title: Darexaban for the prevention of venous thromboembolism in Asian patients undergoing orthopedic surgery: results from 2 randomized, placebo-controlled, double-blind studies.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of darexaban (YM150) in Asian patients undergoing total hip or total knee arthroplasty.
  
  
  METHODS
  In 2 phase II/III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, patients were randomized to oral darexaban 15 mg twice daily (bid), darexaban 30 mg bid, oral placebo bid, or subcutaneous enoxaparin 20 mg bid. Primary efficacy outcome for both studies was total venous thromboembolism (VTE) incidence.
  
  
  RESULTS
  Both darexaban doses were statistically significantly superior to placebo for total VTE incidence (hip study: darexaban 15 mg bid [2.9%] vs placebo [17.1%], P < .001; darexaban 30 mg bid [5.2%] vs placebo [17.1%], P = .003; and knee study: darexaban 15 mg bid [27.2%] vs placebo [52.8%], P = .002; darexaban 30 mg bid [15.5%] vs placebo [52.8%], P < .001). In both studies, the incidence of bleeding events was low across all treatment groups.
  
  
  CONCLUSIONS
  Darexaban is effective and well tolerated as VTE prophylaxis in Asian patients undergoing elective major orthopedic surgery.
authors.affiliation: 1Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, Fukushima-ku, Osaka, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Fuji
authors.forename: Mashio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
mesh_terms: D000328:Adult; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000379:methods*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000379:methods*; D044466:Asian People; D001381:Azepines / Q000008:administration & dosage* / Q000009:adverse effects; D001549:Benzamides / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D019637:Orthopedic Procedures / Q000009:adverse effects / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000188:drug therapy / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D001381:Azepines; D001549:Benzamides; D017984:Enoxaparin; C569750:darexaban