alexa Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Haematology

Haematology

Journal of Blood Disorders & Transfusion

Author(s): Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H,

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Abstract BACKGROUND: Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism. METHODS: In two double-blind, randomized trials, we compared dabigatran at a dose of 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months of therapy. RESULTS: In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8\%) and 18 of 1426 patients in the warfarin group (1.3\%) (hazard ratio with dabigatran, 1.44; 95\% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9\%) and 25 patients in the warfarin group (1.8\%) (hazard ratio, 0.52; 95\% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent with dabigatran (hazard ratio, 0.54; 95\% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9\%) and 3 patients in the warfarin group (0.2\%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4\%) and 37 of 662 patients in the placebo group (5.6\%) (hazard ratio, 0.08; 95\% CI, 0.02 to 0.25; P<0.001). Major bleeding occurred in 2 patients in the dabigatran group (0.3\%) and 0 patients in the placebo group. Major or clinically relevant bleeding occurred in 36 patients in the dabigatran group (5.3\%) and 12 patients in the placebo group (1.8\%) (hazard ratio, 2.92; 95\% CI, 1.52 to 5.60). Acute coronary syndromes occurred in 1 patient each in the dabigatran and placebo groups. CONCLUSIONS: Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo. (Funded by Boehringer Ingelheim; RE-MEDY and RE-SONATE ClinicalTrials.gov numbers, NCT00329238 and NCT00558259, respectively.). This article was published in N Engl J Med and referenced in Journal of Blood Disorders & Transfusion

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