The New England Journal of Medicine has published findings from the RE-MEDY and RE-SONATE trials investigating dabigatran etexilate (Pradaxa, Boehringer Ingelheim) in the long-term prevention of deep vein thrombosis (DVT) or pulmonary embolism (PE). The results demonstrate that Pradaxa 150mg twice daily is an effective option with a favourable safety profile for the extended prevention of recurrence of these venous blood clots after a first event.
In the RE-SONATE trial, dabigatran reduced the risk of recurrent events of deep vein thrombosis or pulmonary embolism by 92% compared with placebo. In the RE-MEDY trial, dabigatran 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.
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 dabigatran 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.
“The new results from RE-MEDY and RE-SONATE suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said Sam Schulman, Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Canada. “They reinforce the efficacy and favourable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”
Details on RE-MEDY and RE-SONATE
The new findings were derived from two double-blind randomised studies – RE-MEDY and RE-SONATE – investigating dabigatran in the long-term prophylaxis of recurrence after an initial DVT or PE. Enrolled patients had completed at least three months of acute treatment. In RE-MEDY, 2,856 patients were randomised and received dabigatran or warfarin for an extended treatment period of up to 36 months. In RE-SONATE, 1,343 patients were randomised and received dabigatran or placebo for six months, extended follow-up to evaluate the long-term risk of recurrence took place 12 months after completion of study treatment.
Dabigatran is currently not approved for the acute treatment or secondary prevention of DVT and PE.