In early news from the randomized ARISTOTLE trial, the novel oral direct Factor Xa inhibitor apixaban met the primary endpoint of noninferiority to warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation (A-fib). Main findings of the study were announced by Bristol-Myers Squibb and Pfizer, the drug’s codevelopers, in a June 22, 2011, statement.

The companies included no data in their press release for the ARISTOTLE (Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation) trial but, in addition to giving the gist of the primary endpoint, reported that apixaban was found superior to warfarin for the secondary endpoints of efficacy and major bleeding. Full results will be presented at the European Society of Cardiology Congress 2011 in Paris, France, on August 28, 2011.

The phase 3 ARISTOTLE trial randomized more than 18,000 A-fib patients from over 1,000 centers in about 40 countries to either apixaban (5 mg twice daily) or dose-adjusted warfarin.

Marketed under the trade name Eliquis, apixaban has been approved for prevention of venous thromboembolic events in the European Union. The companies said that they expect to submit the drug for regulatory approval for the A-fib indication in the United States before the end of this year.

Two other contenders for improving on the performance of warfarin have recently been developed. Dabigatran (Pradaxa, Boehringer Ingelhiem, Ingelheim, Germany), a direct thrombin inhibitor, was approved by the US Food and Drug Administration in 2010 based on its showing in the RE-LY trial, while rivoraxaban (Xarelto, Bayer/Johnson and Johnson, Tarrytown, NY), a direct factor Xa inhibitor, is awaiting the agency’s approval.

Source:

ELIQUIS (apixaban) Meets Primary and Key Secondary Endpoints in Phase 3 ARISTOTLE Study [press release]. Princeton, NJ: Bristol-Myers Squibb; June 22, 2011. http://www.bms.com/news/press_releases/pages/default.aspx?RSSLink=http://www.businesswire.com/news/bms/20110622006923/en&t=634445220698225589. Accessed June 24, 2011.

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