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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

TOKYO, Sept. 1, 2013 /PRNewswire/ -- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced results from the global phase 3 Hokusai-VTE study of 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The study found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, following initial use of heparin in both arms, for the treatment and prevention of recurrent symptomatic venous thromboembolism (VTE). Once-daily edoxaban also demonstrated superiority compared to warfarin for the principal safety outcome of clinically relevant bleeding (the composite of major or clinically relevant non-major bleeding).1 Results from Hokusai-VTE were presented today at the ESC Congress 2013 in Amsterdam and published online in the New England Journal of Medicine.

The Hokusai-VTE study was designed to reflect clinical practice using a flexible treatment duration of three to 12 months, including initial heparin treatment, in a broad spectrum of VTE patients, including those with severe PE. For the primary efficacy outcome, edoxaban demonstrated non-inferiority with a numerically lower incidence of recurrent symptomatic VTE compared to warfarin (3.2% vs. 3.5%, respectively) (hazard ratio [HR], 0.89; 95% confidence interval [CI], 0.70 to 1.13; P<0.001 for non-inferiority).1 Edoxaban was also found to be superior to warfarin for the pre-specified principal safety outcome of clinically relevant bleeding (8.5% vs. 10.3%, respectively) (HR, 0.81; 95% CI, 0.71 to 0.94; P=0.004 for superiority).1

In the Hokusai-VTE study, patient specific dosing was applied according to the study protocol. Edoxaban was dosed at 60 mg once-daily, except for those patients with clinical factors that commonly impact response to
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SOURCE Daiichi Sankyo Company, Limited
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