Daiichi Sankyo announced positive results from the Phase 3 ENGAGE AF-TIMI 48 study comparing once-daily edoxaban with warfarin in patients with non-valvular atrial fibrillation (NVAF) at moderate-to-high risk of thromboembolic events.
The study found that that edoxaban, a once-daily direct factor Xa-inhibitor, met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events in patients with NVAF. In addition, edoxaban achieved superiority for the principal safety endpoint by showing significant reduction in major bleeding compared to warfarin.
ENGAGE AF-TIMI 48 was a randomized, double-blind, double-dummy, global Phase 3 trial that compared edoxaban 60mg and 30mg vs. warfarin in patients with NVAF (n=21105). Patients in the edoxaban 60mg treatment arm had an annual incidence of stroke or SEE of 1.18% vs. 1.50% for warfarin (HR, 0.79; 97.5% CI, 0.63–0.99; P<0.001 for non-inferiority), and significantly reduced major bleeding by 20% (2.75% vs. 3.43% per year, respectively) (HR, 0.80; 95% CI, 0.71–0.91; P<0.001 for superiority).
The edoxaban 30mg treatment arm had an annual incidence of stroke or SEE of 1.61% vs. 1.50% for warfarin (HR, 1.07; 97.5% CI, 0.87–1.31; P=0.005 for non-inferiority), and significantly reduced major bleeding by 53% (1.61% vs. 3.43% per year, respectively) (HR, 0.47; 95% CI, 0.41–0.55; P<0.001 for superiority).
Late-breaking results from ENGAGE AF-TIMI 48 were presented at the AHA Scientific Sessions 2013 and published online in the New England Journal of Medicine.
For more information call (877) 437-7763 or visit DaiichiSankyo.com.