Bristol-Myers Squib and Pfizer announced results from their Phase 3 ARISTOTLE study of Eliquis (apixaban tablet) in patients with atrial fibrillation (AF) and at least one additional risk factor for stroke. This randomized, double-blind, multicenter, head-to-head study included 18,201 patients with AF from over 1,000 centers in about 40 countries. Patients were randomized to receive either Eliquis 5mg twice daily (2.5mg twice daily in selected patients) or dose-adjusted warfarin (titrated to a target INR range of 2–3). Eliquis met the primary efficacy endpoint of non-inferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism. Eliquis also met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin.

Eliquis is an investigational oral direct Factor Xa inhibitor being developed jointly by Bristol-Myers Squibb and Pfizer.  The companies expect to submit regulatory filings in atrial fibrillation in the U.S. and Europe in the third or fourth quarter of 2011.

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