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Health Canada's Approval of an Expanded Indication for Plavix® (Clopidogrel Bisulfate) Now Offers Protection from All Types of Heart Attacks

Categories: Cardiovascular | Plavix

LAVAL (QUEBEC), CANADA – (June 5, 2007)Health Canada has approved PLAVIX® (clopidogrel bisulfate) in combination with ASA to reduce the rate of all-cause mortality and the rate of a combined endpoint of death, re-infarction, or stroke in patients with acute ST-segment elevation myocardial infarction (STEMI). PLAVIX is now indicated to reduce the risk of heart attack, stroke or death in patients with all acute coronary syndromes (ACS).

“This new indication is an important advance in the treatment of ACS for patients with STEMI as myocardial infarction is a life-threatening condition. Previously, clopidogrel taken with aspirin was shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks1,” said Dr. Shamir R. Mehta, Associate Professor of Medicine and Director of Interventional Cardiology and the Acute Coronary Syndrome Research Program, Population Health Research Institute, McMaster University and Hamilton Health Sciences. “Now, based on the positive results of two clinical trials, COMMIT2 and CLARITY-TIMI 283, clopidogrel has been approved for use with aspirin in patients with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndromes.”

In 2005, more than 186,000 Canadians were hospitalized due to ACS. Of this, more than 124,000 were heart attack cases and over 53,000 or 43 per cent were STEMI events4. Patients who have experienced STEMI are at high-risk of another heart attack, stroke or death. STEMI is considered to be the most severe form of heart attack.

The Health Canada approval was based on the results of two clinical trials of more than 48,000 patients in which STEMI patients treated with PLAVIX taken with aspirin and standard therapy were compared to STEMI patients treated with placebo taken with aspirin and standard therapy. In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) trial conducted in China, patients were followed for up to 28 days while in the CLARITY - TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY – Thrombolysis In Myocardial Infarction Study 28) multi-national trial, patients were followed for 30 days.

Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by seven per cent (event rate: 7.5% vs. 8.1%; P=0.03), and reduced the relative risk of the combination of death, MI, stroke by nine per cent (event rate: 9.2% vs. 10.1%; P=0.002)2. In the CLARITY - TIMI 28 trial, clopidogrel taken with aspirin and other standard therapy including thrombolytics significantly reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by thirty-six per cent by day eight of hospitalization or discharge (event rate: 15.0% in clopidogrel arm vs. 21.7% in placebo: 95% CI 0.53, 0.76, p<0.001)3.

“An estimated 53,000 Canadians4 suffer STEMI events each year, and survivors are at high risk of suffering another atherothrombotic event,” said Dr. Mehta. “The results of the COMMIT and CLARITY-TIMI 28 trials represent a major advance for patients who have had the most severe form of heart attack, and this indication for clopidogrel provides clinicians with a new option for STEMI patients to reduce their risk of a having a recurrent heart attack, stroke or death.”

ABOUT STEMI AND ACUTE CORONARY SYNDROME

Acute ST-segment elevation myocardial infarction (STEMI), along with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) are the three conditions classified as acute coronary syndrome (ACS). ACS is a major cause of emergency medical care and hospitalization in Canada.

In secondary prevention with early and long-term use, PLAVIX has been shown to decrease the rate of atherothrombotic events (cardiovascular death, MI, ischemic stroke, refractory ischemia) when taken in combination with ASA in patients with ACS without ST segment elevation (unstable angina or non-Q-wave myocardial infarction) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or coronary artery bypass graft surgery (CABG)5.

For patients with ST-segment elevation acute myocardial infarction (STEMI), PLAVIX has been shown to reduce the rate of an endpoint of all-cause mortality and the rate of a combined endpoint of death, re-infarction or stroke5.

ABOUT ATHEROTHROMBOSIS

Atherothrombosis is the underlying cause of life-threatening events such as heart attacks and ischemic strokes6. It is a progressive disease process, which begins with the unpredictable and sudden rupture of an atherosclerotic plaque. The rupture of these plaques activates platelets in the blood to form a clot (thrombus) and it is these clots, which can partially or completely block arteries, which may result in atherothrombotic events such as heart attacks or ischemic strokes7.

ABOUT PLAVIX

PLAVIX is an antiplatelet medication that helps keep platelets in the blood from sticking together to form blood clots – a process called atherothrombosis – that can restrict blood flow in arteries to important parts of the body (e.g., heart or brain)5.

The clinical benefit of the new STEMI indication reinforces the strong commitment of two research and development pharmaceutical companies dedicated to improving patient health. PLAVIX has been studied through landmark clinical trials in 100,000 patients and with clinical experience in 52 million patients treated worldwide since its launch8.

PLAVIX has demonstrated early risk reduction for patients at risk for atherothrombotic events in important clinical trials. In the CURE trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) receiving PLAVIX with aspirin were followed for up to one year,1 and in the CAPRIE trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease receiving PLAVIX alone were followed for up to three years9. Two studies, CLARITY3 and COMMIT2, demonstrated benefits of PLAVIX combined with standard therapy. In the CLARITY 3 trial, PLAVIX users, in combination with standard therapy, reduced their odds of the primary efficacy endpoint (composite of an occluded infarct-related artery or death or recurrent MI) by 36 per cent (p<0.001), compared to the control group that only took standard medication. In the COMMIT2 trial, PLAVIX added to standard therapy, reduced the risk of combination of death, recurrent heart attack or stroke by nine per cent.

About sanofi-aventis

Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

In Canada, sanofi-aventis employs more than 1,000 people and is headquartered in Laval, Quebec.

About Bristol-Myers Squibb

Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.

For more information, please contact:

Jennifer Gordon
Tel.: (416) 979-1120, ext. 345

Caylyn Rodrigues Edelman
Tel.: (416) 979-1120, ext. 395

References

1 CURE (The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial) collaborative group. Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes Without ST-Segment Elevation. New England Journal of Medicine 2001; 345: 494-502.
2 COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607–21.
3 Sabatine M, et al. Addition of Clopidogrel to Aspirin and Fibrinolytic Therapy for Myocardial Infarction with ST- Segment Elevation. NEJM 2005; 352.
4 Based on CIHI 2005 and GRACE 2006 as referenced on slide 12 of the ACS Expansion Plan CWG December 14, 2006.
5 PLAVIX Product Monograph, 2007-02-20. sanofi-aventis.
6
Viles-Gonzalez JF, et al. Atherothrombosis: A widespread disease with unpredictable and life-threatening consequences. Eur Heart J 2004; 25: 1197-1207.
7 Athrothrombosis.org. http://www.atherothrombosis.org/public/index.html. Last accessed May 1, 2007.
8 Data on File, sanofi-aventis.
9
CAPRIE (The Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events Trial) collaborative group. Superiority of Clopidogrel Versus Aspirin in Patients with Prior Cardiac Surgery. Circulation 2001; 363-368.

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