FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF

The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest…

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Autopsy Studies Find Large And Dramatic Drop In Early Atherosclerosis Over 60 Years

Service members who died over the past decade were far less likely to have atherosclerosis than service members who died in Korea or Vietnam, according to a new study published in JAMA. Although it is impossible to fully understand the causes and implications of the finding, the results provide powerful new evidence pointing toward a very…

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FDA Approves Lomitapide For Homozygous Familial Hypercholesterolemia

Aegerion Pharmaceuticals said today that the FDA had approved lomitapide (Juxtapid) to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The approval comes with a box warning about the risk of hepatotoxicity and a Risk Evaluation and Mitigation Strategy (REMS) Program which will require certification of health care providers and pharmacies before the drug…

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2012 In Review: A Bad Year For Conventional Wisdom

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…

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2012 In Review: Social Media In Cardiology

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For a whole variety of reasons most cardiologists are not really comfortable diving into social media. For some reason they’re more comfortable remaining poolside, reading Braunwald or the latest mini JACC or Circulation than writing a blog or interacting with each other or their patients on Facebook or Twitter. Most cardiologists who do get their feet wet send out a few…

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New York Post Disavows Portions Of Article About Jeffrey Moses

The New York Post has substantially disavowed significant portions of an October 22 news story about Jeffrey Moses. The story contained allegations that the well-known interventional cardiologist had tested positive for cocaine but was allowed to continue performing procedures at New York-Presbyterian Hospital. Now, the Post says, allegations of cocaine use were “subsequently proven to be conclusively false…

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HPS2-THRIVE: No Benefit, Signal Of Harm For Niacin Therapy

The largest-ever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release…

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Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves

Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that…

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Promising One Year Results For Renal Denervation In Resistant Hypertension Spark Hype

Denervation of the renal sympathetic nerve may become an important new tool in the fight against resistant hypertension.  Previously, the main results of the Symplicity HTN-2 trial demonstrated that in selected patients renal denervation resulted in a large and highly significant reduction in systolic blood pressure (BP) at six months. Now, longer followup from the trial, published…

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Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement…

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JACC Issues Notice of Concern Over Three Poldermans Papers

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The editors of the Journal of the American College of Cardiology have issued a “Notice of Concern” over three JACC articles in which Don Poldermans, the disgraced Dutch researcher, served as the first or the last author. The editors relied on the report of the investigation committee at Erasmus Medical Center published in October. In each case the…

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New Guidelines Define State-of-the-Art STEMI Care

New guidelines published online today in Circulation and the Journal of the American College of Cardiology provide an efficient overview of the best treatments for STEMI patients. (Click here to download the PDFs of the full version (64 pages) or the executive summary  (27 pages) of the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction.) “We’re looking to a future where more…

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American Heart Association Lists Top 10 Research Advances

The AHA has published its annual list of the top 10 advances in heart disease and stroke research. It’s probably worth remarking that not a single item on the list is related to drug therapy. I haven’t gone back and checked past lists, but I would bet this hasn’t happened before. Here’s the list: Extended…

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CHMP Recommends Against Approval For Mipomersen In Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro, Isis and Genzyme) not be approved for use in Europe. The novel antisense oligonucleotide works by inhibiting the synthesis of apo-B and is under development in the United States and Europe for the treatment of familial hypercholesterolemia….

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Hypertension And Smoking Top List Of Global Risk Factors

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Worldwide, hypertension and tobacco smoking are the single largest causes of death and disability, according to findings from the Global Burden of Disease Study 2010 (GBD 2010), the largest ever assessment and analysis of global health and disease. In an unprecedented move, the Lancet devoted an entire issue to the study, including seven separate articles and eight comments….

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FDA Safety Review Finds Small, Nonsignificant Increased Risk With Chantix (Varenicline)

The FDA today updated its safety review of the smoking cessation drug varenicline (Chantix, Pfizer). A large meta-analysis, which the FDA had required Pfizer to perform, found a higher rate of major adverse cardiovascular events (MACE) in patients taking varenicline than in patients taking placebo. However, the increase in risk was very small and did not achieve statistical…

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State Of The Heart: AHA Publishes Year-End Statistical Update

Although deaths from cardiovascular disease have been declining for many years, continued progress is threatened by disturbing trends in US lifestyles. That’s the clear message from the American Heart Association’s year-end report, “Heart Disease and Stroke Statistical Update 2013,” published in Circulation. “Americans need to move a lot more, eat healthier and less, and manage risk…

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Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients

Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…

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No Surprise: Smoking and Sudden Cardiac Death Closely Tied

Although cigarette smoking has long been linked to cardiovascular (CV) disease and sudden cardiac death (SCD),  the precise contribution of smoking, and the effect of smoking discontinuation, on SCD has not been clear. Now a new report from the Nurses’ Health Study published in Circulation: Arrhythmia & Electrophysiology provides new clarity about the relationship between smoking…

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Prolonged Anticoagulation With Apixaban Found Beneficial In Venous Thromboembolism

A new study suggests that extending anticoagulant therapy for an additional year may be beneficial after patients with venous thromboembolism complete their initial course of therapy. The results of AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment) were presented at the annual meeting of the American…

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Should Body Weight Influence Choice of Antihypertensive Therapy?

The hypertension field has been troubled by repeated observations that normal weight patients have more cardiovascular (CV) events than obese patients. Now a new analysis of a large hypertension trial confirms this finding but also suggests that it may be explained by either an adverse effect of diuretics or a protective effect of calcium-channel blockers in non-obese…

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Study Suggests Aspirin Resistance May Not Be Real

Is it resistance or pseudoresistance? According to a new study published in Circulation, aspirin resistance may be a myth, an artifact of the enteric coating of most aspirin tablets. The coating, which is designed to prevent gastrointestinal side effects caused by aspirin, may delay or conceal the effects of the drug, the study suggests, but the antiplatelet effects of…

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Scientific Statement Examines Role Of Social Media In Fighting Childhood Obesity

Social media may become an important weapon in the battle against childhood obesity, according to a new American Heart Association scientific statement published in Circulation. However, the statement acknowledges that the evidence so far from published social-media intervention studies has been “mixed” and that social media is also associated with troublesome drawbacks. The statement delivers an overview of…

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Exercise And The Limitations Of Observational Studies

Last week I wrote twice about exercise. Strictly speaking, both stories were complete lies. The first story was about a study published in the Lancet which analyzed data from more than 10,000 patients at 2 VA Medical Centers and found that patients with high fitness levels were less likely to die than patients with low fitness levels. The pattern held…

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