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FDA Approves Apixaban for Nonvalvular Atrial Fibrillation

Apixaban, a factor Xa inhibitor, will increase physicians’ options and compete against several other oral anticoagulants.

 

2013;21(2)19.

The FDA has approved apixaban for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In a double-blind, multinational trial, the annual rate of stroke or systemic embolism was lower among persons treated with apixaban than among those who received warfarin.


A total of 18,201 patients with nonvalvular atrial fibrillation were enrolled in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Of this population, 9,120 patients were randomized to 5 mg or 2.5 mg of apixaban twice daily, and 9,081 patients were randomized to an International Normalized Ratio of 2.0 to 3.0 of warfarin. Treatment continued for a median of 89 weeks. The annual rate of stroke or systemic embolism was 1.27% for patients receiving apixaban, compared with 1.60% for patients receiving warfarin. Apixaban was associated with a statistically significant 21% reduced risk of stroke or systemic embolism, compared with warfarin.

 



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