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PRoFESS(R) Results Announced at XVII European Stroke Conference
Date:5/14/2008

RIDGEFIELD, Conn., May 14 /PRNewswire/ -- Results of the PRoFESS(R) (Prevention Regimen For Effectively avoiding Second Strokes) trial -- the world's largest clinical research study for secondary stroke prevention -- were presented today at the XVII European Stroke Conference in Nice, France. In the study, recurrent stroke event rates for Aggrenox(R) and clopidogrel were similar (9.0% and 8.8%, respectively; HR 1.01, 95% CI 0.92-1.11). The study did not meet its primary endpoint of non-inferiority for AGGRENOX versus clopidogrel.(1)

In further exploratory analysis of the main secondary endpoint of the composite of stroke, myocardial infarction or vascular death, AGGRENOX and clopidogrel showed similar outcomes (13.1% versus 13.1%).(1)

In PRoFESS, the AGGRENOX arm had a higher number of hemorrhagic strokes compared to clopidogrel (0.8% and 0.4%, respectively) while ischemic stroke recurrences were less frequent in the AGGRENOX arm compared to the clopidogrel arm (7.7% and 7.9%, respectively).(1)

A post-hoc analysis showed comparable numbers of death and disabling strokes and a similar neurological outcome as measured by the modified Rankin Scale(2) at three months after the recurrent stroke and at the end of the PRoFESS trial between the two treatment arms.(1)

Major hemorrhagic events were observed more frequently in the AGGRENOX group compared with clopidogrel (4.1% versus 3.6%; HR 1.15, 95% CI 1.00-1.32). The benefit-risk ratio expressed as the combination of recurrent stroke and major hemorrhage was not significantly different between AGGRENOX and clopidogrel (11.7% and 11.4% respectively; HR 1.03, 95% CI 0.95-1.11).(1)

"Given the high prevalence of stroke and recurrent stroke in aging societies, physicians need a range of treatment options so they can offer patients a regimen tailored to their individual needs," said Professor Hans-Christoph Diener, MD, University of Essen, Germany, one of the three principal investigator
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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