title: Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan.
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.
authors.affiliation: Department of Orthopaedic Surgery, Japan Community Health care Organization Osaka Hospital, Osaka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Fuji
authors.affiliation: Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: C-J
authors.initials: CJ
authors.lastname: Wang
authors.affiliation: Department of Orthopedic Surgery, Takarazuka Daiichi Hospital, Hyogo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Fujita
authors.affiliation: International University of Health and Welfare, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kawai
authors.affiliation: Clinical Planning Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Mishuku Hospital, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Tachibana
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D004311:Double-Blind Method; D017984:Enoxaparin / Q000008:administration & dosage; D065427:Factor Xa Inhibitors / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage*; D013624:Taiwan; D013844:Thiazoles / Q000008:administration & dosage*; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000991:Antithrombins; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D011725:Pyridines; D013844:Thiazoles; C552171:edoxaban
keywords: edoxaban; enoxaparin; factor Xa inhibitor; thromboembolic events; total hip arthroplasty