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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ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest. The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin…

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A substudy of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrates that dabigatran is as effective in AF patients for secondary stroke prevention as it is for overall stroke prevention. In their paper in the Lancet Neurology, Hans-Christoph Diener and the RE-LY study group report the results of the trial in the predefined…

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Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the  trial’s scheduled presentation at the AHA on November 15. ROCKET AF randomized more than 14,000 patients with nonvalvular AF to either rivaroxaban or warfarin. The goal of…

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It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative says the wholesale acquisition cost (WAC) of the drug is set at $6.75 per day for 2 pills. The price will apply to both the 150-mg and the 75-mg capsules.  According to knowledgeable experts, the retail…

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The FDA announced on Tuesday that it has approved Pradaxa (dabigatran, Boehringer Ingelheim) for the prevention of stroke and blood clots in patients with atrial fibrillation. The drug will be available in 75-mg and 150-mg capsules. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,”…

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of  dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw…

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An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at…

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The AVERROES (Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Strokes) trial randomized 5600 AF patients who were unable to take warfarin to receive either aspirin or apixaban, a factor Xa inhibitor. (Another trial still underway, ARISTOTLE, is a direct comparison of warfarin and apixaban in AF.) AVERROES was stopped early after the Data Monitoring Committee…

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At last year’s ESC meeting, the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial data in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation…

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