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Injectable inclisiran (siRNA) as 3rd anti-PCSK9 behind mAbs Repatha and Praluent   Reporter: Aviva Lev-Ari, PhD, RN Next stop, filing for approval. The Medicines Company has said it plans to submit inclisiran for FDA review by the end of 2019 and EMA review in the first quarter of 2020. If the drug’s approved it’ll be […]

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 Cholesterol Lowering Novel PCSK9 drugs: Praluent [Sanofi and Regeneron] vs Repatha [Amgen] – which drug cuts CV risks enough to make it cost-effective? Reporter: Aviva Lev-Ari, PhD, RN   UPDATED on 1/15/2019 In the patent fight over PCSK9 inhibitors, the Supreme Court refused to hear Amgen’s appeal of a 2017 court decision allowing Sanofi and Regeneron […]

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ODYSSEY Outcomes trial evaluating the effects of a PCSK9 inhibitor, alirocumab, on major cardiovascular events in patients with an acute coronary syndrome to be presented at the American College of Cardiology meeting on March 10. Reporter: Aviva Lev-Ari, PhD, RN   For PCSK9 inhibitors, the effect on major adverse cardiovascular events has always fallen short of expectations based on […]

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FDA approval on 12/1/2017 of Amgen’s evolocumb (Repatha) a PCSK9 inhibitor for the prevention of heart attacks, strokes, and coronary revascularizations in patients with established cardiovascular disease Reporter: Aviva Lev-Ari, PhD, RN   Evolocumab was first FDA approved in 2015 for patients with familial hypercholesterolemia and others who fail to achieve LDL cholesterol lowering through diet and […]

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Reversing Heart Disease: Combination of PCSK9 Inhibitors and Statins – Opinion by Steven Nissen, MD, Chairman of Cardiovascular Medicine at Cleveland Clinic Reporter: Aviva Lev-Ari, PhD, RN UPDATED on 2/25/2019 https://www.medpagetoday.com/cardiology/prevention/78202?xid=nl_mpt_SRCardiology_2019-02-25&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CardioUpdate_022519&utm_term=NL_Spec_Cardiology_Update_Active While nearly 10% of middle-age adults in China have high risk for cardiovascular disease, only 0.6% of these high-risk individuals use statins and 2.4% […]

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PCSK9 inhibitors: Reducing annual drug prices from more than $14 000 to $4536 would be necessary to meet a $100 000 per QALY threshold per JAMA Curator: Aviva Lev-Ari, PhD, RN   UPDATED on 6/21/2017 When Cholesterol Drugs Cost $14,000, an Insurance Tug-of-War – PCSK9 inhibitors https://www.wsj.com/articles/when-cholesterol-drugs-cost-14-000-an-insurance-tug-of-war-1497889667   Our team has researched PCSK9 inhibitors as a class of drugs […]

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Efficacy and Tolerability of PCSK9 Inhibitors by Patients with Muscle-related Statin Intolerance – New Cleveland Clinic study published in JAMA 4/2016 Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN   Medical Interpretation of Study Results and the Pharmacological Treatment Context of PCSK9 Inhibitors Author: Larry H. Bernstein, MD, FCAP    The Rausse-3 Clinical […]

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UPDATED on 3/16/2019 https://www.medpagetoday.com/cardiology/prevention/78202?xid=nl_mpt_SRCardiology_2019-02-25&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CardioUpdate_022519&utm_term=NL_Spec_Cardiology_Update_Active Patients with necrotizing autoimmune myopathy from statins may benefit from a PCSK9 inhibitor, a case report from Spain noted in the Annals of Internal Medicine. PCSK9: A Recent Discovery in Understanding Cholesterol Regulation @ AMGEN Cardiovascular Reporter: Aviva Lev-Ari, PhD, RN   UPDATED on 3/28/2016 ·       by Crystal Phend  Senior Associate Editor, MedPage Today Alirocumab […]

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FDA ask Regeneron and Sanofi to assess potential Neurocognitive Side Effects of Alirocumab, PCSK9 inhibitors Class Designed to Block a Protein causing Persistence of “bad” LDL Cholesterol in the Bloodstream Reporter & Curator: Aviva Lev-Ari, PhD, RN UPDATED on 3/23/2016 PCSK9 inhibitor, Praluent, shows promise in late-stage study in reducing the frequency of apheresis therapy, […]

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SNPs in apoE are found to influence statin response significantly. Less frequent variants in PCSK9 and smaller effect sizes in SNPs in HMGCR Reporter: Aviva Lev-Ari, PhD, RN Comprehensive Whole-Genome and Candidate Gene Analysis for Response to Statin Therapy in the Treating to New Targets (TNT) Cohort John F. Thompson, PhD, Craig L. Hyde, PhD, Linda S. […]

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