Phase III data on Lixiana for VTE published in NEJM
Results from the global Phase III Hokusai-VTE study of 8,292 patients with either acute symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or both, found that Lixiana (edoxaban tosylate), from Daiichi Sankyo, met the primary efficacy endpoint of non-inferiority compared to warfarin for recurrent symptomatic Venous Thrombo Embolism (VTE). 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). 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).
Results from Hokusai-VTE were presented at the ESC Congress 2013 and published online in the New England Journal of Medicine. See: Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism." The Hokusai-VTE Investigators. NEJM September 1, 2013 DOI: 10.1056/NEJMoa1306638
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