The Journal of Arthroplasty
Volume 25, Issue 8 , Pages 1267-1274, December 2010

Dabigatran Etexilate Prevents Venous Thromboembolism After Total Knee Arthroplasty in Japanese Patients With a Safety Profile Comparable to Placebo

  • Takeshi Fuji, MD, PhD

      Affiliations

    • Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan
    • Corresponding Author InformationReprint requests: Takeshi Fuji, MD, PhD, Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, 4-2-78, Fukushima, Fukushima-ku, Osaka 553-0003, Japan.
    • ,
  • Satoru Fuijita, MD, PhD

      Affiliations

    • Department of Orthopedic Surgery, Takarazuka Daiichi Hospital, Takarazuka, Japan
    • ,
  • Toru Ujihira, MD, PhD

      Affiliations

    • Department of Cardiology, Okayama Red Cross General Hospital, Japan
    • ,
  • Toru Sato, MD, PhD

      Affiliations

    • Department of Orthopedic Surgery, National Hospital Organization, Okayama Medical Center, Japan

Received 27 February 2009; accepted 20 August 2009. published online 26 October 2009.

Abstract 

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.

Keywords: dabigatran etexilate, direct thrombin inhibitor, total knee arthroplasty, venous thromboembolism

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 Benefits or funds were received in particular or total support of the research material described in this article. These benefits and/or support were received from the following sources: Boehringer Ingelheim Co, Ltd (Kawanishi, Japan).

 Fuji is the coordinating investigator for Nippon Boehringer Ingelheim in this clinical study. Fujita is the chair of adjudication committee for diagnostic tests. Sato and Ujihira are consultants for Nippon Boehringer Ingelheim.

PII: S0883-5403(09)00410-0

doi:10.1016/j.arth.2009.08.010

The Journal of Arthroplasty
Volume 25, Issue 8 , Pages 1267-1274, December 2010

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