Daiichi's edoxaban non-inferior to warfarin in Phase III trial

Daiichi Sankyo Co. Ltd. (Tokyo:4568) said once-daily 30 and 60 mg oral edoxaban each met the primary endpoint of non-inferiority to warfarin in the Phase III ENGAGE AF-TIMI 48 trial to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). Low- and high-dose edoxaban were non-inferior to warfarin in the annual incidence of stroke or systemic embolism (1.61% and 1.18%, respectively, vs. 1.5%, p=0.005 and p<0.001 for non-inferiority). Low- and high-dose edoxaban also met the primary safety endpoint of reducing the annual rate of major bleeding vs. warfarin (1.61% and 2.75%, respectively, vs. 3.43%, p<0.001 for both). The double-blind, double-dummy, international trial enrolled 21,105 patients with non-valvular AF. Data were published in the New England Journal of Medicine and presented at the American Heart Association meeting in Dallas. ...