AHA SCIENTIFIC SESSIONS: Norvasc Demonstrates 31% Reduction In Cardiovascular Events
DALLAS, TX -- Dec. 8, 1998 -- Patients with coronary artery disease taking
Pfizer's calcium channel blocker, Norvasc (amlodipine besylate), had 31 percent
fewer cardiovascular events than patients treated with placebo, according to
results from the 825-patient Prospective Randomized Evaluation of the Vascular
Effects of Norvasc Trial (PREVENT).
Cardiovascular morbidity and mortality events include heart attacks, strokes,
deaths, angioplasty, bypass surgery, hospitalisations for severe angina and heart
failure. The reduction for angioplasty and bypass surgery was 46 percent and the
patients treated with Norvasc also had 35 percent fewer hospitalisations for
severe chest pain.
"This is an unexpected, highly favourable result that is in keeping with our
favourable experience with this drug," said John Mancini, M. D., professor and
head of the department of medicine at the University of British Columbia and the
Vancouver Hospital and Health Sciences Centre who directed the primary
analyses for the PREVENT trial. "The major importance of PREVENT is that
the drug amlodipine showed dramatic effect for reducing hospitalisations for
angina, angioplasty and bypass surgery in patients with coronary disease."
The PREVENT trial, which was presented today at the American Heart
Association meeting November 11th, enrolled patients who had coronary artery
disease at the start of the trial and were treated with standard medications for
their cardiovascular conditions as necessary. In addition, half the patients
received Norvasc, a long-acting calcium channel blocker characterised by a
gradual onset of action and a long half-life.
In PREVENT, angiographic analysis of coronary arteries in Norvasc patients,
the primary endpoint of the study, showed no discernible difference in the
progression of atherosclerosis compared to placebo patients. However,
researchers observed a significant reduction in plaque build-up in the carotid (the
major artery found in the neck that supplies the brain) in Norvasc patients
compared with placebo. This evaluation used imaging technology known as
ultrasound while the coronary artery measurement was based on angiography.
Researchers believe that ultrasound technology is much more sensitive in
measuring plaque progression or reduction.
High blood pressure, diabetes and high cholesterol are risk factors associated
with the development of atherosclerosis that affects the coronary and carotid
arteries. Cardiovascular disease claims the lives of approximately 79,000
Canadians annually and is the leading cause of death in Canada.
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