Apixaban superior to warfarin in trial
The FDA has approved apixaban — the long-awaited third novel oral anticoagulant (NOAC) — for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The drug follows dabigatran (Pradaxa) and rivaroxaban (Xarelto) for this indication, which has been traditionally treated with warfarin. The safety and efficacy of apixaban was demonstrated in the 18,000 patient ARISTOTLE trial, which showed that in patients with nonvalvular AF, apixaban was superior to warfarin in preventing stroke and systemic embolism, caused less bleeding, and resulted in lower mortality than warfarin. The FDA will likely allow the manufacturers of apixaban to market the drug as "superior to warfarin." Apixaban is dosed twice a day, similar to dabigatran; rivaroxaban is dosed once a day. Apixaban and rivaroxaban are factor Xa inhibitors, while dabigatran is a direct thrombin inhibitor. No head-to-head studies have been done among the three NOACs, which are expected to compete aggressively for this lucrative market that is worth billions of dollars in sales. All three lack a reversal agent, which could potentially increase the risk of serious bleeding. Apixaban is marketed as Eliquis by Bristol-Myers Squibb and Pfizer.