The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of…

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The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the…

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The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers,…

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FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers…

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In ancient Greece the philosopher Aristotle thought the golden mean was the desirable middle between two extremes, one of excess and the other of deficiency. In cardiology, apixaban may be the golden mean of anticoagulation, achieving the ideal balance of reduced strokes and deaths without causing any additional bleeding complications. The Apixaban for Reduction in Stroke and…

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In ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), researchers tested rivaroxaban (20 mg/day) against warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF). The results of the trial, which were first presented last November at the American…

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Pfizer and Bristol-Myers Squibb said that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study. The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor apixaban…

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Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation: Class I: Dabigatran is useful as an alternative to warfarin…

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A new trial presented at the American Stroke Association’s International Stroke Conference and published online in the New England Journal of Medicine demonstrates that the novel factor Xa inhibitor apixaban is better than aspirin for the prevention of stroke in AF patients who are unable to take warfarin. Stuart Connolly and investigators in the AVERROES (Apixaban…

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A focused update on the guidelines for the management of atrial fibrillation has been released by the American College of Cardiology, American Heart Association, and Heart Rhythm Society. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights: Dronedarone can…

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