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New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of PLAVIX(R) in Acute Coronary Syndrome Patients Undergoing Angioplasty
Date:8/29/2009

r patients taking the higher dose regimen (600 mg loading / 150 mg for days 2-7 / 75 mg days 8-30) over the standard dose regimen (300 mg loading / 75 mg for days 2-30), as shown by the reduction of the same composite end-point of cardiovascular death, myocardial infarction and stroke by 15% (4.5% vs 3.9%, p=0.037). In addition, analysis showed an important 42% relative risk reduction in definite stent thrombosis (1.2% vs 0.7%, p=0.001) with the higher dose regimen of clopidogrel over the standard loading dose.

"An artery opening procedure with stent placement exposes a patient to an increased risk of stent occlusion and subsequent heart attack," said Doctor Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. "CURRENT-OASIS 7 provides important new information about a high-dose regimen of PLAVIX((R)) in ACS patients planned for PCI. We are pleased to contribute to furthering the understanding of patient care during the acute phase of coronary intervention."

The primary safety end-point was assessed by the stringent bleeding definition of OASIS and while a significant increase in the primary safety end-point of major bleeding with the high-dose compared to the standard-dose PLAVIX((R)) regimen was observed in the overall trial population (2.5% vs 2.0%, HR 1.25, p=0.01) and the PCI population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no statistically significant difference in intracranial bleeding or fatal hemorrhage in the overall population and the PCI population.

Sanofi-aventis and Bristol-Myers Squibb believe that the CURRENT-OASIS 7 data add to the broad clinical experience with PLAVIX((R)), which has been used in over 90 million patients during the 11 years it has been on the market.

About PLAVIX((R) )(clopidogrel bisulfate)

Please see full prescribing information for the United States by visiting '/>"/>

SOURCE sanofi-aventis; Bristol-Myers Squibb
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