Darexaban for the Prevention of Venous Thromboembolism in Asian Patients Undergoing Orthopedic Surgery: Results From 2 Randomized, Placebo-Controlled, Double-Blind Studies

作者：Fuji Takeshi^*; Nakamura Mashio; Takeuchi Masahiro

来源：Clinical and Applied Thrombosis/Hemostasis, 2014, 20(2): 199-211.

DOI：10.1177/1076029612457810

• deep venous thrombosis
• factor Xa inhibitors
• thrombosis prophylaxis
• pulmonary thromboembolism
• venous thromboembolism
• total joint arthroplasty

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 %26lt; .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 %26lt; .001). In both studies, the incidence of bleeding events was low across all treatment groups. Conclusion: Darexaban is effective and well tolerated as VTE prophylaxis in Asian patients undergoing elective major orthopedic surgery.

• 出版日期2014-3