ACC ANNOUNCEMENT

Cure Study Shows Clopidogrel Reduces Risk of Heart Attack, Stroke and Cardiovascular Death

Early and Long-Term Use of clopidogrel is Found to Be Beneficial in Patients with Unstable Angina and Non Q-Wave Myocardial Infarction (Mild Heart Attack)

ORLANDO, Florida (March 19, 2001) - Results from an international clinical trial announced today demonstrate that initiating therapy with the antiplatelet medicine clopidogrel, early and continuing long-term, significantly reduces the risk of CV death, heart attack and stroke by 20% in patients with acute coronary syndrome (unstable angina and non-Q wave myocardial infarction [NQMI], also referred to as "mild heart attack"). The results were presented today at the 50 th annual American College of Cardiology Scientific Sessions, held in Orlando, Florida.

"The CURE study provides important new findings which constitute a major step forward and could lead to a very significant improvement in the treatment of patients at risk of heart attack, stroke and cardiovascular death," said study chair and principal investigator Dr. Salim Yusuf, MBBS, DPhil, Professor of Medicine and Director of the division of Cardiology at McMaster University, Hamilton, Canada.

Unstable angina and NQMI are serious and life threatening conditions. In unstable angina, the blood supply to the heart is significantly reduced, and urgent and effective intervention is required to stop these patients from progressing to a complete heart attack. The benefit of clopidogrel was seen within two hours of treatment, and continuously increased over the entire study duration of 12 months.

"These results mark a major advance in both the immediate and long-term management of patients with acute coronary syndrome," said Dr. Yusuf. "The findings show that up to 28 major life threatening events could be prevented per 1,000 patients over nine months by using clopidogrel on top of current standard therapy including aspirin in this patient population, while only six individuals per thousand experienced a bleed which required a transfusion. The results also confirm clopidogrel's excellent safety profile."

The high morbidity and mortality of acute coronary syndrome underscores the value of these results in both the early and long-term benefit noted. CURE ( C lopidogrel in U nstable Angina to Prevent R ecurrent Ischemic E vents) is the largest study ever conducted in people with unstable angina or NQMI. It is a randomized, double-blind trial conducted in 12,562 patients across 482 hospitals in 28 countries. The results of the CURE study show that clopidogrel on top of standard therapy, including effective therapies such as aspirin (acetylsalicylic acid or ASA), reduces the risk of atherothrombotic events (including heart attack, stroke and cardiovascular death) by 20% compared to those receiving standard therapy alone (p<0.001). Clopidogrel demonstrated benefit that was incremental to and independent of other therapies which patients may have received, such as anticoagulants, ACE inhibitors, beta blockers and lipid lowering agents. The study also confirms the synergistic effect of the modes of action of clopidogrel and aspirin.

In the CURE study, patients in the clopidogrel treatment arm received a 300mg loading dose of clopidogrel, followed by a once daily dose of 75mg clopidogrel for up to 12 months. All patients in both treatment arms received 75 to 325mg of aspirin daily.

Acute coronary syndrome (unstable angina and NQMI) is a classic example of atherothrombosis, the underlying process leading to heart attacks and strokes. Unstable angina is characterized by frequent and severe attacks of chest pain, sometimes lasting for more than 20 minutes, which can occur at rest, or during gentle exercise. Unstable angina and NQMI are major causes of morbidity and mortality i . The incidence of unstable angina is similar to that of heart attack, with close to 1.5 million episodes per year in North America and several times this figure in the world.

The CURE study was organized by an independent group of investigators and was coordinated by the Canadian Cardiovascular Collaboration, at McMaster University, Hamilton, Canada. The study was supported by a grant from Sanofi-Synthelabo and Bristol-Myers Squibb Company.

i Maynard SJ, Scott GO, Riddell JW, and Adgey AAJ. Regular review: Management of acute coronary syndromes. British Medical Journal; 2000:321:220-223 .





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