Daiichi reports Phase III VTE data for edoxaban

Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) said once-daily edoxaban plus heparin met the primary efficacy endpoint of non-inferiority to warfarin plus heparin in the Phase III Hokusai-VTE trial to treat and prevent recurrence of acute symptomatic venous thromboembolism (VTE) in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). Specifically, edoxaban plus heparin was non-inferior to warfarin plus heparin in reducing the incidence of recurrent symptomatic VTE, defined as a composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE (3.2% vs. 3.5%, p<0.001 for non-inferiority).

On the primary safety endpoint, the rate of clinically relevant bleeding was significantly lower for edoxaban compared to warfarin (8.5% vs. 10.3%, p=0.004). The double-blind, international trial enrolled 8,292 patients with acute symptomatic DVT, PE or both. Data were published in the New England Journal of Medicine and presented at the European Society of Cardiology meeting in Amsterdam. ...