Phase 3 Results for Eliquis for Stroke Prevention and Systemic Embolism in Atrial Fibrillation

Bristol-Myers Squibb and Pfizer announced the results from its Phase 3 ARISTOTLE trial evaluating Eliquis (apixaban) for the prevention of stroke or systemic embolism in patients with atrial fibrillation and at least one risk factor for stroke compared to warfarin. ARISTOTLE included 18,201 patients with atrial fibrillation and at least one risk factor for stroke who were randomized to either Eliquis 5mg twice daily (2.5mg twice daily in selected patients) or warfarin dosed to achieve a target INR (International Normalized Ratio) of 2.0-3.0. Results show that Eliquis significantly reduced risk of stroke or systemic embolism by 21%, major bleeding by 31% and mortality by 11%.  Eliquis demonstrated non-inferiority (P<0.001) for the primary efficacy outcome, composite of stroke or systemic embolism, compared with warfarin. The relative risk reduction was 21% with annual event rates of 1.27% for Eliquis and 1.6% for warfarin in an intention to treat analysis. The secondary objective of superiority for the first outcome was also met. The predominant effect of stroke prevention was on hemorrhagic stroke, which was lower in Eliquis by 49%, along with lower ischemic or uncertain stroke by 8% than with warfarin.

Eliquis is a new oral direct Factor Xa inhibitor. It is also being investigated in Phase 3 trials for the treatment of venous thromboembolism and prevention of VTE in hospitalized acutely ill medical patients.

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