PRINCETON, N.J., April 1 /PRNewswire/ -- Results from the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, demonstrating the benefits of Pravachol(R) (pravastatin sodium) in reducing the risk of stroke among people with a history of heart disease were presented at the 47th Annual Scientific Sessions of the American College of Cardiology in Atlanta, Georgia. The presentation of the LIPID results offers an additional demonstration of the benefits of Pravachol in reducing the risk of a stroke in this patient population. The presentation of the LIPID results follows last week's clearance by the U.S. Food and Drug Administration of Pravachol for an important new indication: for use in reducing the risk of a stroke or a transient ischemic attack (TIA), otherwise known as a "miniature" stroke, in patients who have had a heart attack and have normal cholesterol levels (less than 240 mg/dl total cholesterol) and to reduce the risk of a recurrent heart attack and death from heart disease in this patient population. These patients represent the majority of people who had a heart attack. The new indication is based on the results of another landmark study, the Cholesterol and Recurrent Events (CARE) trial. The indication is even more compelling because the majority of patients in the CARE trial were already taking aspirin, which is known to have a beneficial impact on the reduction of stroke. "In population studies, there appears to be a weak relationship between cholesterol levels and risk of non-hemorrhagic stroke, which is the major cause of stroke," said Dr. Andrew Tonkin, Principal Investigator of LIPID and Director of Health, Medical and Scientific Affairs with the National Heart Foundation of Australia. "We know that the risk of stroke in LIPID and CARE was significantly reduced in patients with what would be considered to be relatively normal cholesterol levels. The mechanisms underlying this risk reduction are not exactly clear. However, what we do know is that pravastatin works to reduce stroke." Pravachol, which is a member of the HMG-CoA reductase inhibitor class of drugs, is the first drug of its kind to receive FDA clearance for the indication to reduce the risk of a stroke or a TIA in patients who have had a heart attack and have normal cholesterol levels. In addition, Pravachol is the first and only drug of its kind to receive FDA clearance for use in reducing the risk of a recurrent heart attack and death from heart disease in patients with normal cholesterol levels. "Pravachol appears to be especially effective in its ability to decrease stroke risk," said Eric Raps, M.D., Director of Comprehensive Stroke Center, University of Pennsylvania Medical Center. "It is important to note that the relationship between cholesterol and the risk of stroke is weak and the evidence suggests that Pravachol reduces the risk of stroke through mechanisms beyond its effect on cholesterol." More than 4 million people worldwide are believed to suffer a stroke each year. Stroke is the third-leading cause of death and the leading cause of disability. Approximately two-thirds of the people who suffer a stroke will experience severe disabilities including paralysis, loss of speech and lapses of memory. In the United States, the cost of care and rehabilitation of stroke exceeds $30 billion per year. The LIPID study was a five-year, double-blind placebo-controlled study of 9,014 male and female patients who had either suffered a heart attack or had a history of unstable angina and had normal or slightly elevated cholesterol levels. The LIPID study was conducted by an independent group of researchers under the auspices of the Heart Foundation of Australia and coordinated by the National Health and Medical Research Council's Clinical Trials Centre at the University of Sydney. The CARE study was a five-year, double-blind placebo-controlled study that enrolled 4,159 men and women who had suffered a heart attack in the two years prior to enrollment. Patients in CARE had an average total cholesterol level of 209 mg/dl, a level that is similar to that of the U.S. population and Canada. In the CARE study patients who received Pravachol reduced their risk of a stroke or TIA by 26 percent, and reduced their risk of recurrent heart attack and death from heart disease by 24 percent. Pravachol therapy is well tolerated by most patients. The most common side effects include mild skin irritation and transient rash and gastrointestinal upset. Pravachol should not be used by people with active liver disease or liver problems, in women who are pregnant or nursing or people who are allergic to any component of the medication. Muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor. Bristol-Myers Squibb licensed Pravachol 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 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. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com For full Pravachol(R) (pravastatin sodium) prescribing information, call Bonnie Jacobs of Bristol-Myers Squibb at 609-252-4213.
SOURCE Bristol-Myers Squibb