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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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

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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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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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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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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Statins and Exercise, Independently Beneficial, Even Better In Combination

It’s no secret that statins and exercise are good for people with cholesterol problems. Now a new study published in the Lancet offers fresh evidence that the two appear to be independently beneficial, and that adding the two together may result in greater benefits than either alone. US researchers analyzed data from 10,043 people with dyslipidemia…

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Model Finds High Cost For ECG Screening Of Athletes

A national program of ECG screening for U.S. athletes would save almost 5,000 lives over 20 years but would cost more than $50 billion dollars, according to a paper published in the Journal of the American College of Cardiology. The advisability of routine ECG screening for athletes has divided the experts: currently the ESC recommends ECG screening…

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Yet Another Look At The Transcendental Meditation Paper

Editor’s note: Below are two responses to Robert Schneider’s defense of his Transcendental Meditation paper, which Schneider wrote in response to my earlier article about the publication of his paper.  In the first part I respond to some of the general issues raised by Schneider. The second part, from Sanjay Kaul, addresses the statistical issues discussed by…

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From Barack To Rupert, A Thanksgiving Message

Sorry for this off-topic post, but I couldn’t resist sharing this email message forwarded from a friend in Washington, DC: Thanksgiving Day, The White House Dear Rupert, I thought on this day in particular it would be appropriate for me to send a brief note expressing my gratitude for all that you did for us over…

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Investigator Defends Controversial Transcendental Meditation Paper

Editor’s Note: Here is a response by Dr. Robert Schneider to my story last week about his controversial paper on Transcendental Meditation that appeared in Circulation: Cardiovascular Quality & Outcomes. I will respond to Dr. Schneider’s post later this week. Response from Dr. Robert Schneider We appreciate the interest in our article published in Circulation: Cardiovascular Outcomes…

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Comprehensive Guidelines for Stable Ischemic Heart Disease Released

New comprehensive guidelines for the diagnosis and treatment of stable ischemic heart disease have been released by the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines, along with the American College of Physicians (ACP), American Association for Thoracic Surgery (AATS), Preventive Cardiovascular Nurses Association (PCNA), Society for Cardiovascular Angiography and…

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Mysterious Disappearing Paper Finally Reappears In Another Journal

Updated– Last year, in what may have been an unprecedented action, a paper on the effects of Transcendental Mediation (TM) in African Americans was withdrawn by the editors only 12 minutes before the paper’s scheduled publication in Archives of Internal Medicine. No definitive explanation was ever provided, though the editors and authors said that the action…

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Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing…

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NIH Trial Gives Surprising Boost To Chelation Therapy

With a result that is likely to surprise and baffle much of the mainstream medical community, a large NIH-sponsored trial has turned up the first substantial evidence in support of chelation therapy for patients with coronary disease.  Known as TACT (Trial to Assess Chelation Therapy),  the highly controversial trial was presented today at the AHA by Gervasio…

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DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System

Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26….

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The Research Agrees: Smoking Is Really Bad For You

Four new studies offer powerful evidence of the dangers of smoking and the health benefits of quitting or not being exposed to secondhand smoke. Smoking in the UK– Between 1996 amd 2001 the Million Women Study started following more than one million women aged 50 to 65 years of age. In  a report published in…

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Research And Denial At St Jude Medical

Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…

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TCT: Two PFO Closure Trials Miss Primary Endpoints

Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant  benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients  to PFO closure…

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FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of…

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FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern  that the drug might be used in lower…

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