This Week In Medicine: Stop Exercising and Eat Chocolate!

It’s been a terrific few days of medical news for lazy people and chocoholics. First, a study in PLoS One provided ammunition to the exercise-averse crowd by claiming that exercise can actually be bad for some healthy people. As an added bonus, a story about the study was carried on the front page of the…

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Fascinating Debate Over Statins For Primary Prevention

The recent guest post by David Newman has prompted several thought-provoking comments. Since most readers will likely miss the comments, I’ve moved these comments to a separate post. Statin Island May 27, 2012, 3:35 PM: Thank you. Clearly, this important commentary raises questions about the integrity of Lancet as well as the authors of the study. But…

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Guest Post: Data, Drugs, And Deception– A True Story

Editor’s Note: The following guest post by Dr. David Newman is reprinted with permission from his website and blog, Smartem.Org. Dr. Newman is an Emergency Physician and Director of Clinical Research at Mt. Sinai School of Medicine in the Department of Emergency Medicine.  He is the author of the critically-acclaimed Hippocrates’ Shadow: Secrets From the House of…

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Aspirin Found To Prevent Recurrent Venous Thromboembolism

Aspirin can help prevent the recurrence of venous thromboembolism (VTE) after discontinuation of anticoagulation therapy, according to results of the WARFASA (the Warfarin and Aspirin) study published in the New England Journal of Medicine. Following 6 to 18 months of oral anticoagulation, 403 patients with first-time unprovoked VTE were randomized to aspirin (100 mg daily) or placebo…

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FDA Advisory Committee Recommends Against ACS Indication For Rivaroxaban

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against adding an indication for acute coronary syndromes (ACS) to the label  of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI…

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Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS

Here’s my live-blogg of the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider the supplemental new drug application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. Here is a link to the FDA briefing documents. ========================= 4:48: Meeting adjourned! J&J has just issued a press release…

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Studies Probe Effect Of CPAP And Sleep Apnea On Hypertension

Two studies published in JAMA provide additional but not surprising information about the relationship between obstructive sleep apnea (OSA), hypertension, and the role of continuous positive airway pressure (CPAP). In the first study, Ferran Barbé and colleagues randomized 725 people with OSA but no daytime sleepiness to either CPAP or no active treatment. Although there were…

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Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial Conduct Persist

The FDA will offer generally positive but also highly mixed advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee  when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing documents…

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You Know Nothing, Dr. Snow: Why Medicine Can’t Be More Like Facebook

Medicine can never be like Facebook, despite what Matt Herper argues over at Forbes. Perhaps he was just trolling for hits on a day when everyone is thinking about the Facebook IPO, but Herper proposed, with apparently seriousness, that medicine needs to model itself on the tech world in order to match the kind of…

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FDA Approves Generic Clopidogrels As Plavix Loses Patent Protection

For the second time in the past six months, a cardiology mainstay drug has lost patent protection and gone generic. Today the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November the best-selling drug of all time, Lipitor…

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Large Metaanalysis Finds Statins Effective in Low Risk Patients

A very large metaanalysis provides strong evidence that the relative reduction in risk of statins is at least as great in low-risk patients as in high-risk patients. The finding, write the authors, provides evidence that expansion of guidelines to lower risk populations should be considered. In their paper in the Lancet, the  the Cholesterol Treatment Trialists’ (CTT)…

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Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS

Photo of Durata promotional truck at HRS courtesy of Dr. Wes

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS by Edward J Schloss MD The St. Jude Riata ICD lead controversy took…

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No Benefit Found For Exercise Echocardiography In Asymptomatic Patients Following CABG Or PCI

Routine exercise echocardiography in asymptomatic patients after revascularization does not lead to better outcomes, according to a new study published in Archives of Internal Medicine. Although guidelines generally discourage the practice, post-revascularization stress tests are still commonly performed. Serge Harb and colleagues performed exercise echocardiography on 2,105 patients following CABG surgery or PCI and followed…

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Xience Stents Gain European Nod For Three-Month Dual Antiplatelet Therapy

The biggest drawback to drug-eluting stents has been the requirement for prolonged dual antiplatelet (DAPT) therapy following stent implantation to prevent stent thrombosis and other potential complications. The precise length of DAPT has been the subject of considerable discussion and research. Now the Xience Prime and Xience V everolimus-eluting stents have received the CE Mark…

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Returning To Detroit, William O’Neill Heads To Henry Ford Hospital

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Interventional cardiology leader William O’Neill is leaving the University of Miami Miller School of Medicine to become the medical director of the new Center for Structural Heart Disease at Henry Ford Hospital in Detroit. The new center will focus on new minimally-invasive treatments for heart failure and heart valve disease. Prior to going to Miami in 2006,…

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Revascularization In New York State: High Questionable Rates For PCI But Not CABG

A large study looking at real world usage of elective coronary artery bypass surgery (CABG) and stenting (PCI) in New York State finds that nearly two-thirds of PCI procedures have inappropriate or uncertain indications. By contrast, 90% of CABG procedures were deemed appropriate and 1.1% inappropriate. In a paper published in the Journal of the…

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HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded

In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines….

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FDA Advisory Panel Recommends Approval For Weight Loss Drug Lorcaserin

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The result signals a remarkable turnaround for the drug, which the same panel had rejected in September 2010. The vote was 18 in favor of approval, 4 against, and 1 abstention. Committee members seemed less disturbed this time around…

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Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Shedding Light On Riata At The Heart Rhythm Society Meeting by Edward J Schloss MD This morning in Boston, HRS 2012 sessions began with…

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Atorvastatin Lifts Ranbaxy While Pfizer Abandons Its Lipitor Marketing Efforts

Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States. Pfizer told the Wall Street Journal that it…

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Persistent Concerns About Lorcaserin (Lorqess) From FDA Reviewers

The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin (Lorqess, Arena). The same panel recommended against approval of the drug in September 2010, citing weak efficacy and safety concerns. The FDA reviewers do not appear to have substantially altered…

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All Dressed Up And No Place To Go: False-Positive Activation Of The Cath Lab For Primary PCI

Primary PCI is widely recognized as the best early option for patients with  ST-segment elevation myocardial infarction (STEMI). However, efforts to deliver primary PCI to the broadest possible population inevitably result in an increased number of false-positive activations of the cardiac catheterization laboratory. Now, a new studypublished in the Archives of Internal Medicine finds that the rate of…

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In AF, Women Have A Bigger Risk Of Stroke Than Men

When compared to elderly men with atrial fibrillation, elderly women with AF have a significantly elevated risk for stroke. This increased risk occurs regardless of warfarin use, according to a new study published in JAMA. Meytal Avgil Tsadok and colleagues reviewed data from Quebec, Canada on more than 80,000 AF patients at least 65 years of age. Much of…

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Roche Terminates Development Of CETP Inhibitor Dalcetrapib

Roche announced today that it had ended development of dalcetrapib, its entry in the once-promising class of HDL-raising CETP inhibitors. A data and safety monitoring board recommended that the dal-OUTCOMES phase 3 trial be stopped due to a lack of clinically meaningful efficacy. The DSMB found no evidence of safety problems….

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Politics and Transcatheter Aortic Valve Replacement

Scott Gottlieb, MD

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears: Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people. The stampede to stake a claim in a promising, highly lucrative new territory would…

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