title: Safety and efficacy of edoxaban in patients undergoing hip fracture surgery.
abstract: BACKGROUND
  Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery.
  
  
  METHODS
  In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30mg once daily (n=62) or enoxaparin sodium (enoxaparin) 2000IU (equivalent to 20mg) twice daily (n=30) for 11 to 14days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study.
  
  
  RESULTS
  In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively.
  
  
  CONCLUSIONS
  Compared to subcutaneous enoxaparin 2000IU twice daily, oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery.
  
  
  BACKGROUND
  NCT01181141.
authors.affiliation: Department of Orthopaedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan. Electronic address: fuji-th@umin.ac.jp.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Fuji
authors.affiliation: Department of Orthopaedic Surgery, Takarazuka Daiichi Hospital, Takarazuka, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Fujita
authors.affiliation: International University of Health and Welfare, Tokyo, Japan.
authors.forename: Yohko
authors.initials: Y
authors.lastname: Kawai
authors.affiliation: Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, Tsu, Japan.
authors.forename: Mashio
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Clinical Planning Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Kimura
authors.affiliation: New Drug Regulatory Affairs Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Kiuchi
authors.affiliation: Clinical Data & Biostatistics Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Abe
authors.affiliation: Department of Orthopaedic Surgery, Mishuku Hospital, Tokyo, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Tachibana
mesh_terms: D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects*; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects*; D013923:Thromboembolism / Q000517:prevention & control
chemical_list: D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D011725:Pyridines; D013844:Thiazoles; C552171:edoxaban
keywords: Edoxaban; Enoxaparin; Factor Xa; Hip fracture surgery; Venous thromboembolism