Safety and Efficacy of Edoxaban, an Oral Factor Xa Inhibitor, for Thromboprophylaxis After Total Hip Arthroplasty in Japan and Taiwan

被引:47
作者
Fuji, T. [1 ]
Wang, C. -J. [2 ]
Fujita, S. [3 ]
Kawai, Y. [4 ]
Kimura, T. [5 ]
Tachibana, S. [6 ]
机构
[1] Osaka Hosp, Dept Orthopaed Surg, Japan Community Hlth Care Org, Osaka, Japan
[2] Chang Gung Univ, Coll Med, Kaohsiung Chang Gung Mem Hosp, Dept Orthoped Surg, Kaohsiung, Taiwan
[3] Takarazuka Daiichi Hosp, Dept Orthoped Surg, Takarazuka, Hyogo, Japan
[4] Int Univ Hlth & Welf, Tokyo, Japan
[5] Daiichi Sankyo Co Ltd, Clin Planning Dept, Tokyo, Japan
[6] Mishuku Hosp, Tokyo, Japan
关键词
edoxaban; factor Xa inhibitor; thromboembolic events; total hip arthroplasty; enoxaparin; TOTAL KNEE ARTHROPLASTY; VENOUS THROMBOEMBOLISM; REPLACEMENT; PREVENTION; WARFARIN;
D O I
10.1016/j.arth.2014.05.029
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Edoxaban, an oral direct factor Xa inhibitor, has proven antithrombotic efficacy. In a multicenter, phase II study, 264 total hip arthroplasty (THA) patients randomly received edoxaban 15 or 30 mg once daily or enoxaparin 2000 IU (20-mg) twice daily for 11-14 days. Thromboembolic event incidences were 3.8% (3/78), 2.8% (2/72), and 4.1% (3/74) for edoxaban 15-mg, 30-mg, and enoxaparin, respectively (P = 1.00). Edoxaban-induced prolongation of prothrombin time, international normalized ratio, and activated partial thromboplastin time were proportional to plasma edoxaban concentration. Major or clinically relevant non-major bleeding incidences were 2.2% (2/89), 1.2% (1/85), and 2.3% (2/87) for edoxaban 15-mg, 30-mg, and enoxaparin, respectively (P = 1.00). Once-daily edoxaban showed similar efficacy and safety to enoxaparin for prevention of thromboembolic events in patients undergoing THA. (c) 2014 The Authors. Published by Elsevier Inc.
引用
收藏
页码:2439 / 2446
页数:8
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