Edoxaban effective in cancer patients with VTE-Daiichi Sankyo

Daiichi Sankyo Company, Limited announced results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase III Hokusai-VTE study.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% vs. 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% vs. 18.8%, respectively; HR, 0.64; 95% CI, 0.45 to 0.92). These findings are consistent with the results from the wider study population of 8,292 patients, which found once-daily edoxaban met the primary efficacy endpoint of non-inferiority for the treatment and prevention of VTE and superiority for the pre-specified principal safety outcome of clinically relevant bleeding compared to warfarin. The data from this subgroup analysis of the phase III Hokusai-VTE study were presented at the 2013 American Society of Hematology Annual Meeting and Exposition in New Orleans.

In cancer patients, there is a significantly increased risk of VTE compared to the general population due to proteins released by malignant tumours that promote coagulation.

Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopedic surgery.