and author of “The Pleasure Trap”.  Special guest speakers will include Dr. Neal Barnard, Dr. John McDougall, and T. Colin Campbell. For more information or to register, visit the event website at www.farms2forks.com. Wednesday, February 5, 2014 Columbia Presbyterian Grand Rounds Myrna Daniels Auditorium, 1st floor Vivian & Seymour Milstein Family Heart Center 173 Fort Washington Ave New York City 12:00pm-1:00pm Open to the public Tuesday, February 11, 2014 Essy Cooper Clinic Dallas, Texas 4:00-5:00 for details contact Christine Dicken at 972-560-2667 Tuesday, February 18, 2014 E&A Twinsberg Library Twinsberg, Ohio 7:00 pm Friday, February 21- Sunday, 23, 2014 E&A McDougal Advanced Study Weekend Santa Rosa, California 800-941-7111 for details February 28th — March 2nd, 2014 E&A Engine 2 Phoenix Retreat Hyatt Regency Phoenix 122 North Second Street Phoenix, AZ 85004 Engine 2 and Forks Over Knives are kicking off the 2014 series in beautiful, sunny Phoenix, and are sure the warm, inviting February weather will bring people from across the country for a weekend of inspiration and change in the desert. We will be gathering at the Hyatt Regency, right in the middle of cosmopolitan downtown Phoenix, with easy access to the airport and everything that the city has to offer. With the Esselstyn family leading the way, we will tackle a myriad of topics designed to increase your plant-based knowledge, and send you home overflowing with information for yourself, your loved ones, your coworkers, and anyone else you encounter! For details: www.engine2diet.com Tuesday, March 11, 2014 Essy Cleveland Clinic Cleveland, Ohio Lerner NA5-08 12:00-1:00 Wednesday, March 19, 2014 Essy Cleveland Clinic Pediatric Grand Rounds A 11 800 conference room 4:00 pm Thursday, March 27, 2014 Essy Drury University Springfield, Missouri Health Care Forum Details:417-880-5001 Friday, April, 18, 2014 Essy Mayo Clinic Rochester, Minnesota 7:30 -8:30 am April 25th — April 27th, E&A Engine 2 Retreat Portland 2014 Hilton Portland & Executive Tower 921 Sixth Avenue Portland, OR 97204 If you haven’t been to Portland, Oregon, you are really missing out. Wait, here’s your chance! Engine 2 and Forks Over Knives are thrilled to bring an Engine 2 Retreat weekend to one of the most beautiful, green, and spectacular cities is America. We are setting up shop right smack in the middle of downtown Portland, which lies in the shadow of the majestic and awe-inspiring Mount Hood. Our location is an easy walking distance from all of the coffee shops, eclectic stores, and vibrant culture that this most “European” of American cities has to offer. For details: www.engine2diet.com Saturday, May 3, 2014 Essy Iowa Osteopathic Association DeMoine, Iowa Embassy Suite Hotel 9:00 Thursday, May, 15- Sunday, May 17 E&A Gold Symposium Boulder, Colorado Details: 303-625-2098 Sunday, May 18- Thursday May 22 E&A Engine 2 Retreat Sedona Sedona Hotel 3500 E. Bill Gray Road Sedona, AZ 86336 Rip Esselstyn invites you to join Engine 2 and Whole Foods Market team members in Sedona, Arizona in 2014 for a weeklong immersion intensive retreat, scheduled for May 17th — 23rd at the Sedona Mago Retreat Center. Featuring the all-star cast from our sold-out Engine 2 Retreat Weekends, this 7-day/6-night life-changing week will give you an in-depth medical & nutritional education about why & how to adopt a plant-strong lifestyle. In addition, the curriculum delves deeply into the psychological and practical methods & practices for successfully implementing sustainable lifestyle changes, with multiple lectures and breakout sessions led by esteemed doctor Caldwell B. Esselstyn, famed nutritionist Michael Greger, and renowned psychologist Doug Lisle. For details: www.engine2diet.com June 27th – 29th, 2014 E&A Engine 2 Retreat Chicago Double Tree Chicago – Oak Brook 1909 Spring Rd Oak Brook, IL 60523 Engine 2 and Forks Over Knives are thrilled to return to the Windy City for another wonderful inspiring and motivating plant-strong Engine 2 Retreat. We can’t get enough of the warm & welcoming midwestern hospitality, and we enjoy returning here each year. This year we’ll be just west of downtown Chicago in the wonderful suburb of Oak Brook, IL. With Rip as your host, we will tackle a myriad of topics designed to increase your plant-based knowledge. More For details: engine2diet.com August 16th – 17th, 2014 The Ultimate Weekend Experience: Plant-Stock E&A Engine 2 Retreat Claverack Esselstyn Family Farm 56 Willowdale Farms Claverack, NY 12513 On the Esselstyn family’s idyllic 400-acre farm in the beautiful Catskills, “Plant-Stock” brings you the ultimate plant-strong experience. We have lined up a rockstar roster to motivate and inspire you to take back your health. The weekend will feature all the plant-strong heavyweights, including Dr. Caldwell B. Esselstyn, Jr., T. Colin Campbell, Michael Moss, and many more special guests to be announced throughout the coming year. A rousing success last year, the event created a whole network of plant-strong ambassadors. We hope you will join us, take this information home with you, and put it into practice with your family, friends, and community! Be the change. For details: engine2diet.com Sunday, September 8 E&A Aspen Valley Hospital Cardiac Rehab opening Aspen, Colorado 1:00-4:00 Friday, September 12 – Sunday September 14, 2014 E&A Engine 2 Immersion Austin, Texas Details:engine2.com Thursday, September 18 – Saturday September 20 Essy Plant Based National Health Conference San Diego, California October 12th – 18th, 2014 E&A E2 Weeklong Immersion Intensive: Sedona, Arizona Sedona Hotel 3500 E. Bill Gray Road Sedona, AZ 86336 Rip Esselstyn invites you to join Engine 2 and Whole Foods Market team members in Sedona, Arizona in 2014 for a weeklong immersion intensive retreat, scheduled for October 12th – 18th at the Sedona Mago Retreat Center. Featuring the all-star cast from our sold-out Engine 2 Retreat Weekends, this 7-day/6-night life-changing week will give you an in-depth medical & nutritional education about why & how to adopt a plant-strong lifestyle. In addition, the curriculum delves deeply into the psychological and practical methods & practices for successfully implementing sustainable lifestyle changes, with multiple lectures and breakout sessions led by esteemed doctor Caldwell B. Esselstyn, Jr.famed nutritionist Michael Greger, and renowned psychologist Doug Lisle. For details: engine2diet.com Wednesday, October 23 – Sunday, October 26 E&A Lithuania  SOURCE http://www.heartattackproof.com/speaking_dates.htm

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Posted in Atherogenic Processes & Pathology, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Human Immune System in Health and in Disease, Nutrition, Nutritional Supplements: Atherogenesis, lipid metabolism, Origins of Cardiovascular Disease, Personalized and Precision Medicine & Genomic Research, Population Health Management, Nutrition and Phytochemistry | 3 Comments »

Testosterone Therapy for Idiopathic Hypogonadotrophic Hypogonadism has Beneficial and Deleterious Effects on Cardiovascular Risk Factors

January 30, 2014 by 2012pharmaceutical

Testosterone Therapy for Idiopathic Hypogonadotrophic Hypogonadism has Beneficial and Deleterious Effects on Cardiovascular Risk Factors

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 5/20/2014

New Studies Highlight Benefits, Risks of Testosterone Therapy

New data also indicate who may benefit most from treatment

PR Newswire

ORLANDO, Fla., May 18, 2014 /PRNewswire-USNewswire/ —

Three new studies examining the predictors, effects and durability of testosterone therapy on men will be presented to reporters at the 109^th Annual Scientific Meeting of the American Urological Association (AUA) during a special press conference in the Orange County Convention Center,Orlando, FL on Sunday, May 18 at 2:00 p.m. ET.

Testosterone, a hormone produced primarily in the testicles, helps maintain a man’s:

• Bone density
• Fat distribution
• Muscle strength and mass
• Red blood cell production
• Sex drive
• Sperm production

 

Testosterone therapy is used to treat men with clinically diagnosed testosterone deficiency, also known as hypogonadism. While hypogonadism can be associated with fatigue, erectile dysfunction, decreased muscle mass and even infertility, these symptoms may not always be related to low levels of this hormone. Men with these symptoms should consult with their physicians and undergo blood tests prior to starting testosterone replacement therapy.

Study Details 

Exercise Improves the Effect of Testosterone Replacement Therapy and the Durability of Response After Cessation of Treatment (#MP48-02): Exercise may help sustain the positive effects of testosterone therapy even after treatment ends, according to a new study from Ansan Hospital and Seoul Paik Hospital in Korea. Fifty patients with late-onset hypogonadism and similarly sedentary lifestyles were enrolled and placed into one of two random groups prior to starting the 20-week study, which included 12 weeks of Testosterone Replacement Therapy (TRT) and eight weeks of follow-up without therapy. One group was offered a supervised physical activity program concurrent with TRT therapy for the duration of the study while the other received TRT alone. Throughout the study, improvements were seen in both groups, with total serum testosterone levels significantly increased at 12 weeks; however, greater increases were seen in the exercise group. This group also showed more sustained improvements in symptoms following the cessation of TRT. In particular, 72.2 percent of patients in the exercise group reported improvements in erectile function at the conclusion of the study, compared to 45.5 percent of the non-exercise group, leading researchers to conclude, the combination of exercise and TRT offers significant improvements in testosterone levels and late-onset hypogonadism symptoms, which can be well sustained with continuous exercise even after the cessation of TRT.

Long-term Testosterone Treatment Leads to Progressive Weight Loss and Waist Size Reduction in Hypogonadal Men (#MP48-01): Obesity and other metabolic disorders may be related to low levels of testosterone and restoring hormone levels may improve these conditions in some men, according to a new study from researchers in Germany and the United States. Using data from a prospective registry of 261 men (ages 32 to 84) with low testosterone (<12nmol/L), researchers examined 164 men for five years of testosterone therapy. After five years of follow up, the men had experienced statistically significant weight loss (mean weight decrease from 104.23 kg to 92.49 kg), decreases in body mass index (average 33.17 to 29.44) and waist circumference (average 108.61 to 99.03) as well as changes in total cholesterol, glucose and blood pressure levels.

Predictors of Poor Response to Transdermal Testosterone Therapy in Men with Metabolic Syndrome (#MP48-04): A new study from Weill Cornell Medical College in New York indicates men with diabetes and obesity may have less success with TRT than men without these conditions. Researchers reviewed 58 patients, with 32 having a BMI of less than 30 (non-obese) and 26 with a BMI greater than 30 (obese). All 58 patients were of similar age, with similar baseline hormone levels. At the end of the study period, 81 percent of non-obese men had achieved normal testosterone levels, compared to 52 percent of obese men (P=0.03). Total testosterone levels were 81 percent and 54 percent, respectively, suggesting that metabolic conditions may impact the efficacy of TRT.

“In the right patients, TRT can significantly improve symptoms,” said Tobias S. Köhler, MD, MPH, FACS; session moderator and associate professor & residency program director with Southern Illinois University School of Medicine. “However, as these studies show, not all men may be good candidates for this therapy. It”s extremely important for men to talk with their doctors about the benefits and risks of this therapy.”

About the American Urological Association: The 109^th Annual Meeting of the American Urological Association takes place May 16 – 21 at the Orange County Convection Center in Orlando, FL.

Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 20,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.

Contact:
Christine Frey, AUA
410-999-7091, cfrey@AUAnet.org

SOURCE American Urological Association

SOURCE

http://www.pharmafocusasia.com/news/news_archives.asp?NewsID=48624&title=New-Studies-Highlight-Benefits-Risks-of-Testosterone-Therapy

 

 

 

 

 

UPDATED on 4/16/2014

The Risks of Taking Testosterone – How Men’s Hormone Supplements Threaten Heart Health

 It’s not uncommon for middle-aged men to become concerned about low testosterone levels as they age, and advertisements that play on this fear to market hormone products are commonplace. The ads may be effective, however, since prescriptions for testosterone therapy more than tripled among men age 40 and up from 2001 to 2011.

As the trend to turn to testosterone supplements continues to grow, the medical community has begun to raise concerns about risks that have emerged in connection with taking the hormones.

For example, the risk of having a nonfatal heart attack more than doubled for men age 65 or older during the three months after starting a testosterone prescription, according to a recent study published in the January 2014 journal PLOS One (Public Library of Science). The same study found that men younger than 65 who took testosterone for the same time period only experienced a higher risk for heart attack if they had a prior history of heart disease. The research reviewed data from 55,593 men who filled their first prescription for testosterone, comparing the 90 days after the prescription was filled with data from the prior year, in which they were not taking the hormone at all.

“This study found that risk levels dropped down to normal levels for men who stopped taking the hormone after 90 days,” says Michael C. Gavin, MD (right), a cardiologist in the CardioVascular Institute at BIDMC. “The same study found no association with increased heart risk among men taking drugs like Viagra, which do not contain any testosterone.”

A second study found that taking testosterone caused a 30 percent increase in the risk for heart attack, stroke and death among a group of veterans with a history of heart disease. This clinical trial, published in the Journal of the American Medical Association in 2013, was halted prematurely to the emerging concerns about testosterone safety.

What Causes a Decrease in Testosterone?

“Testosterone levels naturally begin to drop after the age of 30,” says Gavin. “The symptoms are what many men begin to feel when they reach their 40s, 50s or older, which may include a drop in muscle mass, energy, and interest or performance in sex. The trouble is that these symptoms may also be connected to metabolic syndrome, which involves a number of conditions — excess body weight around the waist, high blood pressure or blood sugar, and abnormal cholesterol levels — that also increase risk of heart disease.”

The connection between loss of testosterone and abdominal girth is no accident.

“Fat cells are hormonally active and release or metabolize compounds, including estrogen-like hormones,” says Gavin. “That’s why we often see a connection with abdominal fat and breast tissue, which can then lower the brain’s ability to produce natural testosterone. Physiology is very complex, and the associations between excess weight and hormonal issues are clear, and seen over and over again in patients.”

The Need for Testing and Weighing the Risks

About one-quarter of men who receive testosterone prescriptions are not tested for low testosterone, according to Gavin, who stresses that a lab test must confirm that the patient’s hormone level has slumped to an abnormal number before a prescription is considered.

“While there is certainly a connection between aging and low testosterone, and some men with low-T could benefit from hormone therapy, the risks need to be carefully considered first,” he says.

Gavin explains that research has found that the use of synthetic testosterone in a lab setting decreases HDL, or healthy, cholesterol levels, and increases red blood cell counts, which leads to an increased risk for blood clots — often the cause for heart attacks and stroke.

The Final Analysis

As a cardiologist, Gavin recommends lifestyle interventions as the first action to combat low testosterone.

“There’s no doubt about beneficial effects of exercise and weight loss on risk factors for low testosterone,” he says. “Men can begin lifting light weights to increase muscle mass and follow a healthy diet to promote weight loss.

“For those people who still feel unwell and show low testosterone in lab tests along with no signs for cardiovascular disease, it’s reasonable to consider hormone therapy. But biochemical evidence is needed, and I still recommend trying lifestyle changes first,” Gavin adds. “And, for older men or those with cardiovascular risk factors, I would exercise extreme caution in balancing risks with benefits. The numbers in the studies are alarming and should not be taken lightly.”

Above content provided by the CardioVascular Institute at Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.

Posted April 2014

more information:

http://www.bidmc.org/Centers-and-Departments/Departments/Cardiovascular-Institute/CVI-Newsletter/Testosterone.aspx#sthash.Hfv6UZXW.dpuf

REFERENCES

Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805

Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels

http://jama.jamanetwork.com/article.aspx?articleid=1764051

 

 

SOURCE

http://www.bidmc.org/Centers-and-Departments/Departments/Cardiovascular-Institute/CVI-Newsletter/Testosterone.aspx

 

Several Research Findings are presented for the exposition of the Beneficial and the Deleterious Effects of Testosterone Therapy on Cardiovascular Risk Factors

Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels

Rebecca Vigen, MD, MSCS¹; Colin I. O’Donnell, MS^2,3; Anna E. Barón, PhD^2,3; Gary K. Grunwald, PhD^2,3; Thomas M. Maddox, MD, MSc^2,3,4; Steven M. Bradley, MD, MPH^2,3,4; Al Barqawi, MD³; Glenn Woning, MD³; Margaret E. Wierman, MD^2,3; Mary E. Plomondon, PhD^2,3,4; John S. Rumsfeld, MD, PhD^2,3,4; P. Michael Ho, MD, PhD^2,3,4

[+] Author Affiliations

JAMA. 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386.

ABSTRACT

Importance  Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown. A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety.

Objectives  To assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease.

Design, Setting, and Patients  A retrospective national cohort study of men with low testosterone levels (<300 ng/dL) who underwent coronary angiography in the Veterans Affairs (VA) system between 2005 and 2011.

Main Outcomes and Measures  Primary outcome was a composite of all-cause mortality, MI, and ischemic stroke.

Results  Of the 8709 men with a total testosterone level lower than 300 ng/dL, 1223 patients started testosterone therapy after a median of 531 days following coronary angiography. Of the 1710 outcome events, 748 men died, 443 had MIs, and 519 had strokes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. At 3 years after coronary angiography, the Kaplan-Meier estimated cumulative percentages with events were 19.9% in the no testosterone therapy group vs 25.7% in the testosterone therapy group, with an absolute risk difference of 5.8% (95% CI, −1.4% to 13.1%). In Cox proportional hazards models adjusting for the presence of coronary artery disease, testosterone therapy use as a time-varying covariate was associated with increased risk of adverse outcomes (hazard ratio, 1.29; 95% CI, 1.04 to 1.58). There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease (test for interaction, P = .41).

Conclusions and Relevance  Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy.

SOURCE

http://jama.jamanetwork.com/article.aspx?articleid=1764051

Testosterone therapy doubles heart risk in older men

Liz Szabo, USA TODAY6:22 p.m. EST January 29, 2014

Taking testosterone therapy doubled the risk of heart attack among men over age 65 and nearly tripled the risk in younger men with a history of heart disease, a new study shows.

The report, which involved 56,000 men, is the latest in a series of studies raising concerns about the heart attack risk from testosterone therapy, whose popularity has ballooned in recent years. The study was published Wednesday in PLOS One.

Francisco Lopez-Jimenez, a cardiologist at the Mayo Clinic in Minnesota not involved in the new study, describes the heart risks posed by testosterone therapy as substantial.

“That’s equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol,” Lopez-Jimenez says.

Authors of the study, led by researchers at the University of California-Los Angeles and others, say doctors should discuss these risks with patients. Testosterone is often called the “male hormone” because it causes development of male sex organs, facial hair and other masculine features.

Doctors recommend testosterone therapy to treat hypogonadism, which causes abnormally low testosterone levels. Studies show that testosterone can improve sexual function, bone density, lean muscle mass and strength while lowering cholesterol and insulin resistance, a condition that increases the risk of diabetes.

Drug companies also have marketed testosterone directly to consumers, however, urging men to consider hormones to treat the symptoms of “low T,” which are said to include energy loss, mood changes and reduced sex drive.

Those ads appear to have been hugely successful.

Doctors wrote more than 5.3 million prescriptions for testosterone therapy in 2011, five times as many as in 2000, according to a November report in the Journal of the American Medical Association. The number of men taking testosterone tripled from 2001 to 2011, with the drugs now used by nearly 4% of men in their 60s, according to a separate study last year in JAMA Internal Medicine.

Yet only about half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% hadn’t even had their testosterone levels tested, according to the JAMA Internal Medicine study. The rest of patients had been diagnosed with other problems such as fatigue or sexual dysfunction.

A spokesman for AbbVie, which makes AndroGel, one of the most popular testosterone therapies, notes that studies also have found health benefits from the medications. A 2012 study linked testosterone with a lower risk of death. A 2013 study in the Journal of Clinical Practice found that men taking the therapy long-term had healthier cholesterol levels, blood sugar levels and blood pressure.

“We encourage discussion between physicians and patients that leads to proper diagnosis based on symptoms, lab tests and a patient’s other health needs,” says David Freundel, a spokesman for AbbVie.

Abraham Morgentaler, an associate clinical professor of urology at Harvard Medical School, says it’s possible that the men’s heart attacks in this study were caused by their underlying medical problems, not by testosterone. He notes that most heart attacks occurred in the first 90 days after a prescription was written. It’s unlikely that heart attacks could develop in such a short period of time, he says.

Cardiologist Steven Nissen says the Food and Drug Administration should require companies that sell testosterone therapy to conduct rigorous clinical trials examining the medication’s heart risks.

Nissen, chair of cardiovascular medicine at the Cleveland Clinic, notes that hormones have powerful and sometimes surprising effects throughout the body, not just on sexual organs. He cited hormone replacement therapy, which was once touted as a way to prevent heart disease in women but was later found to cause heart attacks, strokes and breast cancer. Prescribing testosterone therapy to thousands of men who may not really need it, he says, is “a “gigantic experiment, and I’m extremely concerned.”

SOURCE

http://www.usatoday.com/story/news/nation/2014/01/29/testosterone-heart-risks/4967795/

Testosterone Therapy May Raise Cardiovascular Risk

Testosterone therapy was associated with adverse cardiovascular (CV) outcomes in a large observational study. The findings raise questions about the potential safety of testosterone use in men, wrote Rebecca Vigen MD, and her colleagues in the Journal of the American Medical Association (2013;310:1829-1836).

VIEW VIDEO

http://www.renalandurologynews.com/testosterone-therapy-may-raise-cardiovascular-risk/article/319911/

Dr. Vigen’s group assessed the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and determined the effect of underlying coronary artery disease (CAD) on the relationship. The researchers conducted a retrospective national cohort study of men with low testosterone levels (less than 300 ng/dL) who had undergone coronary angiography in the Veterans Affairs health system from 2005 to 2011. Average follow-up was approximately 840 days (27.5 months).Of the 8,709 study subjects with low testosterone, 1,223 (14%) started testosterone therapy after a median of 531 days following coronary angiography. Those patients tended to be younger (mean age 61 years) than the testosterone non-users (mean age 64 years) and tended to have lower rates of congestive heart failure, renal failure, and other comorbidities.Approximately one of every five men not taking testosterone died and/or had a heart attack or a stroke, compared with approximately one out of four testosterone users. Testosterone therapy was associated with a 29% greater risk of these events.The absolute rate of events among the no-testosterone group versus the testosterone group was 10.1% versus 11.3% at one year post-angiography, 15.4% versus 18.5% at two years, and 19.9% versus 25.7% at three years, for an absolute risk difference of 5.8% at three years after angiography. Even after adjustments for the presence of CAD and other factors, testosterone therapy was associated with adverse outcomes—an effect that was consistent among men with and without CAD.The investigators noted some potential mechanisms through which testosterone therapy may increase CV risk. For example, other research has indicated that intramuscular testosterone can increase platelet aggregation, and that the testosterone metabolite dihydrotestosterone can promote atherosclerosis.Having pointed out potential limitations of their study, the investigators emphasized the need for more research, including randomized controlled trials, to properly characterize the risks of testosterone therapy in men with comorbidities.

From the December 2013 Issue of Renal And Urology News »

 

SOURCE

http://www.renalandurologynews.com/testosterone-therapy-may-raise-cardiovascular-risk/article/319911/

Testosterone and the heart

Testosterone is responsible for men’s deep voices, increased muscle mass, and strong bones. It also has crucial effects on male behavior, contributing to aggressiveness, and it is essential for the sex drive and normal sexual performance.

Although testosterone acts directly on many tissues, some of its least desirable effects don’t occur until it is converted into another male hormone, dihydrotestosterone (DHT). DHT acts on the skin, sometimes producing acne, and putting hair on the chest but often taking it off the scalp. DHT also stimulates the growth of prostate cells, producing normal growth in adolescence but contributing to benign prostatic hyperplasia (BPH).

But while testosterone’s effects on many organs are well established, research is challenging old assumptions about how the hormone affects a man’s heart, circulation, and metabolism.

Early worries

A direct association between testosterone and heart disease has never been established, but for many years, doctors have suspected that a link exists. The reasoning goes like this: men have much more testosterone than women, and they develop heart disease about 10 years before their female counterparts. Like other muscle cells, cardiac muscle cells have receptors that bind male hormones. Animals that are given testosterone develop enlarged hearts. Athletes who abuse testosterone and other androgenic steroids have a sharply increased risk of high blood pressure, heart attack, and stroke. And in high doses, testosterone can have a negative effect on cardiac risk factors, including HDL (“good”) cholesterol levels.

The fact that large amounts of testosterone harm the heart and metabolism doesn’t necessarily mean that physiological amounts are also harmful. In fact, research is challenging these old dogmas.

Complex relationships

It’s hard for scientists to study possible new risk factors for heart disease. One reason is that there are so many cardiac risk factors, including family history, age, gender, blood pressure, cholesterol, blood sugar, obesity, smoking, exercise, and personality.

It’s also hard for scientists to study testosterone. There is an exceptionally wide range of normal values. Healthy men can have testosterone levels between 270 and 1,070 nanograms per deciliter (ng/dL).

Heart disease and testosterone are mighty complex on their own, and studies that evaluate the two together are more complex still. Scientists who undertake these daunting investigations must account for all the things that influence heart disease and all the variables that affect testosterone.

With all these pitfalls, it’s not surprising that more research is needed to fill in all the blanks. Still, even if current information can’t tell us if testosterone can protect a man’s heart, it can dispel fear that physiologic levels of the hormone are toxic.

Testosterone and cardiac risk factors

In high doses, androgens tend to raise LDL (“bad”) cholesterol levels and lower HDL cholesterol levels. That’s one of the things that gave testosterone its bad reputation. But in other circumstances, the situation is very different. Men who receive androgen-deprivation therapy for prostate cancer drop their testosterone levels nearly to zero, and when that happens, their cholesterol levels rise. Even within the normal range, men with the lowest testosterone levels tend to have the highest cholesterol levels.

Diabetes is another important cardiac risk factor. Prostate cancer treatments that lower levels of testosterone produce insulin resistance and increase the risk of diabetes. Obesity increases the risk of both diabetes and heart disease. Men with low testosterone have more body fat and more of the abdominal fat that’s most harmful than men with higher hormone levels, but since obesity itself reduces testosterone, it’s not clear which is the cause and which the effect.

Peripheral artery disease (PAD) is an important form of atherosclerosis in its own right, and it also signals an increased risk for heart disease. A Swedish study of over 3,000 men with an average age of 75 linked low testosterone levels to an increased risk of PAD. At present, the hormone does not appear linked to hypertension or inflammatory markers.

Testosterone therapy and cardiovascular function

Low testosterone levels have been linked to various cardiac risk factors, but that doesn’t prove that low levels actually cause heart disease. Still, if testosterone therapy could help men with heart disease, it would bolster the argument that testosterone may be safe for the heart. Only a few small, short-term studies have been published to date, and the results offer mixed support for this theory.

Testosterone tinkering

As men age, it’s not just heart disease they need to worry about. They also begin to lose muscle mass and bone density; red blood cell counts sag; sexual ardor declines; mood, energy, and memory drift down; and body fat increases. In theory, at least, testosterone therapy might blunt or reverse each of these woes. But the theoretical benefits should be balanced against the theoretical risks.

The most serious long-term complications of testosterone therapy include an increased risk of benign prostate disease (BPH). Although some doctors worry that testosterone treatments might increase the risk of prostate cancer, the evidence for this is small.  Indeed, there is evidence that men with low testosterone levels (who therefore might benefit from testosterone treatment) have a higher risk of developing prostate cancer.
Do the potential gains of testosterone treatment outweigh the possible pains? Nobody knows. To date, only small, short-term studies have been completed. More research is needed to learn how testosterone affects the heart and the rest of a man’s body and mind.

The best advice is to protect your heart and your body by taking care of known risk factors, such as cholesterol, blood pressure, diabetes, obesity, and tobacco exposure. And don’t forget that diet and exercise remain the keys to reducing the risk of heart disease.

April 2010 update

SOURCE

http://www.health.harvard.edu/fhg/updates/testosterone-and-the-heart.shtml

Testosterone Treatments Linked with Risk of Heart Problems, Deaths

By Bahar Gholipour, Staff Writer   |   November 05, 2013 04:00pm ET

Credit: Doctor’s visit via Shutterstock View full size image

Men with signs of heart problems who take injections of testosterone or use gel containing the hormone may have an increased risk of heart attack or stroke, a new study finds. The findings call for more cautious prescribing of testosterone, doctors say.

In 2011, 5.3 million prescriptions for testosterone were written in the United States. Testosterone therapy is often prescribed to men in order to counteract the age-related decline in the hormone and improve sex drive, bone density and muscle mass. But the benefits and risks of the long-term use of testosterone therapy are not well known.

In the new study, Dr. Rebecca Vigen, a researcher at the University of Texas, and her colleagues looked at 9,000 male veterans who had undergone coronary angiography between 2005 and 2011, a procedure for testing the arteries when people have symptoms such as chest pain or are at high risk for heart problems. The men, whose average age was 60, were also found to have low testosterone levels during their exam, and 1,200 of them started testosterone therapy after their tests.

The researchers followed up with the men after an average of 2.4 years after their angiography. During the study, 26 percent of men who were receiving testosterone therapy had either a heart attack or a stroke, or died from any cause, while 20 percent of men who did not receive testosterone therapy had experienced such events or died. [5 Myths About the Male Body]

In other words, the men who used testosterone therapy had a 30 percent increased risk of heart attack, stroke or dying, compared with men who didn’t use the hormone, and the results held after being adjusted for several other factors that could have affected the outcomes, according to the study, published today (Nov. 5) in the Journal of the American Medical Association (JAMA).

The results “make us take a pause, and make sure that everyone taking testosterone is taking it for the right reasons and is experiencing benefits,” said Dr. Anne Cappola, an associate professor of medicine at the University of Pennsylvania who wasn’t involved in the study.

Doctors and patients should be wary of the aggressive marketing used by testosterone manufacturers, Cappola said.

“There’s a lot of marketing out there of testosterone and low-T syndrome, and a lot of men who want to feel better,” she said. “So that marketing appeals to them, but they are not hearing any of the risks side, which is often harder to quantify.”

In the United States, rates of testosterone prescription tripled between 2000 and 2011, reaching sales of $1.6 billion in 2011, according to a previous study.

The researchers said the new study was prompted by a recent clinical trial of testosterone therapy in men who were at high risk for heart disease. That study was stopped early, due to higher rates of heart problems in the group receiving the hormone.

All of the men in the new study generally had higher rates of medical conditions — including coronary artery disease, diabetes and previous heart attacks — than men in the general population.

Cappola said the study participants represented a “real-world” population of men who have more health problems than the men enrolled in most randomized clinical trials do.

The researchers noted that they couldn’t verify whether the men in the study had been prescribed testosterone according to doctors’ guidelines, which require doctors to draw blood in the morning on two different days and look for medical problems that could be related to testosterone deficiency. Cappola said there’s evidence that sometimes patients are prescribed testosterone without having their hormone levels properly checked.

It is still unclear whether the results extend to other populations of men — for example, men of the same age group who are taking testosterone for low-T syndrome or for anti-aging purposes, or younger men taking it for physical enhancement.

“Although physicians should continue to discuss the benefits of testosterone therapy with patients, it is also important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy might be harmful,” the researchers said.

Email Bahar Gholipour or follow her @alterwired. Follow LiveScience @livescience, Facebook & Google+. Original article on LiveScience.

Editor’s Recommendations

• 8 Tips for Healthy Aging
• 5 Myths About the Male Body
• Beyond Vegetables and Exercise: 5 Surprising Ways to Be Heart Healthy

SOURCE

http://www.livescience.com/40964-testosterone-therapy-heart-disease.html

Popular Testosterone Therapy May Raise Risk Of Heart Attack

by RICHARD KNOX

January 30, 201410:14 AM

Some men take testosterone hoping to boost energy and libido, or to build strength. But at what risk?

iStockphoto

There’s new evidence that widely prescribed testosterone drugs — touted for men with flagging libidos and general listlessness — might increase the risk of heart attacks.

A study of more than 55,000 men found a doubling of heart attack risk among testosterone users older than 65, compared with men who didn’t take the drug.

The research was inspired by a smaller study published in 2010 that hinted at an elevated risk among frail, older men who were on testosterone replacement therapy. The earlier study was halted ahead of schedule because of a higher rate of heart attacks, strokes and other cardiovascular problems.

Shots – Health News

Big Questions About Testosterone Treatment For Men

What’s new, says William Finkle, lead author of a study published Wednesday by PLOS ONE, is that in men younger than 65 with known heart disease, “we also found a twofold increase in risk of nonfatal heart attack shortly after initiation of testosterone therapy.”

Nonusers had a risk of heart attack of 5 per 1,000 men followed for 1 year, while testosterone users older than 65, and those under 65 with known heart disease, had an absolute risk of 10 per 1,000 patient years. These numbers were adjusted to account for other health issues, including high blood pressure, diabetes and smoking.

Shots – Health News

Testosterone Supplements Build Strength, But May Harm Older Hearts

As men age, their production of testosterone falls. For some, testosterone drops so low that it becomes a medical problem. But millions of U.S. men use testosterone drugs as lifestyle drugs, resorting to replacements to reverse a natural decline. In a sign of the drugs’ popularity, sales of AbbVie’s Androgel, the leading testosterone replacement, surpassed Viagra’s in 2012.

In one frequently aired TV ad, a youthful-looking 50-something man owns up to having “low T,” which his doctor discovered after he complained of sagging energy and irritability. After taking Androgel, he’s back in the swing of things, the ad suggests, riding around in a convertible with a younger-looking woman.

Shots – Health News

One Price Of Fatherhood: Low Testosterone

With such inducements (and common symptoms), some specialists worry that many men are being prescribed testosterone drugs even if they have normal levels of the male sex hormone. The drugs cost around $300 to $400 a month, but companies are offering to cover patients’ insurance copayments or are giving away the first month’s supply.

In addition to the new study and the one in 2010, a Veterans Affairs study last November found a higher rate of heart attacks, strokes and deaths among 1,223 men taking testosterone therapy, compared with 7,486 who didn’t get the hormone treatment.

Finkle, who’s with a California firm called Consolidated Research, tells Shots that “the risk of heart attack should be added to the discussion between patients and physicians” before anyone starts testosterone treatment.

He also says the Food and Drug Administration should require a warning on the labels of testosterone drugs such as Androgel and Axiron. “We have a 2010 study that was canceled because of unexpected cardiovascular risk,” he tells Shots. “I think that was sufficient to justify a warning. Why withhold that from the patient?”

Dr. Sidney Wolfe, of the Health Research Group, tells Shots that his consumer advocacy organization plans to petition the FDA, asking for a strong warning on the instructions for testosterone drugs. The group also intends to ask the FDA to hold off on a long-acting, injectable form of testosterone called Aveed. The agency is expected to make a decision on the drug in February.

But at least one advocate of testosterone therapy says the evidence of risks is overblown and poorly founded. “It feels almost like it’s open season on testosterone,” Boston urologist Abraham Morgentaler tells Shots. “None of the studies is very impressive.”

Morgentaler, author of Testosterone for Life, published by Harvard Health Books, says authors of the latest study “have made the classic mistake of confusing treatment for a condition with the condition. There’s a rich literature spanning more than 20 years that shows low testosterone itself is a risk factor for cardiovascular events.”

He also criticizes the new study for not following patients long enough, and notes that the rate of heart attacks among testosterone users was low.

It’s “high time” for a study of testosterone therapy involving a large number of men who are followed for years, Morgentaler says, similar to the Women’s Health Initiative study on postmenopausal estrogen supplements.

“There is potential for testosterone to be important for general health and longevity,” Morgentaler says. “There’s strong evidence it increases muscle strength and decreases fat — things we would associate with improved health.”

But large, lengthy studies cost hundreds of millions of dollars. And in the case of estrogen replacement, that sort of research ultimately discredited the long-held belief that taking hormone supplements lowers the risk of heart attacks.

SOURCE

http://www.npr.org/blogs/health/2014/01/29/268427675/popular-testosterone-therapy-may-raise-risk-of-heart-attack

Cardiovascular Issues in Hypogonadism and Testosterone Therapy

Ridwan Shabsigh, MD,* Mark Katz, MD, Grace Yan, BA, and Nawras Makhsida, MD

A systematic literature search was conducted to investigate the cardiovascular issues related to hypogonadism and testosterone therapy. Vascular cells contain sex steroid hormone receptors. Testosterone can exert effects on the vascular wall, either by itself or through aromatization as estrogen. Hypogonadism is associated with central obesity; insulin resistance; low levels of high-density lipoprotein (HDL); high cholesterol levels; and high levels of low-density lipoprotein (LDL), triglycerides, fibrinogen, and plasminogen activator–1.

Some observational studies show a correlation between low testosterone and cardiovascular disease (CVD), and others show no correlation.

Interventional studies do not reveal a direct long-term relation between testosterone therapy and CVD. Short-term data suggest cardiovascular benefits of testosterone. Testosterone therapy has beneficial and deleterious effects on cardiovascular risk factors. It improves insulin sensitivity, central obesity, and lowers total cholesterol and LDL. In some studies, testosterone therapy has an HDL-lowering effect, and in other studies this effect is insignificant. This should not be assumed to be atherogenic because it might be related to reverse cholesterol transport and effects on the HDL3 subfraction.

The cardiovascular effects of testosterone therapy may be neutral to beneficial. There is no contraindication for testosterone therapy in men with CVD and diagnosed hypogonadism with or without erectile dysfunction. Caution should be exercised regarding occasional increases in hematocrit levels, especially in patients with congestive heart failure. Conversely, evidence does not support testosterone therapy in aging men for the purpose of cardiovascular benefit, despite claims to this effect. Further research on the cardiovascular benefits and risks of testosterone is strongly recommended. © 2005 Elsevier Inc. All rights reserved.

SOURCE

Am J Cardiol 20052005;96[suppl]:67M–72M

Testosterone treatment in hypogonadal men may reduce cardiovascular disease risk

Published on October 24, 2013 at 1:06 AM · No Comments

Research from Boston University School of Medicine (BUSM) suggests that testosteronetreatment in hypogonadal (testosterone deficient) men restores normal lipid profiles and may reduce the risk of cardiovascular disease. These finding currently appear online in the International Journal of Clinical Practice.

Metabolic syndrome (MetS) is associated with increased risk for cardiovascular disease and diabetes mellitus. There is a strong association between MetS and testosterone deficiency.

Hypogonadal men are more likely to suffer from metabolic syndrome characterized by dyslipidemia, insulin resistance, diabetes and hypertension. Additionally, obese and overweight men also may exhibit testosterone deficiency.

In this observational study, BUSM researchers investigated the effects of testosterone treatment in 255 hypogonadal men between the ages of 33-69 and followed them for a period of five years. They found that men treated with testosterone therapy experienced a gradual reduction of their total cholesterol, low density lipoproteincholesterol (LDL/bad cholesterol), triglycerides and increased high density lipoprotein (HDL/(good cholesterol). “In addition to improving their cholesterol levels, we found that the testosterone treatment resulted in marked reductions in systolic and diastolic blood pressure as well, suggesting amelioration of hypertension,” explained lead author Abdulmaged M. Traish, MBA, PhD, professor of biochemistry and urology as well as Research Director of the Institute of Sexual Medicine at BUSM.

Traish found this treatment also reduced fasting blood glucose and hemoglobin A1c, a surrogate marker of hyperglycemia, suggesting that testosterone treatment may improve insulin sensitivity and hyperglycemic control. It also reduced the levels of inflammatory biomarkers such as C-reactive protein (CRP) and markers of liver dysfunction such as alanine aminotransferase and aspartate aminotransferase, suggesting reduction in the inflammation responses.

“These data are congruent with our previous work in which we reported that long-term testosterone resulted in a gradual decline in weight and waist circumference and strongly suggests that testosterone therapy in hypogonadal men may prove useful in reducing the risk of cardiometabolic diseases,” he added.

Source: Boston University Medical Center

SOURCE 

http://www.news-medical.net/news/20131024/Testosterone-treatment-in-hypogonadal-men-may-reduce-cardiovascular-disease-risk.aspx

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TP, Valkonen VP, Salonen R, Salonen JT. Testosterone and sex

hormone-binding globulin predict the metabolic syndrome and diabetes

in middle-aged men. Diabetes Care 2004;27:1036 –1041.

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Med 1992;117:807– 811.

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Testosterone, sex hormone-binding globulin, and the development of

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Massachusetts male aging study. Diabetes Care 2000;23:490–494.

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72M The American Journal of Cardiology (www.AJConline.org) Vol 96 (12B) December 26, 2005

 

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Clinical Effects and Cardiac Complications of Recreational Drug Use: Blood pressure changes, Myocardial ischemia and infarction, Aortic dissection, Valvular damage, and Endocarditis, Cardiomyopathy, Pulmonary edema and Pulmonary hypertension, Arrhythmias, Pneumothorax and Pneumopericardium

January 30, 2014 by 2012pharmaceutical

Clinical Effects and Cardiac Complications of Recreational Drug Use: Blood pressure changes, Myocardial ischemia and infarction, Aortic dissection, Valvular damage, and Endocarditis, Cardiomyopathy, Pulmonary edema and Pulmonary hypertension, Arrhythmias, Pneumothorax and Pneumopericardium

Reporter: Aviva Lev-Ari, PhD, RN

West J Med. 2000 December; 173(6): 412–415. PMCID: PMC1071198

The cardiac complications of recreational drug use

Azad Ghuran¹ and Jim Nolan²

Author information ► Copyright and License information ►

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INTRODUCTION

The use of recreational drugs has reached epidemic proportions in many countries and threatens to overwhelm economic, social, and health care systems. It is estimated that almost 1 in 4 people in developed countries have used recreational drugs at some time during their life. It is therefore inevitable that many doctors will have to manage and treat the ill effects associated with the abuse of these drugs.

In addition to their effects on the central nervous system, many of these agents induce profound changes in the heart and circulation that are responsible for a significant proportion of drug-related morbidity. This article reviews the cardiovascular complications associated with some of the commonly used recreational drugs.

Summary points

• The abuse of recreational drugs is common and it is inevitable that doctors will have to manage and treat their associated ill effects
• Recreational drugs are complex and can induce profound changes in cardiovascular function, both acute and chronic
• Recreational drugs are often taken together, which can result in complex synergistic interactions with potentially detrimental effects
• A high index of suspicion with early intervention and management is often the key to successful treatment

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METHODS

Data were obtained by electronically searching MEDLINE, Embase, Poisindex (Micromedex Healthcare Series 2000), and standard textbooks of pharmacology and toxicology. Specific drugs or their chemical names were used as the main search term.

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DRUGS AND SUBSTANCES

Cocaine, amphetamine, and ecstasy

Pharmacology

Cocaine, amphetamine, and ecstasy all share similar adverse effects on the cardiovascular system, related predominantly to sympathetic nervous system activation. Cocaine and its free-base form crack act by inhibiting the re-uptake of norepinephrine and dopamine at sympathetic nerve terminals. Circulating catecholamine concentrations can be elevated as much as 5-fold in cocaine users.¹ At high doses, cocaine can impair myocyte electrical conduction and contractility.¹

Amphetamine and its derivative ecstasy produce indirect sympathetic activation by releasing norepinephrine, dopamine, and serotonin from central and autonomic nervous system terminals. ​terminals.

Table 1

Suggested mechanisms by which cocaine, amphetamine, and ecstasy can cause hypotension
Paradoxical suppression of the central sympathetic nervous system Relative catecholamine depletion Acute myocardial depression due to ischemia, direct toxic effect of the drug Mechanical complications, such as acute aortic rupture, tension pneumothorax, pneumopericardium

Clinical effects

Sympathetic activation can lead to varying degrees of tachycardia, vasoconstriction, unpredictable blood pressure effects, and arrhythmias, depending on the dose taken and the presence or absence of coexisting cardiovascular disease.

Blood pressure changes

The high levels of circulating catecholamines and sympathetic activation commonly cause hypertension. However, hypotension can also occur (see box).²

Myocardial ischemia and infarction

Cocaine and amphetamine can cause myocardial ischemia and infarction in patients with or without coronary artery disease. The mechanism is uncertain, but may be related to the elevated catecholamine concentration, which increases myocardial oxygen demand, coronary artery spasm, platelet aggregation, and thrombus formation.^2,3,4 Cocaine can produce a procoagulant effect by decreasing concentrations of protein C and antithrombin 3 and potentiating thromboxane production.²

Long-term use of cocaine and amphetamine can cause repetitive episodes of coronary spasm and paroxysms of hypertension, which may result in endothelial damage, coronary artery dissection, and acceleration of atherosclerosis.

Aortic dissection, valvular damage, and endocarditis

Paroxysmal increases in blood pressure can lead to aortic dissection or valvular damage that increases the risk of endocarditis affecting mainly left-sided cardiac structures.¹ Endocarditis is often associated with unusual organisms such as Candida, Pseudomonas, or Klebsiella and frequently has an aggressive clinical course with marked valvular destruction, abscess formation, and a need for surgical intervention.

Cardiomyopathy

Prolonged administration of cocaine or amphetamines can also lead to a dilated cardiomyopathy.² Etiologic mechanisms include repeated episodes of subendocardial ischemia and fibrosis and myocyte necrosis produced by exposure to excessive catecholamine concentrations, infectious agents, and heavy metal contaminants (manganese is present in some cocaine preparations).

Pulmonary edema and pulmonary hypertension

Noncardiogenic pulmonary edema and pulmonary hypertension can also occur with cocaine and amphetamine misuse, although the precise underlying mechanism remains unknown.

Arrhythmias

The adverse cardiovascular changes and sympathetic stimulation associated with cocaine and amphetamine ingestion predispose to myocardial electrical instability, precipitating a wide and unpredictable range of supraventricular and ventricular tachyarrhythmias. The presence of fibrotic scars, myocardial ischemia, and left ventricular hypertrophy can act as a substrate for arrhythmogenesis. Cocaine possesses class 1 antiarrhythmic properties (blocks sodium channels) and can impair cardiac conduction causing prolongation of the PR interval, QRS complex, and QT interval. Cocaine can also cause a wide range of bradyarrhythmias, including sinus arrest and atrioventricular block.

Pneumothorax and pneumopericardium

Cocaine inhalation in association with a forced Valsalva maneuver (the positive ventilatory pressure increases drug absorption and therefore enhances the drug effect) can rarely give rise to a pneumothorax or pneumopericardium.

Lysergic acid diethylamide (LSD) and psilocybin (“magic mushrooms”)

Pharmacology

Lysergic acid diethylamide (LSD) and psilocybin are commonly used hallucinogenic agents that are structurally related and have similar physiologic, pharmacologic, and clinical effects. LSD is about 100 times more potent than psilocybin. Their mechanisms of action are complex with various agonist, partial agonist, and antagonist effects at serotonergic, dopaminergic, and adrenergic receptors.²

Clinical effects

The adrenergic effects of these drugs are usually mild and can give rise to general sympathetic arousal leading to dilated pupils, tachycardia, hypertension, and hyperreflexia. Although cardiovascular complications are rarely serious, supraventricular tachyarrhythmias and myocardial infarction have been reported.⁵ Changes in serotonin-induced platelet aggregation and sympathetically induced arterial vasospasm may have been contributory factors leading to the onset of myocardial infarction.⁵

Narcotic analgesics

Pharmacology

Morphine and its semisynthetic analogue heroin are the most commonly used recreational narcotic drugs. Narcotic agents act centrally on the vasomotor center to increase parasympathetic and reduce sympathetic activity.

Clinical effects

These autonomic changes, combined with histamine release from mast cell degranulation, can result in bradycardia and hypotension. Cardiac arrhythmias—including premature atrial and ventricular ectopic activity, atrial fibrillation, idioventricular rhythm, and ventricular tachyarrhythmias—have all been reported.² Bacterial endocarditis, affecting mainly right-sided cardiac structures, is a well-known complication of intravenous narcotic drug abuse, and it is sometimes associated with pulmonary abscesses. Heroin overdose can cause noncardiogenic pulmonary edema, the onset of which can be delayed for up to 24 hours after admission.⁶ A disruption in alveolar-capillary membrane integrity has been suggested as a mechanism.

Volatile substance abuse

The abuse of volatile substances is an increasing problem among young male adolescents. The products used are legal, cheap, and easily available. Following inhalation, feelings of euphoria, excitement, and invulnerability can occur rapidly, but are short-lived.

Clinical effects

Cardiac arrhythmias are presumed to be the main cause of death from volatile substance abuse. Volatile substances may induce supraventricular or ventricular tachyarrhythmias by sympathetic activation or by myocardial sensitization to circulating catecholamines.⁷ Some abusers spray the substances directly into the mouth, which can result in intense vagal stimulation and a reflex bradycardia. Profound bradycardia can evolve into asystole or secondary ventricular tachyarrhythmias. Some volatile compounds can reduce sinoatrial node automaticity, prolong the PR interval, and induce atrioventricular block.² Myocardial ischemia and infarction have been reported and are believed to be caused by a combination of coronary vasospasm, hypoxia caused by the formation of carboxyhemoglobin or methemoglobinemia, or excessive sympathetic stimulation.²Long-term misuse can induce a poorly characterized cardiomyopathy.⁸

Cannabis

Pharmacology

Cannabis has a biphasic effect on the autonomic nervous system, depending on the dose absorbed.³ Low or moderate doses can increase sympathetic and reduce parasympathetic activity, producing a tachycardia and an increase in cardiac output. In contrast, higher doses inhibit sympathetic and increase parasympathetic activity, resulting in bradycardia and hypotension. Reversible ECG abnormalities affecting the P and T waves and the ST segment have been reported.⁹It is not clear whether these changes occurred as a direct result of cannabis, independent of its effect on the heart rate.

Clinical effects

Although supraventricular and ventricular ectopic activity can occur, life-threatening tachy- or bradyarrhythmias have not been reported. In patients with ischemic heart disease, cannabis increases the frequency of anginal symptoms at low levels of exercise. This occurs as a result of a drug-induced increase in heart rate and myocardial contractility that increases myocardial oxygen demand.²

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CONCLUSION

The abuse of illegal drugs is endemic in society and has the potential to cause major acute changes in cardiovascular function and irreversible damage to the heart. These drugs are frequently taken together as “cocktails,” often in conjunction with alcohol. These combinations can have complex synergistic interactions, with potentially detrimental effects.

Many patients who present with complications will be unable or unwilling to provide a history of illegal drug use. Recreational drug use should always be suspected and looked for in patients presenting with unexplained or unusual cardiovascular disturbances associated with mood disturbances or central nervous system dysfunction. As drug misuse continues to permeate every level of society, it is inevitable that physicians will have to manage the devastating complications of these compounds. An awareness of the life-threatening cardiovascular effects, along with early diagnosis and intervention, is often the key to successful treatment.

​

Figure 1

Recreational drug use has become more widespread

Figure 2

Young people in nightclubs often take a cocktail of drugs and alcohol

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Notes

Competing interests: None declared

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References

1. Mouhaffet A, Madu E, Satmary W, Fraker T. Cardiovascular complications of cocaine. Chest1995;107: 1426-1434. [PubMed]

2. Ghuran A, Nolan J. Recreational drug misuse: issues for the cardiologist. Heart 2000;83: 627-633.[PMC free article] [PubMed]

3. Bashour T. Acute myocardial infarction resulting from amphetamine abuse: spasm thrombus interplay. Am Heart J 1994;128: 1237-1238. [PubMed]

4. Heesch CM, Wilhelm CR, Ristich J, Adnane J, Bontempo FA, Wagner WR. Cocaine activates platelets and increases the formation of circulating platelet containing microaggregates in humans.Heart 2000;83: 688-695. [PMC free article] [PubMed]

5. Borowiak KS, Ciechanowski K, Waloszczyk P. Psilocybin mushroom (Psilocybe semlanceata) intoxication with myocardial infarction. Clin Toxicol 1998;36: 47-49. [PubMed]

6. Osterwalder JJ. Patients intoxicated with heroin or heroin mixtures: how long should they be monitored? Eur J Emerg Med 1995;2: 97-101. [PubMed]

7. Flanagan RJ, Ives RJ. Volatile substance abuse. Bull Narc 1994;46: 49-78. [PubMed]

8. Wiseman MN, Banim S. “Glue sniffer’s” heart? BMJ 1987;294: 739. [PMC free article] [PubMed]

9. Kochaar M, Hosko MJ. Electrocardiographic effects of marijuana. JAMA 1973;225: 25-27.[PubMed]

SOURCE

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1071198/

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TEVA’s New Formulation of COPAXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently

January 29, 2014 by 2012pharmaceutical

TEVA’s New Formulation of COPAXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently

 Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 2/3/2018

Pfizer’s manufacturing fix clears path for Momenta’s Copaxone generic

https://www.biopharmadive.com/news/pfizers-manufacturing-fix-clears-path-for-momentas-copaxone-generic/515942/

 

UPDATED on 2/1/2017

Teva’s $1bn Copaxone Blow

Feb. 1, 2017 11:03 AM ET

 

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About: Teva Pharmaceutical Industries Limited (TEVA), Includes: GSK, HKMPF, HKMPY, MNTA, MYL, NVS, RDY, VEGPF

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Teva’s (NYSE:TEVA) efforts to extend the life cycle of its multiple sclerosis therapy Copaxone have finally run out of steam. Yesterday’s US district court ruling means that a generic version of the 40mg formulation could be on the market as soon as February, several months earlier than expected.

The worst-case scenario for Teva now looks likely; it previously said Copaxone sales could fall by $1-1.2bn if two generic 40mg competitors emerged next month, and there are already several waiting in the wings. Teva had better news in the shape of approval of its generic version of GlaxoSmithKline’s (NYSE:GSK) Advair, but this was not enough to stop its shares opening down 6% on the New York stock exchange this morning.

Copaxone copycats

Among the generic Copaxone pack are Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), whose version of the 40mg dose is under FDA review. The companies launched a 20mg version, called Glatopa, in 2015, and their 40mg product is the only one so far to show bioequivalence to Copaxone’s active ingredient, Leerink analysts said.

Meanwhile, Mylan (NASDAQ:MYL) said it was one of the first companies to challenge Teva’s patents with its ANDA; if its claim holds up it could get 180 days of market exclusivity on approval.

The Leerink analysts forecast a three-horse race between Momenta/Novartis, “another generic competitor and a Teva-authorized generic”. Others with a 40mg product include Dr. Reddy’s Laboratories (NYSE:RDY) and Amneal Pharmaceuticals.

Teva’s top five products in 2022
Estimated sales ($m)
Product	Indication	Status	2016	2022
SD-809	Huntington’s disease	Filed	–	1,019
Copaxone	Multiple sclerosis	Marketed	3,958	1,006
TEV-48125	Migraine	Phase III	–	1,003
DuoResp Spiromax	Asthma/COPD	Marketed	98	494
QVAR	Asthma/COPD	Marketed	470	478
Source: EvaluatePharma.

SOURCE

http://seekingalpha.com/article/4041484-tevas-1bn-copaxone-blow

Press Release

JERUSALEM–(BUSINESS WIRE)–Jan. 28, 2014– Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE®. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily COPAXONE® 20 mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996.

“The availability of three-times-a-week COPAXONE® 40 mg/mL is a significant advancement for patients as they now have the option of effective and safe treatment with COPAXONE®, while reducing the number of injections by 60 percent,” said Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI. “Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of COPAXONE®.”

The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1400 patients, which showed that a 40 mg/mL dose of COPAXONE® administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.

“For more than 20 years, Teva has pursued its multiple sclerosis research with the goal of providing effective, safe and tolerable therapies for MS patients,” said Larry Downey, President, North America Specialty Medicines. “We have progressively invested in the innovation of COPAXONE® in an effort to understand the needs and to ease the burden of patients who live with relapsing forms of MS every day. Today we are proud to continue to deliver on that investment by offering the freedom to dose three-times-a-week with COPAXONE® 40 mg/mL.”

Three-times-a-week COPAXONE® 40mg/mL is available for shipping to distribution outlets immediately, and will be available to patients within days. Teva’s Shared Solutions® patient support center has been scaled to support current patients as they transition to the new, three-times-a-week 40mg/mL formulation. Patients may call their doctors or Teva’s Shared Solutions® (1-800-887-8100) and make a request. In addition, Shared Solutions® provides 24/7 nurse support, financial and benefits investigation as well as identification of pharmacy distribution options to enable financial and physical access to COPAXONE®. Shared Solutions also provides free injection training as well as ongoing compliance and adherence support services.

About COPAXONE®

COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. COPAXONE® is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

Important Safety Information about COPAXONE®

Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: The following presentation contains forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative medicines, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions and license products, our ability to reduce operating expenses to the extent and during the timeframe intended by our cost restructuring program, uncertainties relating to the replacement of and transition to a new President & Chief Executive Officer, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our settlement agreements with brand companies and liabilities arising from class action litigation and other third-party claims relating to such agreements, potential liability for sales of generic medicines prior to a final resolution of outstanding patent litigation, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices ,particularly for our specialty medicines (and our ongoing FCPA investigations and related matters), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based medicines, adverse effects of political or economic instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, the termination or expiration of governmental programs or tax benefits, environmental risks, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.
IR Contacts:
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New Formulation of COPAXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently – FiercePharma http://www.fiercepharma.com/press-releases/new-formulation-copaxone-offers-patients-and-their-physicians-ability-dose#ixzz2rpdTjqo9

UPDATED: Corks are a-popping at Teva with FDA nod for its new Copaxone formula

January 28, 2014 | By Tracy Staton

UPDATED: Corks are a-popping at Teva with FDA nod for its new Copaxone formula – FiercePharma http://www.fiercepharma.com/story/corks-are-popping-teva-fda-nod-its-new-copaxone-formula/2014-01-28#ixzz2rpf9XuTM

Teva Pharmaceutical Industries hit the finish line in its long race to develop a longer-acting formulation of its multiple sclerosis treatment Copaxone. Tuesday evening, Teva ($TEVA) said the FDA had approved the three-times-weekly formula, and not a moment too soon. The Israel-based drugmaker now has till mid-May to convert as many patients as possible to the latest and greatest version, before the original drug’s patent expires.

 

Teva executives predict that 45% of current Copaxone patients will convert to the long-acting formulation. It needs as many conversions as it can get; the original is Teva’s biggest seller, with about 20% of its revenue and 50% of its profits. In 2012, the drug brought in $3 billion in the U.S. alone.

 

There’s no word yet on pricing for the longer-acting dose, and Teva’s full-year 2013 figures aren’t yet out, so there’s no way to guesstimate how much a 45% conversion would be worth, dollar-wise. We’ll leave that number crunching to the analysts; their consensus estimates are for $4.2 billion in global Copaxone sales for 2013.

 

Suffice it to say that Teva should be thrilled if its conversions keep ahead of generic erosion once copycat rivals hit the market. With patent protection till 2030 on this model, it could pay off for many years to come. But that’s not a given; new formula or old, Copaxone does face competition from other brands, including the Novartis ($NVS) pill Gilenya, Sanofi’s ($SNY) Aubagio, and Biogen Idec’s ($BIIB) new-and-hot Tecfidera.

 

The new formula is shipping immediately and will be available to patients “within days,” the company said in a statement. Teva has staffed up at its patient support center–Shared Solutions–to help current patients move to the thrice-weekly formulation. That means help navigating insurance coverage, finding the right pharmacy, and for some, financial assistance. Patients can even call the hotline directly to ask to switch. Of course they can also call their doctors, and DTC ads will no doubt soon urge them to do so. And Teva reps have been gearing up for some time to spread the word to physicians.

 

The company thought it would have 18 more months to persuade patients to make the Copaxone switch, but a U.S. appeals court last year invalidated a patent that expired next November. Now, the fuse runs out in May. Teva hasn’t given up on the original formula, though. Last week, the company asked the U.S. Supreme Court to take up its patent case. And it’s still arguing for stepped-up FDA scrutiny for any would-be Copaxone copycats. Meanwhile, Teva continues to cut costs and lay off workers in a worldwide restructuring designed to save $2 billion.

 

Related Articles:

Teva appeals to Supreme Court for help thwarting Copaxone rivals

Teva braces for a $550M hit from Copaxone generics

CHMP recommendation adds to Teva’s financial turmoil

Teva plots 5,000 more job cuts in $2B savings drive
New Formulation of COPAXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently – FiercePharma http://www.fiercepharma.com/press-releases/new-formulation-copaxone-offers-patients-and-their-physicians-ability-dose#ixzz2rpZ3IkD9

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Posted in Bone Disease and Musculoskeletal Disease, Immunodiagnostics, Innovations in Neurophysiology & Neuropsychology, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Regulated Clinical Trials: Design, Methods, Components and IRB related issues | Leave a Comment »

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