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. CONCLUSION:Darexaban is effective and well tolerated as VTE prophylaxis in Asian patients undergoing elective major orthopedic surgery.
RCT Entities:
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. CONCLUSION:Darexaban is effective and well tolerated as VTE prophylaxis in Asian patients undergoing elective major orthopedic surgery.
Entities:
Keywords:
deep venous thrombosis; factor Xa inhibitors; pulmonary thromboembolism; thrombosis prophylaxis; total joint arthroplasty; venous thromboembolism
Authors: A Kapoor; A Ellis; N Shaffer; J Gurwitz; A Chandramohan; J Saulino; A Ishak; T Okubanjo; F Michota; E Hylek; T A Trikalinos Journal: J Thromb Haemost Date: 2017-01-19 Impact factor: 5.824
Authors: David R Anderson; Gian Paolo Morgano; Carole Bennett; Francesco Dentali; Charles W Francis; David A Garcia; Susan R Kahn; Maryam Rahman; Anita Rajasekhar; Frederick B Rogers; Maureen A Smythe; Kari A O Tikkinen; Adolph J Yates; Tejan Baldeh; Sara Balduzzi; Jan L Brożek; Itziar Etxeandia- Ikobaltzeta; Herman Johal; Ignacio Neumann; Wojtek Wiercioch; Juan José Yepes-Nuñez; Holger J Schünemann; Philipp Dahm Journal: Blood Adv Date: 2019-12-10