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Schulman, S; Kearon, C; Kakkar, AK; Mismetti, P; Schellong, S; Eriksson, H; Baanstra, D; Schnee, J; Goldhaber, SZ; RE-COVER Study Group.
Dabigatran versus warfarin in the treatment of acute venous thromboembolism.
N Engl J Med. 2009; 361(24):2342-2352 Doi: 10.1056/NEJMoa0906598 [OPEN ACCESS]
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Study Group Members Med Uni Graz:: Pilger Ernst
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Abstract:: Background: The direct oral thrombin inhibitor dabigatran has a predictable anticoagulant effect and may be an alternative therapy to warfarin for patients who have acute venous thromboembolism. Methods: In a randomized, double-blind, noninferiority trial involving patients with acute venous thromboembolism who were initially given parenteral anticoagulation therapy for a median of 9 days (interquartile range, 8 to 11), we compared oral dabigatran, administered at a dose of 150 mg twice daily, with warfarin that was dose-adjusted to achieve an international normalized ratio of 2.0 to 3.0. The primary outcome was the 6-month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths. Safety end points included bleeding events, acute coronary syndromes, other adverse events, and results of liver-function tests. Results: A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2.4%), as compared with 27 of the 1265 patients randomly assigned to warfarin (2.1%), had recurrent venous thromboembolism; the difference in risk was 0.4 percentage points (95% confidence interval [CI], -0.8 to 1.5; P<0.001 for the prespecified noninferiority margin). The hazard ratio with dabigatran was 1.10 (95% CI, 0.65 to 1.84). Major bleeding episodes occurred in 20 patients assigned to dabigatran (1.6%) and in 24 patients assigned to warfarin (1.9%) (hazard ratio with dabigatran, 0.82; 95% CI, 0.45 to 1.48), and episodes of any bleeding were observed in 205 patients assigned to dabigatran (16.1%) and 277 patients assigned to warfarin (21.9%; hazard ratio with dabigatran, 0.71; 95% CI, 0.59 to 0.85). The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in the two groups. Adverse events leading to discontinuation of the study drug occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin (P=0.05). Conclusions: For the treatment of acute venous thromboembolism, a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring. (ClinicalTrials.gov number, NCT00291330.) N Engl J Med 2009;361:2342-52.
Find related publications in this database (using NLM MeSH Indexing): Administration, Oral -; Adolescent -; Adult -; Aged -; Aged, 80 and over -; Anticoagulants - adverse effects Anticoagulants - therapeutic use; Benzimidazoles - adverse effects Benzimidazoles - therapeutic use; Double-Blind Method -; Female -; Humans -; International Normalized Ratio -; Male -; Middle Aged -; Pyridines - adverse effects Pyridines - therapeutic use; Recurrence -; Risk -; Venous Thromboembolism - drug therapy; Warfarin - adverse effects Warfarin - therapeutic use; Young Adult -