Sanofi-aventis; Bristol-Myers Squibb
New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of PLAVIX(R) in Acute Coronary Syndrome Patients Undergoing Angioplasty
Paris, and Princeton, New Jersey (ots/PRNewswire)
-No added benefit on the composite primary end-point with the higher dose when entire ACS study population considered-
-Important new findings with higher loading dose of PLAVIX(R) for heart patients undergoing coronary angioplasty (PCI)-
Today, the OASIS study group will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY) and Bristol-Myers Squibb (NYSE: BMY), co-commercialization and co-development partners for PLAVIX(R) (clopidogrel bisulfate), were sponsors of the study.
CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing regimens of PLAVIX(R) plus aspirin in a broad range of acute coronary syndrome (ACS) patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen (600 mg loading dose day 1 / 150 mg days 2-7 / 75 mg days 8-30) versus the approved PLAVIX dosage (300 mg loading dose day 1 / 75 mg days 2-30) for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI).
The primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population (including subpopulations of patients that underwent PCI (70%) or not (30%) examining the difference between the high-dose and standard-dose PLAVIX(R) (clopidogrel bisulfate) regimens did not reach statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37).
For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population, 17,232 patients), potentially medically relevant differences in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome for 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 www.PLAVIX.com. For the most updated PLAVIX(R) labelling information in Europe please refer to: http://www.emea.europa.eu/humandocs/PDFs/EPAR/PLAVIX/H-174-PI-en.pdf.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
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Sanofi-aventis
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Bristol-Myers Squibb
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical trials described in this release will support a regulatory filing. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact:
Ingrid Gorg-Armbrecht, Media, +33-153-774-625, Mobile:
+33-686-056-688, or ingrid.goerg-armbrecht@sanofi-aventis.com,
Sebastien Martel, Investors, +33-153-774-545, or
ir@sanofi-aventis.com, both of sanofi-aventis; Laura Hortas, Media,
+1-609-240-7025, or laura.hortas@bms.com , John Elicker, Investors,
+1-609-252-4611, or john.elicker@bms.com, both of Bristol-Myers
Squibb