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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

sing was applied according to the study protocol. In both edoxaban treatment arms, the edoxaban dose was halved for patients with clinical factors that were known to increase the risk of bleeding (renal impairment, low body weight or concomitant use of certain P-glycoprotein inhibitors).1, 2 Patients receiving a reduced edoxaban dose in the 60 mg treatment arm had an annual incidence of stroke or SEE of 2.32% versus 2.68% for warfarin and a significantly reduced major bleeding incidence of 3.05% versus 4.85%. Patients receiving a reduced edoxaban dose in the 30 mg treatment arm had an annual incidence of stroke or SEE of 3.14% versus 2.68% for warfarin and a significantly reduced major bleeding incidence of 1.50% versus 4.85%.2

"The results from the ENGAGE AF-TIMI 48 trial showed that edoxaban may provide a new treatment option for the prevention of stroke or systemic embolic events that demonstrates comparable efficacy to warfarin, while significantly reducing the risk of major bleeding. In addition, we identified an appropriate dose regimen for patients with clinical factors such as renal impairment and low body weight," said Robert Giugliano, MD, SM, FAHA, FACC, Senior Investigator with the TIMI Study Group, Physician Cardiovascular Medicine, Brigham and Women's Hospital, Associate Professor of Medicine, Harvard Medical School, and Co-Global Lead Investigator of the ENGAGE AF-TIMI 48 trial. "In conducting this landmark trial we sought to provide clinicians with robust data, evident by the trial size and follow-up, high percentage of time in therapeutic range for the warfarin treatment arm, and very low rate of missing data. In addition, we specifically designed a comprehensive transition plan to protect patients from the undue risk of stroke and bleeding when switching to open-label anticoagulation at the end of the trial."

"The edoxaban clinical trial program, the largest in the history of Daiichi
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