title: Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III randomized, mechanical prophylaxis-controlled, open-label study.
abstract: BACKGROUND
  Darexaban (YM150) is an oral direct factor Xa inhibitor in clinical development for prophylaxis of venous thromboembolism (VTE) after major orthopaedic surgery. The objective of this study was to assess the efficacy and safety of darexaban 15 mg twice daily (bid) in Japanese patients undergoing major abdominal surgery.
  
  
  METHODS
  In a Phase III, multicentre, randomized, open-label, mechanical prophylaxis-controlled, parallel-group study, adult patients (aged ≥ 40 years) were randomized to darexaban 15 mg bid or mechanical prophylaxis, for 28 days. The primary efficacy outcome was incidence of total VTE at Day 12. Adverse events (AEs) and bleeding events were recorded throughout the study.
  
  
  RESULTS
  The total VTE incidence at Day 12 was 2.6% in the darexaban 15 mg bid group (95% confidence interval [CI]: 0.32, 9.07), compared with 15.0% (95% CI: 5.71, 29.84) in the mechanical prophylaxis group. During the investigational period, the incidence of all bleeding events was 9.5% in the darexaban 15 mg bid group and 3.9% in the mechanical prophylaxis group. In the darexaban 15 mg bid group, one patient experienced major bleeding and five patients experienced clinically relevant non-major (CRNM) bleeding. No patients in the mechanical prophylaxis group experienced major and/or CRNM bleeding. AEs were reported in 71.4% of patients in the darexaban 15mg bid group and 76.5% of patients in the mechanical prophylaxis group; the most frequent AEs across both treatment groups were constipation and insomnia. No patients died during the study.
  
  
  CONCLUSIONS
  Based on these findings, darexaban is expected to be effective for the prevention of VTE in patients undergoing major abdominal surgery. (
  
  
  BACKGROUND
  NCT00942435).
authors: Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan. sakon@nishi.or.jp
authors: Masato
authors: M
authors: Sakon
authors: Mashio
authors: M
authors: Nakamura
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000368:Aged; D044466:Asian People; D001381:Azepines / Q000627:therapeutic use*; D001549:Benzamides / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D065427:Factor Xa Inhibitors; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D008297:Male; D061185:Mechanical Thrombolysis; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000009:adverse effects*; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D001381:Azepines; D001549:Benzamides; D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; C569750:darexaban