ME Newswire / Businesswire
INGELHEIM, Germany - Tuesday, November 19th 2013
Pradaxa® (dabigatran etexilate) is the only novel oral
anticoagulant with more than 6 years of long-term data supporting its
beneficial role for stroke prevention in atrial fibrillation1
The efficacy and safety profiles of both doses of Pradaxa® during
up to 6.7 years of extended treatment remain consistent with the
pivotal results seen in the registration trial RE-LY®1,2,3
Presented during the American Heart Association's Scientific
Sessions, new data add to the body of evidence for Pradaxa®
For media outside of the US, the UK & Canada only
Results from a new combined analysis of the pivotal Phase III RE-LY®
trial and its extension study RELY-ABLE® show that, in long-term
treatment, the efficacy and safety profiles of both doses of Pradaxa®
(dabigatran etexilate, 150mg bid and 110mg bid) remain consistent with
the results seen in the 18,000 patient-strong RE-LY® registration
trial.1,2,3 The new data were presented during the American Heart
Association’s Scientific Sessions 2013.
“This is important news for physicians and patients who use either dose
of dabigatran etexilate to reduce the lifetime risk of stroke
associated with atrial fibrillation,” said Prof. Michael D. Ezekowitz,
Thomas Jefferson Medical College, Philadelphia, USA. “They can feel
reassured that dabigatran etexilate will provide sustained stroke
prevention and a favourable long-term safety profile.”
The combined analysis includes all patients from RE-LY® and RELY-ABLE®
who were treated with either Pradaxa® 150mg bid or Pradaxa® 110mg bid.
Median follow-up lasted an average of 4.6 years, with maximum follow-up
extending to 6.7 years in several hundred patients. The new findings
show that for Pradaxa®:1
The rates of stroke or systemic embolism were 1.25 and 1.54 percent
/ year on dabigatran 150mg bid and 110mg bid respectively
The rates of ischaemic stroke were 1.03 and 1.29 percent / year
on dabigatran 150mg bid and 110mg bid respectively
The rates of haemorrhagic stroke were 0.11 and 0.13 percent /
year on dabigatran 150mg bid and 110mg bid respectively
The rates of major haemorrhage were 3.34 and 2.76 percent / year on
dabigatran 150mg bid and 110mg bid respectively
The safety profile was consistent over time, with no new safety
issues identified compared to the original RE-LY® results
“These unique long-term treatment results presented during the AHA
Scientific Sessions show consistent safety and efficacy profiles for
both doses of Pradaxa® over more than 6 years of clinical follow-up,”
said Professor Klaus Dugi, Corporate Senior Vice President Medicine,
Boehringer Ingelheim. “Among the novel oral anticoagulants, such long-
term data are only available for Pradaxa®. Especially for a chronic
condition that requires life-long treatment like stroke prevention in
atrial fibrillation, results such as these provide key insights for
physicians and patients.”
The favourable efficacy-safety 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
Clinical experience with Pradaxa® continues to grow and equates to over
two million patient-years in all licensed indications to date.6
Pradaxa® is the longest studied novel oral anticoagulant.6
Pradaxa® is currently approved in over 100 countries worldwide for the
prevention of stroke and systemic embolism in patients with non-
valvular atrial fibrillation and for the primary prevention of venous
thromboembolism following total hip replacement or total knee
replacement surgery.6,7
~ENDS~
Please click on the link for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-
ingelheim.com/news/news_releases/press_releases/2013/19_november_2013_d
abigatranetexilate.html
Contacts
Boehringer Ingelheim Corporate Communications Media + PR
Sara McClelland
Phone: +49 6132 – 77 8271
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
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