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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

ar mortality rates versus warfarin: the incidence was 3.17% for warfarin, 2.74% (p=0.013) for the edoxaban 60 mg treatment arm and 2.71% (p=0.008) for the edoxaban 30 mg treatment arm. The primary net clinical outcome (defined in the study protocol as the composite of death, stroke, SEE or major bleeding) was 8.11% per year for warfarin, 7.26% per year for the edoxaban 60 mg treatment arm (p=0.003) and 6.79% per year for the edoxaban 30 mg treatment arm (p<0.001).2

About ENGAGE AF-TIMI 48

ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA next GEneration in Atrial Fibrillation) was a three-arm, randomized, double-blind, double-dummy, global phase 3 clinical trial comparing once-daily edoxaban with warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events at 1,393 centers in 46 countries.2

Patients were randomized (1:1:1) to receive warfarin (n=7,036), edoxaban 60 mg (n=7,035) or edoxaban 30 mg (n=7,034). Edoxaban dosage was reduced by half if any of the following was present at randomization or during the course of the study: creatinine clearance 30-50 mL/min, body-weight < or = 60 kg, or concomitant verapamil, quinidine or dronedarone (standard dosing was resumed if the concomitant drug was discontinued and no other dose reduction factors were present). The primary efficacy outcome was the time to first adjudicated stroke or SEE. The principal safety outcome was adjudicated major bleeding. Complete information on the primary endpoint was ascertained for 99.5% of the total 56,346 patient-years of potential follow-up, with only one patient lost to follow-up. Warfarin therapy was proactively monitored throughout the trial, resulting in a median time within therapeutic range (TTR) of 68.4%. Adverse event (excluding bleeding) and discontinuation rates were similar among the three treatment groups.2

ENGAGE AF-TIMI 48 implemented a unique, pre-specified plan to trans
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