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Dabigatran (Pradaxa) Superior to Warfarin in Patients With Thrombosis or Embolism

Phase III study shows reduced bleeding (December 17)

Positive results have been reported from the RE-COVER II study evaluating dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) compared with warfarin in patients with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). In this phase III trial, published online in Circulation, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively confirmed DVT and/or PE and related deaths during 6 months of treatment.

The RE-COVER II trial also showed that dabigatran was associated with a 31% reduction in the risk of major bleeding (15 dabigatran patients vs. 22 warfarin patients), but this difference did not reach statistical significance. In addition, the study demonstrated significantly less overall bleeding (33% reduced risk: 200 dabigatran patients vs. 285 warfarin patients) and major or clinically relevant non-major bleeding (38% reduced risk: 64 dabigatran patients vs. 102 warfarin patients).

RE-COVER II was a randomized, double-blind, double-dummy study involving 2,589 patients with acute symptomatic DVT and/or PE. The trial was designed to determine whether dabigatran 150 mg twice daily was non-inferior to warfarin for the primary endpoint of preventing the recurrence of DVT and/or PE and related deaths, and to compare the safety of the two drug regimens during 6 months of treatment.

The efficacy analysis included 2,568 patients. All of the patients received at least one dose of the study drug (1,279 in the dabigatran group and 1,289 in the warfarin group). 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 the difference in absolute risk criteria). Specifically, recurrent nonfatal or fatal DVT and/or PE was confirmed in 30 patients (2.3%) in the dabigatran group and in 28 patients (2.2%) in the warfarin group (hazard ratio, 1.08).

Pradaxa (dabigatran etexilate mesylate) is currently approved in the U.S. to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; dabigatran is not approved for the treatment of DVT and/or PE.

Source: Boehringer Ingelheim; December 17, 2013.

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