Pooled safety data for Pradaxa in DVT published-Boehringer

New pooled safety data from the RE-COVER and RE-COVER II Phase III trials of Pradaxa (dabigatran etexilate), from Boehringer, in acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism consistently favour treatment with Pradaxa 150mg bid over treatment with warfarin. The pooled data show a statistically significantly lower incidence of clinically relevant bleeding events and total bleeding for patients treated with heparin followed by Pradaxa compared to patients receiving heparin followed by warfarin. These data also show a trend towards reduction of major bleeding for Pradaxa (Pradaxa 150mg 1.4% vs. warfarin 2.0%). The primary efficacy endpoint of VTE or related death was comparable between the two treatments (Pradaxa 2.4% vs. warfarin 2.2%).

Pooled data for the treatment period after the end of the heparin treatment when patients were receiving only the oral study drugs show that versus warfarin patients treated with Pradaxa have statistically significantly lower rates of major bleeding events, clinically relevant bleeding and total bleeding events. The data are published in Circulation. See: "Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis." Schulman S, et al. Circulation online December 16 2013, doi:10.1161