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Efficacy and Safety of Edoxaban for Treatment of Venous Thromboembolism: A Subanalysis of East Asian Patients in the Hokusai-VTE Trial.
J Thromb Haemost. 2015 Jul 15;
Authors: Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H
Abstract
BACKGROUND: Direct oral anticoagulants have been evaluated for their efficacy and safety in the treatment of venous thromboembolism (VTE), which comprises deep vein thrombosis and pulmonary embolism. The randomized, double-blind Hokusai-VTE trial demonstrated that once-daily edoxaban 60 mg following initial heparin treatment is noninferior for the treatment of VTE and is associated with significantly fewer bleeding events compared with heparin overlapped with and followed by warfarin.
OBJECTIVES: To assess the efficacy and safety of edoxaban vs warfarin among East Asian patients enrolled in the Hokusai-VTE trial.
PATIENTS/METHODS: The Hokusai-VTE trial enrolled 8292 patients from 439 centers worldwide, including 1109 patients from Japan, China, Korea, and Taiwan. The primary efficacy and safety outcomes were symptomatic recurrent VTE and clinically relevant bleeding, respectively.
RESULTS: In the overall East Asian population, the primary efficacy outcome of symptomatic recurrent VTE occurred in 16/563 (2.8%) patients in the edoxaban group vs 24/538 (4.5%) patients in the warfarin group (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.34-1.19; P = 0.1601). The primary safety outcome of clinically relevant bleeding occurred in 56/563 (9.9%) patients in the edoxaban group vs 93/538 (17.3%) patients in the warfarin group (HR 0.56; 95% CI, 0.40-0.78; P <0.001).
CONCLUSIONS: Edoxaban is an effective and safer alternative to warfarin in East Asian patients with acute VTE who require anticoagulant therapy, consistent with overall study findings from the Hokusai-VTE trial. This article is protected by copyright. All rights reserved.
PMID: 26179767 [PubMed - as supplied by publisher]