We assessed the efficacy, safety, and dose-response of dabigatran etexilate (DAB) in preventing venous thromboembolism (VTE) in Japanese patients undergoing total knee arthroplasty (TKA). Five hundred twelve patients received DAB (110, 150, or 220 mg) or placebo once daily for 11 to 14 days, starting the day after surgery. The primary efficacy end point was the incidence of total VTE and all-cause mortality; the primary safety end point was incidence of major, clinically relevant, and minor bleeding events. Total VTE and all-cause mortality were lower in patients receiving DAB (39.6%, 32.7%, and 24.0%) than placebo (56.4%). There was no difference in the incidence of major bleeding between the DAB and placebo groups. Overall, DAB reduced the incidence of VTE in Japanese patients undergoing TKA, with a comparable safety profile vs placebo.
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