Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan
T Fuji, C-J Wang, S Fujita, Y Kawai, T Kimura, S Tachibana, T Fuji, C-J Wang, S Fujita, Y Kawai, T Kimura, S Tachibana
Abstract
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 2000IU (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.
Trial registration: ClinicalTrials.gov NCT01203098.
Keywords: edoxaban; enoxaparin; factor Xa inhibitor; thromboembolic events; total hip arthroplasty.
Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed