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.

References 

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  2. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126:338S
  3. Fuji T, Fujita S, Ochi T. Fondaparinux prevents venous thromboembolism after joint arthroplasty surgery in Japanese patients. Int Orthop. 2008;32:443
  4. Fuji T, Ochi T, Niwa S, et al. Prevention of postoperative venous thromboembolism in Japanese patients undergoing total hip or knee arthroplasty: 2 randomized, double-blind, placebo-controlled studies with 3 dosage regimens of enoxaparin. J Orthop Sci. 2008;13:442
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  7. Fujita S, Hirota S, Oda T, et al. Deep venous thrombosis after total hip or total knee arthroplasty in patients in Japan. Clin Orthop Relat Res. 2000;375:168
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  11. Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5:2178
  12. Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949
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  14. The RE-MOBILIZE Writing Committee . The oral thrombin inhibitor dabigatran etexilate vs the North American enoxaparin regimen for the prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty. 2009;24:1
  15. Committee for Proprietary Medicinal Products . Points to consider on clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk. London: the European Agency for the Evaluation of Medicinal Products; 2000;Guideline no. CPMP/EWP/707/98 http://www.emea.europa.eu/pdfs/human/ewp/070798en.pdf(accessed January 14, 2008)
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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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