Navigation Links
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

PARIS, and PRINCETON, N.J., Aug. 30 /PRNewswire/ -- 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.

Statement on Cautionary Factors

Sanofi-aventis

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

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.


'/>"/>
SOURCE sanofi-aventis; Bristol-Myers Squibb
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention
2. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
3. Dr. Roger Kenneth Hershline PhD MD, CEO of Global Humanceuticals, Inc. Donates New HIV Drug
4. Directors Forum: PEPFAR and the Global AIDS Response
5. Alfacell Corporation to Present at UBS Global Life Sciences Conference
6. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
7. Global HIV Vaccine Enterprise Names Alan Bernstein as Inaugural Executive Director, Opens New Secretariat
8. President Clinton Highlights MWW Group at the 2007 Clinton Global Initiative for its Stop Neglected Tropical Disease Campaign
9. Hillary Clinton Pledges Bold Approach to Stopping HIV/AIDS & Global Poverty
10. IBA and Elekta Initiate Global Particle Therapy Program at ASTRO
11. Dr. Rajeev Venkayya Joins Gates Foundation as Director of Global Health Delivery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/17/2017)... NEW YORK , Feb. 17, 2017  Noble ... coverage on ESSA Pharma Inc. (Nasdaq: EPIX ... Biotechnology Research, Kumar Raja , PhD. ... treatments for castration resistant prostate cancer (CRPC). Its lead ... selectively blocks the amino-terminal domain of the androgen receptor, ...
(Date:2/16/2017)... Quest Diagnostics (NYSE: DGX ), ... announced that it has been named one of the ... The annual survey designated Quest Diagnostics as ... Pharmacy and Other Services" industry to attain Most Admired ... attain the designation. This is the second consecutive year ...
(Date:2/16/2017)... , Feb. 16, 2017  Aralez Pharmaceuticals Inc. ... specialty pharmaceutical company, today announced that executive management will ... to be held February 22-23, 2017. Adrian Adams ... the Company at 1:35 p.m. local time on Wednesday, ... audio archive for the event may be accessed from ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... February 17, 2017 , ... For ... assistance management solution to the exhibit floor for the 2017 HIMSS Conference ... , From Feb. 19–23, 2017, more than 40,000 healthcare industry professionals are expected ...
(Date:2/17/2017)... Seattle, WA (PRWEB) , ... February 17, 2017 ... ... health management organizations, has been named a finalist in the 8th Annual DecisionHealth ... impacting America's healthcare delivery system. Qualis Health’s work is recognized across multiple award ...
(Date:2/17/2017)... ... 2017 , ... Pharmica Consulting attended CHI's 8th Annual SCOPE ... trial planning and management. Pharmica discussed the importance of effective project management, data ... by Pharmica’s booth were able to demo its cloud-based Resource Management Tool, ...
(Date:2/17/2017)... ... February 17, 2017 , ... Top neuroendocrine cancer doctors, nurses and specialists from ... February 21 - 23 in Beaver Creek, CO. It was announced today by Cindy ... year in Beaver Creek, hosting over 60 faculty members and addressing unmet needs of ...
(Date:2/16/2017)... ... 17, 2017 , ... For some cancer survivors, the memories ... Physician researchers at The Marcus Institute of Integrative Health at Thomas Jefferson ... reducing symptoms of traumatic stress in cancer patients and published their results ...
Breaking Medicine News(10 mins):