INGELHEIM, Germany - Wednesday, November 19th 2014 [ME NewsWire]
American Heart Association’s Scientific Sessions 2014: Latest real-world data once again reinforce benefits from Pradaxa®1,2
Two
new analyses involving over 60,000 US patients in total show that
Pradaxa® was linked to fewer major bleeds and strokes than warfarin1,2
Results shown in RE-LY® clinical study supported by data from different patient populations in general practice1-4
(BUSINESS WIRE) - For Non-US/Non-UK/Non-Canadian Media
Two
new real-world data analyses presented at the American Heart
Association’s Scientific Sessions 2014 independently demonstrate that
routine treatment with Pradaxa® (dabigatran etexilate) was associated
with fewer major bleeds and strokes compared to warfarin.1,2 The results
of both studies, which involved over 60,000 atrial fibrillation (AF)
patients in the US, demonstrate that the safety and effectiveness
profile of Pradaxa® treatment seen during the RE-LY® clinical trial can
be achieved in broad patient populations receiving routine clinical care
for stroke prevention.1-4 One analysis was conducted by the Brigham and
Women’s Hospital, using commercial US health insurance databases,1 and
the second analysis was conducted by the Walter Reed National Military
Medical Center, using the US Department of Defense Military Health
System database.2 In the US, the licensed doses for dabigatran etexilate
are 150mg twice daily and 75mg* twice daily to reduce the risk of
stroke and systemic embolism in adult patients with non-valvular atrial
fibrillation.5
Interim findings from Dr. John D. Seeger from the
Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical
School, showed that treatment with Pradaxa® led to a significant 25 per
cent reduction of major bleeding compared to warfarin and a numerical 23
per cent reduction in stroke. The data were derived from 38,378 AF
patients in two commercial US health insurance databases (MarketScan and
Optum).1
Similar results were seen in the second real-world study
presented at the congress by Lieutenant Colonel Todd C. Villines,
Cardiology Service, Walter Reed National Military Medical Center.
Treatment with Pradaxa® was associated with significantly fewer strokes
(27 per cent less) and fewer major bleeds (13 per cent less,
numerically) than warfarin treatment. In addition, significantly more
major lower gastrointestinal bleeding (30 per cent more), significantly
fewer myocardial infarctions (35 per cent less), and a significantly
improved survival (36 per cent better) were observed in patients taking
Pradaxa®. The data were analysed from the US Department of Defense
Military Health System database which included over 25,000 AF patients.2
“Real-world
data are extremely valuable to physicians as they provide insights on
how the efficacy-safety profile of a medicine is reflected in different
patient populations in general practice,” said Prof. Jörg Kreuzer,
Practicing Cardiologist and Vice President Medicine Therapeutic Area
Cardiovascular, Boehringer Ingelheim. “We are pleased by these latest
results as they show that the safety and efficacy profile of Pradaxa®
originally established in the RE-LY® clinical trial can also be achieved
in routine care worldwide.”
The results from the two new studies
presented at the American Heart Association’s Scientific Sessions 2014
show a similar pattern to the real-world results from the recent
Medicare assessment published by the U.S. Food and Drug Administration
(FDA) which included more than 134,000 AF patients who were 65 years of
age or older. All three large real-world analyses which involved a total
of over 190,000 AF patients from different populations reaffirm the
efficacy and safety profile of Pradaxa® for stroke prevention over
warfarin in everyday routine care.1,2,7
The full abstracts can be accessed online:
http://www.abstractsonline.com/pp8/#!/3547/presentation/41579
http://www.abstractsonline.com/pp8/#!/3547/presentation/37812
*
In the US, 75mg twice daily is indicated for patients with a creatinine
clearance between 30 and 15 ml/min.5 The dose of 75mg twice daily is
not authorised in Europe for this indication.6
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/19_november_2014dabigatranetexilate.html
Contacts
Boehringer Ingelheim GmbH
Friederike Middeke
Phone: +49 6132 – 77 141 575
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com
Twitter: http://twitter.com/Boehringer
www.boehringer-ingelheim.com
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