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Once-Daily Edoxaban Reduces VTE Recurrence Compared With Warfarin in Phase III Study
Treatment also reduces clinically relevant bleeding (December 9)
Positive results have been reported from a subgroup analysis of 771 cancer patients enrolled in a phase III study evaluating the once-daily factor Xa inhibitor edoxaban (Daiichi Sankyo Company, Inc.) in patients with either a history of cancer (n = 563) or active cancer (n = 208). The findings were presented Dec. 9 at the 2013 American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans.
Treatment with once-daily edoxaban showed a numerically lower incidence of recurrent symptomatic venous thromboembolism (VTE) compared with warfarin (3.7% vs. 7.1%, respectively; hazard ratio [HR], 0.53). Edoxaban was also associated with a lower incidence of clinically relevant bleeding (major or non-major) compared with warfarin (12.4% vs. 18.8%, respectively; HR, 0.64).
These findings were consistent with the results from the total study population of 8,292 patients, in whom 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 with warfarin.
In a subset of 208 patients with active cancer who received once-daily edoxaban, the VTE recurrence rate was 3.7% compared with 7.1% for warfarin (HR, 0.55), and the incidence of clinically relevant bleeding was 18.3% compared with 25.3% for warfarin (HR, 0.72).
Source: Daiichi Sankyo, Inc.; December 9, 2013.