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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There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist…

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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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An electrophysiologist and blogger places the recent approval of rivaroxaban in the context of the seismic changes that have taken place and that are still expected in the anticoagulant marketplace.

Rivaroxaban (Xarelto, Janssen) received FDA approval today for the prevention of deep-vein thrombosis in patients undergoing knee or hip replacement surgery. This oral anticoagulant has been approved for use at a 10-mg dose, once daily, for 35 days following hip replacement and for 12 days following knee replacement surgery. The company has also submitted an…

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The novel anticoagulant rivaroxaban is successful in preventing venous thromboembolism (VTE) in acutely ill medical patients, but a high bleeding rate means the drug probably won’t be used for this indication. Alexander Cohen, presenting the results of the MAGELLAN trial at the ACC in New Orleans, explained by way of background that 50% to 70%…

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In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for…

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With the approval of dabigatran and now the preliminary and partial results of ROCKET AF, we’ll  need to be familiar with much more than just warfarin to address the anticoagulation needs of our patients. The early word on ROCKET AF, which will be presented at AHA, is that rivaroxaban is at least as effective as warfarin…

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