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PRoFESS(R) Results Announced at XVII European Stroke Conference

Thursday, May 15, 2008 General News J E 4
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RIDGEFIELD, Conn., May 14 Results of the PRoFESS(R)(Prevention Regimen For Effectively avoiding Second Strokes) trial -- theworld'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) andclopidogrel were similar (9.0% and 8.8%, respectively; HR 1.01, 95% CI0.92-1.11). The study did not meet its primary endpoint of non-inferiority forAGGRENOX versus clopidogrel.(1)

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

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

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

Major hemorrhagic events were observed more frequently in the AGGRENOXgroup 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 andmajor hemorrhage was not significantly different between AGGRENOX andclopidogrel (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 agingsocieties, physicians need a range of treatment options so they can offerpatients a regimen tailored to their individual needs," said ProfessorHans-Christoph Diener, MD, University of Essen, Germany, one of the threeprincipal investigators of the study. "Landmark trials like PRoFESS will helpclinicians make evidence-based treatment choices and ensure that patientsreceive optimal therapy for their condition."

The other regimen tested in PRoFESS investigated whether Micardis(R)tablets, combined with standard antiplatelet therapy, can further reduce therisk of recurrent stroke. At the end of the study, the results demonstratedthat 8.7% of patients experienced recurrent stroke in the MICARDIS arm versus9.2% in the placebo arm (p=0.23). Thus, the primary endpoint of superiorityof MICARDIS versus placebo could not be statistically confirmed. The meanfollow-up period was 2.5 years, and it is unclear whether a longer follow-upperiod would have yielded statistical significance. The PRoFESS resultscontinue to support the safety and tolerability profile of MICARDIS.

"We are proud to have sponsored the PRoFESS study," said Dr. Thor Voigt,Senior Vice President, Medicine and Drug Regulatory Affairs, BoehringerIngelheim Pharmaceuticals, Inc. "We set out to advance the understanding ofstrategies for recurrent stroke prevention and will continue to evaluate thePRoFESS data to help physicians make more informed treatment decisions."

About PRoFESS(R)

PRoFESS(R) (Prevention Regimen For Effectively avoiding Second Strokes)was designed to examine the effects of different prevention regimens onrecurrent stroke, including the antiplatelet agent AGGRENOX versus clopidogreland the efficacy of MICARDIS, an antihypertensive, compared to placebo inpreventing recurrent stroke in the presence of background standardantihypertensive therapy. The trial was a randomized, double-blind,placebo-controlled clinical study that included 20,332 patients from 695 sitesin 35 countries, with a four-year follow-up of patients.

PRoFESS is a collaborative effort between academia and the sponsor,Boehringer Ingelheim. Co-funders of the telmisartan arm of the study inselected countr
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