Decision on Apixaban (Eliquis) Pushed Back By Three Months

Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…

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FDA Revises the Safety Labeling of Statins

The FDA today announced important new changes to the safety language on the labels of statins: Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or…

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FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients

The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk of cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months…

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Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents…

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Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients

Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting…

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YouTube, NEJM, Whitney Houston, and Alpha Male Monkeys

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Take a close look at this screenshot from YouTube (click to expand): Jim Ware, the legendary New England Journal of Medicine biostatistician: 8 views. Jerome Kassirer, Marcia Angell, and Arnold Relman, former NEJM editors: 36, 28, and 257 views. Whitney Elizabeth Houston Funeral Service: 994,920 views. (And how many more Whitney Houston videos do you think…

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FDA Advisory Panel Gives Green Light to Qnexa Diet Pill

Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of  phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this…

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Guest Post: More Lessons From the Riata ICD Lead Recall

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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. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the…

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More Rigorous Family History Improves CV Risk Assessment

Although family history has long been recognized as an important cardiovascular risk factor, usual methods to assess risk have not incorporated the family history in a rigorous manner. A new study published in Annals of Internal Medicine finds that systematically collecting family history in a primary practice setting significantly increases the identification of high risk people. Nadeem Quereshi…

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FDA Approves Medtronic’s Resolute Drug-Eluting Stent for Treatment of CAD, Including Diabetics

Resolute Integrity DES_Expanded on Balloon

The FDA has approved the Medtronic Resolute zotarolimus-eluting stent for the treatment of coronary artery disease. The Resolute DES is approved for use in a wide variety of patients, including diabetics. The new stent uses the same drug-and-polymer combination as the popular Resolute Integrity DES. The Resolute clinical trial program enrolled more than 5,000 patients worldwide, a…

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Industry Supported Editorial Assistance: The Debate Continues

Editor’s Note: Here is the latest installment of a debate over industry-sponsored editorial assistance between Tom Yates, a UK-based physician critical of the role of industry in medical publishing, and Karen Wooley, who owns a medical education company and is a representative of the the Global Alliance of Publication Professionals (GAPP). (The previous installments of the…

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Japanese Researcher With Harvard Connections Retracts 3 Articles in AHA Journals

Akio Kawakami, a well published lipid researcher at Tokyo Medical and Dental University, has retracted 3 papers from AHA journals, including one article in AHA’s flagship journal Circulation. News of the retractions was first reported on Retraction Watch. Two of Kawakami’s co-authors are well known researchers affiliated with Harvard University and the Brigham and Women’s Hospital, Peter Libby and…

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AHA Scientific Statement Spotlights Peripheral Artery Disease in Women

Although peripheral artery disease (PAD) raises the risk of heart disease and stroke, it often goes undiagnosed and untreated, especially in women, according to a scientific statement issued by the American Heart Association and published in Circulation. Here are a few highlights of the statement: Although women develop PAD later than men, the total number…

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Metaanalysis: Air Pollutants Raise Short Term Risk of MI

Air pollution significantly raises the short-term seven-day risk of myocardial infarction (MI), according to a new metaanalysis published in JAMA. Hazrije Mustafic and colleagues analyzed data from 34 studies and found a significant increase in the relative risk (RR) of MI for all the main air pollutants except ozone: carbon monoxide: RR 1.048, CI 1.026-1.070 nitrogen…

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Guest Post: What Are the Lessons of the Riata ICD Lead Recall?

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. What Are the Implications of the Riata ICD Recall? by Edward J. Schloss, MD This week the New England Journal of Medicine published an…

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A Defense of Professional Medical Writers

Updated on February 16 with a response by Tom Yates to Karen Woolley. Editor’s Note: In response to a recent guest post by Tom Yates on industry sponsored editorial assistance, the following comment was submitted  by Karen Woolley on behalf of the Global Alliance of Publication Professionals. This thoughtful statement deserves attention, but I would point out…

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Metaanalysis Raises More Questions About Routine Use of Aspirin for Primary Prevention

Although aspirin can reduce the risk of cardiovascular (CV) events, the associated increase in bleeding suggests that it should not be used routinely in  people without prior CV disease, say the authors of a new meta-analysis published in Archives of Internal Medicine. Sreenivasa Rao Kondapally Seshasai and colleagues combined data from 9 clinical studies including…

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Guest Post: Industry Sponsored Editorial Assistance

Editor’s Note: The following guest post by Tom Yates is reprinted with permission from his blog Sick Populations. Yates is a UK-based physician with an interest in epidemiology and population health. Industry Sponsored Editorial Assistance by Tom Yates The September 2011 edition of the Quarterly Journal of Medicine contained two review articles which dealt with the use…

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The Y Chromosome May Explain Why Men Have Earlier Coronary Disease

The earlier onset of coronary artery disease in men has long provoked speculation and research. Now a new study in the Lancet suggests that common variations in the Y chromosome (which is transmitted directly from father to son and does not undergo recombination) may play an important role in the increased risk seen in men. Using…

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Prominent Interventionalists Attack Appropriate Use Criteria For PCI

A group of leading interventional cardiologists has launched an attack on the growing role of appropriate use criteria (AUC) for PCI in the US. They argue that severe flaws in current guidelines render unreliable current attempts to assess the rate of appropriate procedures. In a paper published in  JACC: Cardiovascular Interventions, Steven Marso and colleagues (Paul…

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Bleeding Problems Continue To Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar

In the large TRA-2P  study of more than 26,000 patients with  MI, ischemic stroke, or documented peripheral vascular disease, the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke or urgent coronary revascularization. But vorapaxar treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to…

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Women and ICDs: More Complications and Fewer Benefits

After consulting an electrophysiologist, women are just as likely as men to receive an ICD but they suffer more complications and are less likely to benefit from the device, according to a new study from Canada published in Annals of Internal Medicine. Derek MacFadden and colleagues analyzed data from 6,021 patients treated at 18 ICD…

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CMS Releases Details Of Proposed National Coverage For TAVR

(Updated with statement from the ACC and STS) On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and…

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Study Explores Role of Periprocedural Dabigatran in AF Ablation

Updated with a comment from John Mandrola– As dabigatran becomes more widely used in atrial fibrillation (AF) patients, electrophysiologists are now trying to figure out how to handle anticoagulation in patients taking dabigatran (Pradaxa) for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues…

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Meta-Analysis Confirms Benefits Of Statins In Women

Although clinical trials have consistently found a beneficial effects for statins, some critics have questioned the strength of the evidence in women, who are often under-represented in clinical trials.  A large new meta-analysis published in the Journal of the American College of Cardiology provides the best evidence yet that the relative reductions in events observed in…

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