New findings from two studies support substantial benefit of Pradaxa® for prevention of recurrent deep vein thrombosis and pulmonary embolism

INGELHEIM, Germany--(BUSINESS WIRE)--For Non-US, Non-UK & Non-Canadian Media Only

Today, the New England Journal of Medicine published findings from the RE-MEDY^TM and RE-SONATE^TM trials investigating Pradaxa^®(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-SONATE^TM trial, Pradaxa^® reduced the risk of recurrent events of deep vein thrombosis or pulmonary embolism by 92% compared with placebo.¹ In the RE-MEDY^TMtrial, 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-SONATE^TM 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.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-MEDY^TM and RE-SONATE^TM

The new findings were derived from two double-blind randomised studies – RE-MEDY^TM and RE-SONATE^TM – 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-MEDY^TM, 2,856 patients were randomised and received Pradaxa^®or warfarin for an extended treatment period of up to 36 months. In RE-SONATE^TM, 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

Efficacy¹

RE-SONATE^TM: 92% risk reduction for recurrent DVT or PE with Pradaxa^® vs. placebo: 0.4% vs. 5.6% (P<0.001 for superiority)
RE-MEDY^TM: Pradaxa^®demonstrated comparable efficacy to warfarin with a low frequency of recurrent DVT or PE: 1.8% vs. 1.3% (P=0.01 for non-inferiority)

Safety¹

Low overall bleeding rates seen with Pradaxa^® in both trials with major bleeds occurring in two patients in RE-SONATE^TM and 13 patients in RE-MEDY^TM out of over 2,000 patients receiving Pradaxa^®
RE-MEDY^TM: Pradaxa^® showed a 46% lower risk of clinically relevant bleeding (including major bleeding) vs. warfarin:
- Significantly lower clinically relevant bleeding (including major bleeding) with Pradaxa^® vs. warfarin: 5.6% vs. 10.2% (relative risk reduction 46%, P<0.001)
- Trend towards lower risk of major bleeding alone: 0.9% vs. 1.8% (relative risk reduction 48%, P=0.06)
RE-SONATE^TM:
- Number of patients with a major bleed: 2 patients with Pradaxa^® vs. 0 patient with placebo
- Higher rate of major or clinically relevant bleeding vs. placebo (5.3% vs. 1.8%; P= 0.001)
In RE-SONATE^TM, comparable rates of acute coronary syndrome (ACS) were observed in Pradaxa^® and placebo (0.1% vs. 0.2%), while in RE-MEDY^TM, a higher rate of ACS events was observed in the Pradaxa^® group (13 patients, 0.9%) vs. warfarin (3 patients, 0.2%)

The efficacy and safety profile of Pradaxa^® in its licensed indications to prevent stroke and systemic embolism in patients with atrial fibrillation (AF) and to prevent venous blood clots following elective hip- or knee-replacement surgery is well documented in an extensive clinical trial programme^11-16, which led to worldwide regulatory approvals in over 80 countries to date.¹⁷ Clinical experience with Pradaxa^® continues to grow and equates to over 1.3 million patient-years in all licensed indications to date.¹⁷

Pradaxa^® is currently not approved for the acute treatment or secondary prevention of DVT and PE.

ⁱ Important Notice: Pradaxa^® (dabigatran etexilate) is currently not approved for the acute treatment or secondary prevention of deep vein thrombosis and pulmonary embolism.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/21_february_2013dabigatranetexilate.html