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 preventing this rare…

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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 its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs…

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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 for 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, instead of…

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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 the…

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Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI. The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI…

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

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Akio Kawakami, a well-published lipid researcher at Tokyo Medical and Dental University, has retracted three papers from AHA journals, including one article in the AHA’s flagship journal Circulation. The two other retractions were for articles in Circulation Research and Arteriosclerosis, Thrombosis, and Vascular Biology. News of the retractions was first reported on Retraction Watch. Two of Kawakami’s co-authors are well known researchers affiliated…

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Although peripheral artery disease (PAD) raises the risk for 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 of women…

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Air pollution significantly raises the short-term, 7-day risk for MI, according to a new meta-analysis published in JAMA. Hazrije Mustafic and colleagues analyzed data from 34 studies and found a significant increase in the relative risk (RR) for MI with all the main air pollutants except ozone: carbon monoxide: RR 1.048, CI 1.026-1.070 nitrogen dioxide: 1.011,…

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