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Landmark Study: Pravastatin Reduces Risk of Heart Attack and Saves Lives ANAHEIM, Calif., Nov. 15, 1995 -- People with high cholesterol can rapidly reduce their risk of having a first-time heart attack by 31 percent and their risk of death by 22 percent, by taking a widely prescribed drug called pravastatin sodium. This is the conclusion of a landmark study presented here today at the annual meeting of the American Heart Association. The results appear in the November 16, 1995, edition of the New England Journal of Medicine. The West of Scotland Coronary Prevention Study (WOS) found that treatment with pravastatin reduced the risk of first-time heart attack and death, and the time-to-event curves began to diverge at six months after initiating therapy. The results of WOS make pravastatin the only drug in its class (HMG-CoA reductase inhibitor, or "statin") that has demonstrated the ability to rapidly reduce the risk of both death and first-time heart attack in people with high cholesterol. This is particularly important, because approximately one-fourth to one-third of individuals who have a first coronary event will die from it, according to statistics from the National Heart, Lung and Blood Institute. A four-study pooled-analysis recently published in the journal Circulation demonstrated that pravastatin significantly reduces the risk of heart attack by 62 percent in patients who have high cholesterol and established heart disease. West of Scotland extends the evidence to show that pravastatin provides early, sustained and significant reductions in cardiovascular disease and death in patients with elevated cholesterol but without previous heart attack. "We can say now with confidence that pravastatin reduces the risk of heart attack and death in a broad range of people -- not just those with established heart disease, as has been previously proven, but also among those who are at risk for their first heart attack," said principal investigator James Shepherd, M.D., Ph.D., professor, University Department of Pathological Biochemistry, Royal Infirmary, Glasgow, Scotland. The WOS study was a randomized, double-blind, placebo-controlled trial that included 6,595 men between the ages of 45 and 64 who had elevated LDL-cholesterol levels (range = 155-232 mg/dL, or 4.0-6.0 mmol/L). None of the participants had a previous heart attack. Mean follow-up was five years. The findings from WOS are as follows: Event Risk Reduction Statistical Significance Nonfatal heart attack or death from heart disease 31% p=0.0001 Heart attack 31% p=0.005 Revascularization procedures 37% p=0.009 Death from cardiovascular causes 32% p=0.033 Death from any cause 22% p=0.051* *When adjusted for baseline risk factors, risk reduction equals 24% (p=0.039). "These are some of the most striking data I have ever seen in heart attack and total mortality reduction," said Prof. Shepherd. "The findings strongly support current treatment guidelines and irrefutably encourage physicians to actively treat people who are at risk for heart attack,"he added. In the WOS study, nearly one-third of expected heart attacks are avoided in pravastatin-treated patients. Treatment and five-year follow-up for each heart attack sufferer costs an estimated $50,000 in the United States. By significantly decreasing the incidence of heart attack, therefore, it is anticipated that pravastatin therapy in this population will have a favorable impact on healthcare expenditures. A cost-effectiveness analysis based on the WOS study is currently being developed. A remaining unanswered question relates to the treatment of people with heart disease and "normal" cholesterol levels. The Cholesterol and Recurrent Events (CARE) trial is currently looking at the impact of pravastatin on the occurrence of heart attack or death from heart disease in more than 4,000 men and women with normal cholesterol levels who have already suffered a heart attack. CARE is scheduled for completion in February 1996. Pravastatin is generally well tolerated. The most common side effects include mild and transient skin rash and gastrointestinal upset, and are similar to those seen with placebo. The WOS study was conducted by the University of Glasgow, Scotland, and funded by a grant from Bristol-Myers Squibb. It was conducted in and around the city of Glasgow, where the local population utilizes a highly centralized primary-care service and few people move in and out of the community, making it feasible to monitor participants over time. E-mail this page to a friend or colleague! To print, use this version