LAVAL, QC, June 5 /CNW/ - Health Canada has approved PLAVIX(R)
(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
"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 attacks(1)," 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, COMMIT(2) and CLARITY-TIMI 28(3), 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 events.(4) 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(equals)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(equals)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(less than)0.001).(3)
"An estimated 53,000 Canadians(4) 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
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
Atherothrombosis is the underlying cause of life-threatening events such
as heart attacks and ischemic strokes.(6) 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 strokes.(7)
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 launch.(8)
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 years.(9) Two studies, CLARITY(3) and COMMIT(2),
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(less than)0.001), compared to the control group that only took standard
medication. In the COMMIT(2) trial, PLAVIX added to standard therapy, reduced
the risk of combination of death, recurrent heart attack or stroke by nine per
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
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
VIDEO B-ROLL AVAILABLE VIA SATELLITE:
DATE OF FEED: Tuesday, June 5, 2007
TIME OF FEED: 10:00 - 10:30 a.m. Eastern and again at 14:00 -
14:30 p.m. Eastern
CO-ORDINATES: Anik F2C/7B @ 111.1 West
Vertical Polarization, D/L Freq. 3980 MHz.
Audio subcarriers 6.8 left, 6.2 right
Also Available at Toronto T.O.C. at the same times (SDI Router Position
(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;
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.
For further information:
For further information: Jennifer Gordon, Caylyn Rodrigues, Edelman,
Tel.: (416) 979-1120, ext. 345, 395