Pulmonary Embolism

January 6, 2014

Daiichi Sankyo has released results of phase III trials of edoxaban for the treatment of either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both, in cancer and non-cancer patients. The global, event-driven, randomized, double-blind, parallel-group phase III study involved 8,292 patients in 439 clinical sites across 37 countries. Patients with either a history of cancer (n=563) or with active cancer (n=208) treated with the once-daily factor Xa-inhibitor edoxaban had a numerically lower incidence of recurrent symptomatic venous thromboembolism (VTE) compared to warfarin (3.7% v. 7.1%, respectively; hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.28 to 1.00). Once-daily edoxaban also had a lower incidence of clinically relevant bleeding (major or non-major) compared to warfarin in cancer patients (12.4% v. 18.8%, respectively; HR, 0.64; 95% CI, 0.45 to 0.92). In the subset of 208 patients with active cancer, once-daily edoxaban had a rate of VTE recurrence of 3.7% compared to 7.1% for warfarin (HR, 0.55; 95% CI, 0.16 to 1.85) and an incidence of clinically relevant bleeding of 18.3% compared to 25.3% for warfarin (HR, 0.72; 95% CI, 0.40 to 1.30).