If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Pravachol Reduces Risk of Recurrent Heart Attack and Death PRINCETON, N.J., Oct. 2, 1996 -- Results of a five-year study with Bristol-Myers Squibb's (NYSE: BMY) cholesterol-lowering drug, Pravachol (pravastatin sodium), demonstrate that patients who have had a heart attack, but have average cholesterol levels, can reduce their risk of heart attack and death from coronary heart disease by taking the drug. The study also demonstrated a reduction in the frequency of stroke. Pravachol also reduced the incidence of revascularization procedures such as bypass surgery and balloon angioplasty. Pravachol is the only HMG CoA reductase inhibitor shown to have these benefits in patients with average cholesterol levels. The results of the Cholesterol and Recurrent Events (CARE) study, the only trial to evaluate the benefits of lowering cholesterol in patients with average cholesterol levels who have survived a heart attack, were published in the October 3, 1996, issue of The New England Journal of Medicine. The CARE trial was a five-year, double blind study led by researchers from Brigham and Women's Hospital and the Harvard Medical School in Boston. CARE enrolled 4,159 men and women aged 21 to 75 years of age who had suffered a heart attack in the two years before enrollment. The participants, monitored at 80 centers in the United States and Canada, were randomly assigned to receive Pravachol or placebo. The primary endpoint was a fatal coronary event or a nonfatal myocardial infarction. Patients studied in CARE had an average total cholesterol level of 209 mg/dl, a level similar to that of the average U.S. population. In CARE, Pravachol significantly reduced the risk of having another heart attack or dying from heart disease by 24 percent, and reduced the need for bypass surgery by 26 percent and coronary angioplasty by 23 percent. Additionally, Pravachol reduce the incidence of stroke by 31 percent. In demonstrating the benefit of Pravachol in the reduction of stroke risk, the study is the first to report such a benefit as a specified endpoint for any lipid-lowering agent. The CARE results are particularly striking because they were demonstrated in patients who were already benefiting from other post-heart attack treatments such as aspirin, beta-blockers, bypass surgery or balloon angioplasty. What is noteworthy about the results in the CARE trial is that they were achieved in patients who are typical of those encountered in clinical practice in both North America and Europe. Patients with cholesterol levels in the same range as those of the CARE population represent 75 percent of heart disease patients in the U.S., and more than 60 percent of heart disease patients in Europe. Coronary heart disease is the most common cause of death in the western world and has a major economic impact on many countries' healthcare systems. The CARE study demonstrated that over a five year period, for every 1,000 patients treated with pravastatin, 150 cardiovascular events, such as heart attacks, were avoided. A cost-effectiveness analysis on CARE will be reported at a later date. As reported in an earlier landmark study, the Pravachol Primary Prevention Study published in the November 1995 in The New England Journal of Medicine, Pravachol is the only HMG CoA cholesterol-lowering drug proven to reduce the risk of first heart attack and death from cardiovascular disease in patients with elevated cholesterol, but no history of heart disease. Pravachol is also the only drug of its kind indicated to both reduce the risk of heart attack and slow the progression of coronary atherosclerosis in patients with elevated cholesterol and heart disease. Therapy with Pravachol is well tolerated. However, the drug should not be used by people with active liver disease or liver problems, in women who are pregnant or breast feeding, or people who are allergic to any component of the medication. The most common side effects include mild skin irritation, transient rash and gastrointestinal upset. Bristol-Myers Squibb licensed pravastatin from its discoverer, Sankyo Company, Inc., of Japan and supported the CARE study with a grant from its Pharmaceutical Research Institute to the investigators. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products.
|
