TY - JOUR
T1 - Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism
AU - Bueller, Harry R.
AU - Decousus, Herve
AU - Grosso, Michael A.
AU - Mercuri, Michele
AU - Middeldorp, Saskia
AU - Prins, Martin H.
AU - Raskob, Gary E.
AU - Schellong, Sebastian M.
AU - Schwocho, Lee
AU - Segers, Annelise
AU - Shi, Minggao
AU - Verhamme, Peter
AU - Wells, Phil
PY - 2013/10/10
Y1 - 2013/10/10
N2 - Background Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. MethodsIn a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. ResultsA total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P
AB - Background Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. MethodsIn a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. ResultsA total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P
U2 - 10.1056/NEJMoa1306638
DO - 10.1056/NEJMoa1306638
M3 - Article
C2 - 23991658
SN - 0028-4793
VL - 369
SP - 1406
EP - 1415
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 15
ER -