Boehringer Ingelheim announced results from the RE-COVER II study evaluating dabigatran compared to warfarin in patients diagnosed with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
RE-COVER II was a randomized, double-blind, double-dummy study in patients (n=2,589) with acute symptomatic DVT and/or PE. The trial was designed to determine if dabigatran 150mg twice daily is non-inferior to warfarin and to compare the safety of the two drug regimens during six months of treatment. The primary efficacy endpoint was a composite of recurrent symptomatic VTE (DVT and/or PE) and related deaths.
The efficacy analysis included 2,568 patients (1,279 in the dabigatran group and 1,289 in the warfarin group) randomly assigned to the treatment groups where they received at least one dose of the study drug. The analysis showed that dabigatran was non-inferior to warfarin for the prevention of recurrent or fatal DVT and/or PE (P<0.001 for both hazard ratios and difference in absolute risk criteria). Recurrent nonfatal or fatal DVT and/or PE was confirmed after central adjudication in 30 patients in the dabigatran group (2.3%) and in 28 patients (2.2%) in the warfarin group (hazard ratio, 1.08; 95% CI, 0.64–1.80).
Dabigatran met the primary endpoint of noninferiority to warfarin for recurrent, symptomatic, objectively confirmed DVT and/or PE, and related deaths during six months of treatment. RE-COVER II also showed that dabigatran was associated with a 31% reduction in the risk of major bleeding (15 dabigatran vs. 22 warfarin patients), which did not reach statistical significance. Additionally, the study demonstrated significantly less overall bleeding (33% reduced risk; 200 dabigatran vs. 285 warfarin patients) and major or clinically relevant non-major bleeding (38% reduced risk; 64 dabigatran vs. 102 warfarin patients).
Pradaxa (dabigatran etexilate mesylate), a direct thrombin inhibitor, is already approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
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