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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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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In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating…

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Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2, the phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the data monitoring committee based on “a clinically important increase in bleeding among patients randomized to apixaban,” according to the company press release….

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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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