A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial
| Autor: | Nadia Rosencher, Piovella F, Paul A. Reilly, Rohan Hettiarachchi, Harry R. Büller, Bravo Ml, Ola E. Dahl, Peter Kälebo, Joachim Stangier, Lennart Ahnfelt, Bengt I. Eriksson |
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| Přispěvatelé: | ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine |
| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Pyridines Arthroplasty Replacement Hip medicine.medical_treatment Venography Administration Oral Knee replacement law.invention Dabigatran Postoperative Complications Double-Blind Method Randomized controlled trial Oral administration law Thromboembolism Odds Ratio medicine Humans Postoperative Period Enoxaparin Arthroplasty Replacement Knee Aged Aged 80 and over Dose-Response Relationship Drug medicine.diagnostic_test business.industry Thrombin Anticoagulants Hematology Odds ratio Middle Aged Arthroplasty Direct thrombin inhibitor Anesthesia Regression Analysis Benzimidazoles Female business medicine.drug |
| Zdroj: | Journal of thrombosis and haemostasis, 3(1), 103-111. Wiley-Blackwell |
| ISSN: | 1538-7836 1538-7933 |
| Popis: | Summary. Background: Dabigatran etexilate is an oral direct thrombin inhibitor undergoing evaluation for the prevention of venous thromboembolism (VTE) following orthopedic surgery. Methods: In a multicenter, parallel-group, double-blind study, 1973 patients undergoing total hip or knee replacement were randomized to 6–10 days of oral dabigatran etexilate (50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily), starting 1–4 h after surgery, or subcutaneous enoxaparin (40 mg once daily) starting 12 h prior to surgery. The primary efficacy outcome was the incidence of VTE (detected by bilateral venography or symptomatic events) during treatment. Results: Of the 1949 treated patients, 1464 (75%) patients were evaluable for the efficacy analysis. VTE occurred in 28.5%, 17.4%, 16.6%, 13.1% and 24% of patients assigned to dabigatran etexilate 50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily and enoxaparin, respectively. A significant dose-dependent decrease in VTE occurred with increasing doses of dabigatran etexilate (P |
| Databáze: | OpenAIRE |
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