Randomized, Multicenter, Warfarin-Controlled Phase II Study of Edoxaban in Japanese Patients With Non-Valvular Atrial Fibrillation

Abstract

Background: Edoxaban is a once-daily (QD) oral, direct factor Xa inhibitor in clinical development for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to evaluate the safety of edoxaban in Japanese patients with NVAF. Methods and Results: A total of 536 NVAF patients (CHADS2 ≥1) were randomized to receive double-blinded edoxaban 30, 45, or 60mg QD or open-label warfarin (international normalized ratio [INR] 2.0-3.0 for age Conclusions: Edoxaban 30, 45, and 60mg QD in patients with NVAF was associated with a numerical increase in all bleeding across the dose range, but this was not statistically significant, nor was any dose compared with warfarin. (Circ J 2012; 76: 1840–1847)