Non-inferior with respect to recurrent symptomatic venous thromboembolism; superior for bleeding
WEDNESDAY, Sept. 4 (HealthDay News) -- For patients with venous thromboembolism, treatment with edoxaban is non-inferior to warfarin with respect to recurrent symptomatic venous thromboembolism and is associated with significantly less bleeding, according to a study published online Sept. 1 in the New England Journal of Medicine to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 31 to Sept. 4 in Amsterdam.
Harry R. Büller, M.D., from the University of Amsterdam, and colleagues conducted a randomized, non-inferiority study in which 4,921 patients with deep vein thrombosis and 3,319 with a pulmonary embolism who had initially received heparin were randomized to receive edoxaban at 60 mg or 30 mg once daily or to receive warfarin for three to 12 months.
The researchers found that for the primary efficacy outcome of recurrent symptomatic venous thrombosis, edoxaban was non-inferior to warfarin (3.2 and 3.5 percent respectively; P < 0.001 for non-inferiority). For the safety outcome of major or clinically relevant non-major bleeding, edoxaban was superior to warfarin (8.5 versus 10.3 percent; hazard ratio, 0.81; P = 0.004).
"Edoxaban administered once daily after initial treatment with heparin was non-inferior to high-quality standard therapy and caused significantly less bleeding in a broad spectrum of patients with venous thromboembolism, including those with severe pulmonary embolism," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Daiichi-Sankyo, which funded the study.
Full Text (http://www.nejm.org/doi/full/10.1056/NEJMoa1306638#t=article )More Information (http://www.escardio.org/ESC2013 )