BUSINESS WIRE: Dabigatran Etexilate Shows Greater ...

BUSINESS WIRE: Dabigatran Etexilate Shows Greater Reductions Than Warfarin
in Stroke in

Patients with Atrial Fibrillation across All Stroke Risk Groups



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BERICHTENDE UNTERNEHMEN VERANTWORTLICH.
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* Compared to well-controlled warfarin, dabigatran etexilate provided
consistent benefits in stroke prevention in atrial fibrillation (AF),
irrespective of a patient’s risk profile for stroke^1 * Dabigatran
etexilate 150mg bid reduced the number of strokes in patients with AF
when compared to well-controlled warfarin, irrespective of a patient’s
risk profile^1 * Dabigatran etexilate 150mg bid and dabigatran etexilate
110mg bid were both associated with lower major bleeding rates when
compared with well-controlled warfarin in patients with AF at low risk
of stroke.^ 1

INGELHEIM, Germany --(BUSINESS WIRE)--15.03.2010--

Data presented today at the 59^th Annual Scientific Session of the American
College of Cardiology have shown greater reductions in stroke in patients
with atrial fibrillation (AF) for dabigatran etexilate^* compared to the
current standard of care, warfarin, irrespective of a patient’s risk
profile for stroke.^1 The new sub-group analysis from the landmark RE-LY^®
study^** assessed the rate of stroke and systemic embolism in patients
defined as being at low (n=5,775), moderate (n=6,455) and high (n=5,882)
risk of such events by the validated stroke risk stratification score,
CHADS[2].^1,2

The RE-LY^® sub-group analysis showed that dabigatran etexilate 150mg bid
reduced the rate of stroke and systemic embolism compared with
well-controlled warfarin, irrespective of a patient’s stroke risk.
Dabigatran etexilate 110mg bid resulted in similar reductions as
well-controlled warfarin. Both doses were associated with lower major
bleeding rates in patients at low risk of stroke.^1

In detail, the results showed:^1

* Dabigatran etexilate 150mg bid reduced the rate of stroke and systemic
embolism when compared with well-controlled warfarin across all stroke
risk groups with the relative risk (RR) being 0.62 (0.38?1.02) in low,
0.61 (0.40?0.92) in moderate, and 0.70 (0.52?0.95) in high risk
patients * Dabigatran etexilate 110mg bid showed similar reductions in
the rate of stroke and systemic embolism to well-controlled warfarin,
with RR being 1.00 (0.65?1.55) in low, 1.04 (0.73?1.49) in moderate and
0.79 (0.59?1.06) in high risk patients * Both doses of dabigatran
etexilate were associated with lower rates of major bleeding compared
to well-controlled warfarin in low risk patients (D110mg RR: 0.67
(0.49?0.90), D150mg RR: 0.73 (0.54?0.98)). * Consistent with the overall
RE-LY^® results both doses of dabigatran were associated with
substantial reductions in the rates of intracranial haemorrhage in all
risk groups.

Lead author Dr Jonas Oldgren, Uppsala University Hospital, Sweden said,
“For healthcare professionals treating patients with atrial fibrillation at
risk of stroke and systemic embolism, this sub-group analysis is very
encouraging as it shows that dabigatran etexilate 150mg bid is the first
treatment reducing strokes more than warfarin across the full spectrum of
stroke risk in patients with AF.”

Stroke risk stratification scores such as CHADS[2] have been developed to
guide appropriate use of anticoagulant therapy in patients with AF to
maximise its benefit.^2 For patients defined as being at high or moderate
risk of stroke, the reduction in stroke risk with vitamin K antagonists
(VKAs), such as warfarin, is likely to outweigh the risk of bleeding.^3 For
patients with a low risk CHADS[2 ]score, the benefits of VKAs are not as
clear. Therefore, currently many patients only receive Aspirin, which is
less effective than warfarin in reducing the risk of stroke, leaving
patients insufficiently protected from the threat of severe and highly
debilitating strokes.^4-7

Dr Jonas Oldgren continues, “Healthcare professionals and patients have
long been waiting for a treatment that can provide stroke prevention across
all levels of risk. We have shown that dabigatran etexilate provides
greater benefits in stroke reduction across patients at low, medium and
high risk, as well as reduced bleeding vs. warfarin in patients at low
risk. This provides important evidence of the clear benefit that this novel
oral anticoagulant can provide over current treatment with VKAs, such as
warfarin.”

Up to three million people worldwide suffer strokes related to AF each
year,^ 8-10 which tend to be especially severe and disabling,^8 with half
of people dying within one year.^11

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/
15_march_2010.html

^* Dabigatran etexilate (Pradaxa^®) is being investigated for the
prevention of stroke in patients with atrial fibrillation.

^** Randomized Evaluation of Long-Term Anticoagulant Therapy

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[CT]

Kontakt: Boehringer Ingelheim GmbH Dr. Reinhard Malin, +49/6132/77 35 82
Fax: +49/6132/77 66 01 press@boehringer-ingelheim.com

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