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

Journal of Arthroplasty

Volumn 25, Issue 8, 2010, Pages 1267-1274

  Fuji, Takeshi ^a   Fuijita, Satoru ^b   Ujihira, Toru ^c   Sato, Toru ^d  

^a OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^b Takarazuka Daiichi Hospital   (Japan)

^c Japanese Red Cross Okayama Hospital   (Japan)

^d NATIONAL HOSPITAL ORGANIZATION   (Japan)

Author keywords

Dabigatran etexilate; Direct thrombin inhibitor; Total knee arthroplasty; Venous thromboembolism

Indexed keywords

DABIGATRAN ETEXILATE; PLACEBO;

ADULT; AGED; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; AGED; ARTHROPLASTY, REPLACEMENT, KNEE; BENZIMIDAZOLES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FIBRINOLYTIC AGENTS; HUMANS; JAPAN; MALE; MIDDLE AGED; PYRIDINES; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM;

EID: 78249262614     PISSN: 08835403     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.arth.2009.08.010     Document Type: Article

References (18)

1. Chotanaphuti T., Ongnamthip P., Silpipat S., et al. The prevalence of thrombophilia and venous thromboembolism in total knee arthroplasty. J Med Assoc Thai 2007, 90:1342.
2. Geerts W.H., Pineo G.F., Heit J.A., 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.
5. Kobayashi T., Nakamura M., Sakuma M., et al. Incidence of pulmonary thromboembolism (PTE) and new guidelines for PTE prophylaxis in Japan. Clin Hemorheol Microcirc 2006, 35:257.
6. Editorial Committee on Japanese Guideline for Prevention of Venous Thromboembolism Japanese Guideline for Prevention of Venous Thromboembolism 2004, Medical Front International Ltd, Tokyo, Japan, [in Japanese].
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.
8. Wienen W., Stassen J.M., Priepke H., et al. In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate. Thromb Haemost 2007, 98:155.
9. Liesenfeld K.H., Schäfer H.G., Trocóniz I.F., et al. Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis. Br J Clin Pharmacol 2006, 62:527.
10. Stangier J., Eriksson B.I., Dahl O.E., et al. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol 2005, 45:555.
11. Eriksson B.I., Dahl O.E., 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 B.I., Dahl O.E., 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.
13. EMEA EPARs for authorised medicinal products for human use 2008 Available at, (accessed 18 August 2008). http://www.emea.europa.eu/humandocs/Humans/EPAR/pradaxa/pradaxa.htm.
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 2000, the European Agency for the Evaluation of Medicinal Products, London, Guideline no. CPMP/EWP/707/98, (accessed January 14, 2008). http://www.emea.europa.eu/pdfs/human/ewp/070798en.pdf.
16. Sakon M., Maehara Y., Yoshikawa H., et al. Incidence of venous thromboembolism following major abdominal surgery: a multi-center, prospective epidemiological study in Japan. J Thromb Haemost 2006, 4:581.
17. Eriksson B.I., Quinlan D.J. Oral anticoagulants in development: focus on thromboprophylaxis in patients undergoing orthopaedic surgery. Drugs 2006, 66:1411.
18. Dahl O.E., Eriksson B.I., Caprini J.A., et al. Extended duration of thromboprophylaxis with dabigatran etexilate (DE) after TKR surgery reduces the frequency of DVT. Pathophysiol Haemos Thromb 2007/2008, 36(Suppl 1):A16.