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Daiichi Sankyo's Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial
Date:11/19/2013

DALLAS and TOKYO, Nov. 19, 2013 /PRNewswire/ -- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced results today from the phase 3 ENGAGE AF-TIMI 48 study.1 This clinical trial found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Once-daily edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint. Results from ENGAGE AF-TIMI 48 were presented today as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas and published online in the New England Journal of Medicine.2

ENGAGE AF-TIMI 48 compared two edoxaban treatment arms, 60 mg and 30 mg, with warfarin in 21,105 patients with NVAF for a median of 2.8 years. This represents the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date. The edoxaban 60 mg treatment arm had an annual incidence of stroke or SEE of 1.18% versus 1.50% for warfarin (hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 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 to 0.91; p<0.001 for superiority). The edoxaban 30 mg treatment arm had an annual incidence of stroke or SEE of 1.61% versus 1.50% for warfarin (HR, 1.07; 97.5% CI, 0.87 to 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 to 0.55; p<0.001 for superiority).2

In ENGAGE AF-TIMI 48, patient-specific do
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