Edoxaban, a direct oral factor Xa inhibitor under development by Daiichi Sankyo, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. The results of the trial were promising, but edoxaban may have a hard time finding its footing as the fourth new oral anticoagulant to enter the market, following dabigatran (Pradaxa), Boehringer Ingelheim; rivaroxaban (Xarelto), Johnson & Johnson; and apixaban (Eliquis), Pfizer and Bristol-Myers Squibb.
In the trial, more than 21,000 patients with moderate-to-high-risk AF were randomized to one of two regimens of edoxaban or warfarin. Both high-dose and low-dose edoxaban were found to be noninferior to warfarin for the primary endpoint of stroke or systemic embolism. Here are the on-treatment annual rates of stroke or systemic embolism:
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