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| |  Pravachol Cleared to Help Prevent First Heart Attack and Reduce Death PRINCETON, N.J., July 8, 1996 -- For the first time, the Food and Drug Administration (FDA) has cleared a cholesterol-lowering medication, Pravachol(R) (pravastatin sodium), to help prevent a first heart attack and reduce death from cardiovascular disease in patients with elevated cholesterol who are at risk of a first heart attack. Pravachol's new indication also includes reducing the need for balloon angioplasty or coronary bypass surgery. Pravachol is the only cholesterol-lowering drug of its kind proven to help prevent first heart attack in this predominant patient group who are at risk of a first heart attack despite the absence of symptoms. The new Pravachol indication is based on the Pravachol Primary Prevention Study (also known as the West of Scotland study), a landmark clinical trial demonstrating a significant reduction in the risk of a first heart attack in patients with elevated cholesterol, but no history of heart disease. The results of this study are particularly compelling because 800,000 of the 1.25 million heart attacks that occur each year in the U.S. are first heart attacks. Up to one third of first heart attacks will be fatal. Prevention of a first heart attack is known as "primary prevention." Approximately 17 million Americans with high cholesterol, but with no evidence of heart disease, are considered at risk for a first heart attack. As cardiovascular disease remains the leading cause of illness and death in the United States, the Pravachol "primary prevention" indication offers new hope for patients at risk. "The FDA clearance of Pravachol for `primary prevention' confirms that patients that fall into this category should be treated with Pravachol to help prevent an often deadly first heart attack from occurring. Diet and exercise are often not enough to reduce the risk of heart attack in these patients; therefore, the new indication should be a strong motivator to physicians who treat the millions of people who have elevated cholesterol and are at risk of a first heart attack," said James Shepherd, MD, Ph.D., professor, University Department of Pathological Biochemistry, Royal Infirmary, Glasgow, Scotland, and principal investigator of the West of Scotland Study. The Pravachol Primary Prevention Study, which evaluated the use of Pravachol in 6,595 patients over a five-year period, was reported at the American Heart Association annual meeting and published in The New England Journal of Medicine. The study demonstrated that Pravachol reduced the risk of first heart attack by 31 percent. Death from 2 cardiovascular disease was reduced by 32 percent, and importantly, there was no increase in death from non-cardiovascular causes. In addition, the study showed that Pravachol reduced the need for coronary procedures such as balloon angioplasty and bypass surgery by 37 percent. Scott M. Grundy, MD, member of the Coordinating Committee of the National Cholesterol Education Program and Chairman of the Adult Treatment Panel has said of the West of Scotland study, "Primary prevention -- preventing the development of coronary heart disease -- is a very large and important challenge. Addressing this challenge will reduce the burden of coronary heart disease on society. The results of the West of Scotland study indicate that reducing cholesterol levels with pravastatin reduces the risk of heart attacks in high risk patients in the primary prevention setting. Persons who believe they fall into this category should speak to their doctor." Another major finding from the Pravachol Primary Prevention Study was that Pravachol benefit, in terms of reduction in first heart attacks, begins at about six months after the initiation of therapy. "It is often difficult for patients with high cholesterol to remain compliant with their medication regimen because they do not feel sick. The early benefit seen with Pravachol should motivate patients to keep taking their therapy as prescribed, visit their doctors regularly, and eat healthfully and exercise," added Dr. Shepherd. In addition to being the only cholesterol-lowering drug of its kind proven to help prevent first heart attack and to reduce the risk of death from cardiovascular disease, Pravachol is the only HMG CoA reductase inhibitor indicated to both reduce the risk of heart attack and slow the build-up of plaque in the coronary arteries of patients with elevated cholesterol who have established symptoms of heart disease. Prevention of recurrent heart attack in patients with established heart disease is known as "secondary prevention." It is estimated that there are more than 4 million Americans who have elevated cholesterol levels and heart disease. Pravachol therapy is well tolerated by most patients. 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 and transient rash and gastrointestinal upset. Bristol-Myers Squibb licensed pravastatin from its discoverer, Sankyo Company, Inc., of Japan. 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 dermatologic 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.
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