INGELHEIM, Germany - Monday, December 10th 2012 [ME NewsWire]
In RE-LY®, patients had better survival prognosis and spent less time in intensive care following a major bleed with Pradaxa® (dabigatran etexilate) than with warfarin
Data provide further support for the favourable safety profile of Pradaxa®
Presentation at American Society of Hematology (ASH) 2012 highlighted as ‘Best of ASH’
(BUSINESS WIRE)-- For Non-US, Non-UK & Non-Canadian Media Only
Results from a new post-hoc analysis of the landmark RE-LY®i trial show that in patients experiencing a major bleeding event, treatment with Pradaxa® (dabigatran etexilate) was associated with lower mortality and a shorter length of stay in intensive care compared to warfarin. In a pooled post-hoc analysis of five Phase III trials with Pradaxa®, the data show a clear trend towards a better prognosis after a major bleed with Pradaxa® than with warfarin. These new data were presented at the American Society of Hematology (ASH) Annual Meeting 2012 in Atlanta, Georgia, USA.1 In the RE-LY® trial, rates of major bleeding events were similar with Pradaxa® 150 mg when compared to warfarin and significantly lower for Pradaxa® 110 mg.2,3
"Bleeding is a known possible treatment complication of all anticoagulant therapies. The results of our analysis indicate that patients who have a major bleeding while on treatment with dabigatran appear to have a better survival prognosis than those on warfarin,” said Prof. Sam Schulman, Division of Hematology and Thromboembolism, McMaster University, Hamilton, Canada. "The data also indicate that standard clinical support measures for patients with bleeding events work just as well in patients on dabigatran as for those on warfarin, and no greater use of medical resources is required.”
The new post-hoc analyses compare clinical management and outcomes following major bleeding events associated with both Pradaxa® and warfarin in the RE-LY® trial alone as well as in a pooled analysis of five Phase III studies in the indications for stroke prevention in non-valvular atrial fibrillation (AF), acute treatment as well as secondary prevention of venous thromboembolism (VTE). These trials had a duration of six to 36 months and included 26,757 patients.1 More patients in the Pradaxa® group had high risk factors compared to those in the warfarin group – they were older, had a lower creatinine clearance indicating a slightly worse kidney function, and had a more frequent use of acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs).1
For the RE-LY® trial, the adjustedii analysis of major bleeding with fatal outcomes showed a significantly lower mortality for patients treated with Pradaxa® compared to patients on warfarin (Odds Ratio 0.56 for dabigatran 150 mg + 110 mg vs. warfarin, p=0.009). Additionally, in RE-LY®, the length of stay in the intensive care unit (ICU) and coronary care unit (CCU) was significantly shorter for patients on Pradaxa® compared with those on warfarin (1.6 nights vs. 2.7 nights, p=0.01).1
In the pooled analysis of the five Phase III studies including AF and also VTE patients, the outcome across all trials showed a clear statistical trend (p=0.052, not significant) towards a lower 30-day mortality after the first major bleed associated with Pradaxa® compared to warfarin.1
"These analyses are important news for physicians and patients”, commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "They suggest that in the absence of a specific antidote patients treated with Pradaxa® may nonetheless expect better outcomes to those treated with warfarin should a major bleeding occur.”
The favourable benefit-risk profile of Pradaxa® is supported by safety assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).4,5 The latest FDA update reports the results of a Mini-Sentinel assessment that indicated the bleeding rates associated with new use of Pradaxa® are not higher than those associated with new use of warfarin. Specifically, for intracranial haemorrhage and gastrointestinal haemorrhage, the combined incidence rate (per 100,000 days at risk) was 1.8 to 2.6 times higher for new users of warfarin than for new users of Pradaxa®.5 Recently presented results from the RELY-ABLE® study indicate that the treatment effects and favourable safety profile of Pradaxa® are consistent over the long-term.6
iRE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110 mg and 150 mg bid) each administered in a blinded manner, with open label warfarin.3
iiAdjusted for sex, age, weight, renal function and additional antithrombotic therapy.
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/10_december_2012dabigatran.html
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