Positive trials results for Boehringer Ingelheim's Pradaxa for prevention of recurrent DVT and PE

Findings from the RE-MEDY and RE-SONATE trials investigating German family-owned drug major Boehringer Ingelheim’s already marketed Pradaxa (dabigatran etexilate) in the long-term prevention of deep vein thrombosis (DVT) or pulmonary embolism (PE) demonstrate that Pradaxa 150mg twice daily is an effective option with a favorable safety profile for the extended prevention of recurrence of these venous thromboembolism (VTE) after a first event.

Reported in the New England Journal of Medicine, in the RE-SONATE trial, Pradaxa reduced the risk of recurrent events of deep vein thrombosis or pulmonary embolism by 92% compared with placebo. In the RE-MEDY study, Pradaxa compared to warfarin showed a 46% lower risk of clinically relevant bleeding (including major bleeding) while the protection from recurrent VTE was similar to warfarin. However, compared with placebo, dabigatran resulted in more bleeding episodes.

Additional follow-up data from the RE-SONATE trial presented at the American Society for Hematology (ASH) Congress 2012 showed that the treatment benefit of Pradaxa® for prevention of recurrent DVT and PE is maintained when a one-year-period after the end of the treatment is included in the analysis.