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Today, the New England Journal of Medicine published findings from the RE-MEDYTM and RE-SONATETM trials investigating Pradaxaή (dabigatran etexilate) in the long-term prevention of deep vein thrombosis (DVT) or pulmonary embolism (PE). The results demonstrate that Pradaxa 150 mg twice daily is an effective option with a favourable safety profile for the extended prevention of recurrence of these venous blood clots (known as venous thromboembolism or VTE) after a first event.i
In the RE-SONATETM trial, Pradaxaή reduced the risk of recurrent events of deep vein thrombosis or pulmonary embolism by 92% compared with placebo.1 In the RE-MEDYTM trial, 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.1
Additional follow-up data from the RE-SONATETM trial presented at the American Society for Hematology (ASH) Congress 2012 showed that the treatment benefit of Pradaxaή 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.4
DVT and PE are venous thrombotic events triggered by a blood clot blocking blood vessels.5,6 Venous thromboembolism is estimated to be the third most common cardiovascular disorder after coronary heart disease and stroke.7 Over 750,000 venous thrombotic events are estimated to occur annually in six major European countries (France, Germany, Italy, Spain, Sweden, UK)8 and over 900,000 events occur annually in the US.9 Data has shown that the risk of recurrent VTE can increase cumulatively in patients who are not treated with standard therapy from 11% after one year to up to 40% after 10 years.10 Therefore, long-term preventive treatment may be of benefit.
‘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,’ says Professor 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-MEDYTM and RE-SONATETM
The new findings were derived from two double-blind randomised studies – RE-MEDYTM and RE-SONATETM – investigating Pradaxa 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-MEDYTM, 2,856 patients were randomised and received Pradaxaή or warfarin for an extended treatment period of up to 36 months. In RE-SONATETM, 1,343 patients were randomised and received Pradaxa 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.
Key results from the two double-blind randomised trials show:1
Efficacy1RE-SONATETM: 92% risk reduction for recurrent DVT or PE with Pradaxaή vs. placebo: 0.4% vs. 5.6% (P