A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II)
| Autor: | Sam Schulman, Ajay K. Kakkar, Eriksson Henry, Samuel Z. Goldhaber, Janet Schnee, Clive Kearon, Sebastian Schellong, Patrick Mismetti, Anita Vedel Christiansen |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Acute coronary syndrome Surrogate endpoint business.industry Immunology Warfarin Absolute risk reduction Cell Biology Hematology medicine.disease Lower risk Biochemistry Dabigatran law.invention Randomized controlled trial law Internal medicine medicine business Adverse effect medicine.drug |
| Zdroj: | Blood. 118:205-205 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood.v118.21.205.205 |
| Popis: | Abstract 205 Background: Dabigatran has been compared with warfarin for treatment of acute venous thromboembolism in one previous trial (RE-COVER). Based on the low rate of the primary outcome as the RE-COVER study was running, we undertook this replica study to confirm the results of RE-COVER, and to allow for more rigorous sub-group analyses. Methods: In a randomized, double-blind, double-dummy trial of 2568 patients with acute VTE, treated with low molecular weight or unfractionated heparin for 5 to 11 days, we compared dabigatran, 150 mg twice daily, with warfarin, dose-adjusted to an International Normalized Ratio of 2.0 and 3.0, each given for 6 months. Primary outcome was recurrent symptomatic, objectively confirmed venous thromboembolism and deaths related to venous thromboembolism during 6 months. Safety endpoints included bleeding events, acute coronary syndrome, elevated liver function tests, and adverse events. Results: Of 1279 patients randomized to dabigatran, 30 (2.4%) had recurrent VTE compared with 28 (2.2%) of 1289 patients randomized to warfarin; risk difference 0.2% (95% confidence interval [CI], −1.0 to 1.5); p Conclusion: The study confirms that the efficacy of dabigatran is non-inferior to warfarin in the treatment of acute VTE and with a lower risk for bleeding. The safety of dabigatran is similar in the Asian population compared with non-Asians. Disclosures: Off Label Use: dabigatran for treatment of venous thromboembolism. Christiansen:Boehringer Ingelheim: Employment. Schnee:Boehringer Ingelheim: Employment. |
| Databáze: | OpenAIRE |
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