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Daiichi Sankyo's Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
Date:8/31/2013

oral anticoagulants (renal impairment, low body weight, or concomitant use of certain p-glycoprotein inhibitors) who received edoxaban 30 mg according to the study protocol. The reduced dose of edoxaban was found to have an efficacy profile consistent with the overall study cohort, with fewer recurrent VTE events in patients receiving 30 mg edoxaban (n=733) compared to warfarin (n=719) (VTE recurrence of 3.0% vs. 4.2%; HR, 0.73; 95% CI, 0.42 to 1.26). Clinically relevant bleeding in patients receiving edoxaban 30 mg was significantly lower compared to warfarin (7.9% vs. 12.8%, respectively) (HR, 0.62; 95% CI, 0.44 to 0.86).1

Among patients with DVT (n=4,921), VTE recurrence was similar in the edoxaban and warfarin groups (3.4% vs. 3.3%, respectively) (HR, 1.02; 95% CI, 0.75 to 1.38), while the incidence of recurrent VTE among patients with PE (n=3,319) was numerically lower for patients treated with once-daily edoxaban compared to warfarin (2.8% vs. 3.9%, respectively) (HR, 0.73; 95% CI, 0.50 to 1.06). Additionally, in a sub-group analysis, patients with severe PE and evidence of right ventricular dysfunction (defined as NT pro-BNP >/= 500 pg/mL, n=938) treated with edoxaban had a 48% lower risk of recurrent symptomatic VTE compared to warfarin (3.3% vs. 6.2%, respectively) (HR, 0.52; 95% CI, 0.28 to 0.98).1

"Hokusai-VTE was designed to include a broad range of VTE patients, including those with severe pulmonary embolism, and we are therefore pleased that the study found that edoxaban administered once-daily is as efficacious as warfarin for the prevention of recurrent symptomatic VTE while significantly reducing the risk of bleeding," said Harry Büller, MD, PhD, Professor of Internal Medicine, Chairman of the Department of Vascular Medicine at the Academic Medical Center in Amsterdam, The Netherlands and Chairman of the Hokusai-VTE steering committee. "A promising finding was the sizeable re
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SOURCE Daiichi Sankyo Company, Limited
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