Pfizer Ccb Norvasc Demonstrates 31 Percent Reduction In Cardiovascular Events, New Study Shows November 12, 1998 11:03 AM
MONTREAL, Nov. 12 /CNW/ - Patients with coronary artery disease taking the Pfizer 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, hospitalizations 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 hospitalizations 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 hospitalizations for angina, angioplasty and bypass surgery in patients with coronary disease.''
''A reduction in the rate of onset of angina and coronary revascularization was observed with amlodipine in all subgroups, including patients taking and not taking beta-blockers. Furthermore, the PREVENT study shows that compliance is excellent with amlodipine (81%) over three years,'' stated Dr. Normand Racine, head of the CHUM cardiology unit.
The PREVENT trial, which was presented yesterday at the American Heart Association meeting, 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 characterized 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 discernable 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. The next sentence is new.Cardiovascular disease claims the lives of approximately 79,000 Canadians annually and is the leading cause of death in Canada.
''PREVENT is the latest in a series of major clinical trials supporting the value of Norvasc, an innovative medicine that has had more than 8 billion patient days of therapy worldwide since its introduction,'' said Bernard Prigent, M.D., senior associate medical at Pfizer Canada Inc. ''PREVENT gives us important information about Norvasc and coronary artery disease.''
Norvasc, the world's most prescribed branded agent for hypertension and angina, has been studied in more that 190 clinical trials worldwideNorvasc is also being studied in the ongoing 43,000-patient National Institutes of Health ALLHAT trial, which is the largest study ever undertaken in hypertension.
Pfizer is a global health care company dedicated to research and development of medicine to treat unmet medical needs. It had sales of about US $125 billion for 1997 and this year expects to invest about US $2.3 billion in research and development. Global headquarters are in New York city where the company was founded in 1849. Pfizer Canada Inc. employs more than 1,000 persons across Canada and is headquartered in Kirkland, Quebec.
For further information: For interview: Johanne Denault, GPC Concordia, Montreal, (514) 288-1808, Michele Carroll, GPC Communications, Toronto, (416) 598-0055, Lori Pike, GPC Communications, Vancouver, (604) 688-2505 or Don Sancton, Associate Director, Corporate Affairs, Pfizer Inc., (514) 426-7063 10:49 ET
CNW 10:48E 12-NOV-98 |