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| |  FDA Clears Zocor To Reduce Risk of First Stroke Or Transient Ischemic Attack WEST POINT, PA -- April 1, 1998 -- The United States Food and Drug Administration has approved Merck & Co., Inc.’s cholesterol-lowering drug Zocor(R) (simvastatin) to reduce the risk of first stroke or transient ischemic attack (TIA or mini-stroke) in people with high cholesterol and coronary heart disease -- those who are at the highest risk for cardiovascular events. This important new use of Zocor is based on an analysis of the landmark Simvastatin Survival Study (4S) which showed that people taking Zocor had significantly fewer strokes and TIAs compared to the group taking placebo. "In 4S, Zocor reduced the risk of stroke and TIA by 28 percent, said Terje Pedersen, M.D., 4S lead investigator and head physician, Coronary Care Unit, Aker University Hospital in Oslo, Norway. "We have known for some time that controlling high blood pressure is essential to reducing the risk of stroke. Now we know that treatment with Zocor provides a powerful new weapon in battling debilitating strokes." The finding that lowering cholesterol can prevent stroke, along with other advances, has prompted the National Stroke Association (NSA) to issue new Stroke Prevention Guidelines in conjunction with a panel of leading national experts. The NSA recommends that all people know their cholesterol levels and treat high cholesterol with diet, exercise and medication to reduce risk of stroke. In addition to high cholesterol, other risk factors for stroke include high blood pressure, heart disease, smoking and obesity. According to the NSA, stroke is the third leading cause of death in the U.S., killing 157,991 people in 1995 (the last year for which figures were available) and accounting for one of every 15 deaths. In the U.S., someone has a stroke every minute -- every 3.4 minutes someone dies of stroke. For those who survive, stroke is one of the leading causes of adult disability, affecting about four million Americans, as well as their families and caregivers. The landmark Framingham Heart Study found that after suffering a stroke, 31 percent of patients require assistance, 20 percent need help walking and 71 percent are vocationally impaired after seven years. In economic terms, stroke-related expenses annually cost $30 billion to the U.S. health care system. The stroke-reduction data are the latest in a series of important clinical benefits derived from 4S, the first study to define the life-saving benefits of lowering cholesterol with Zocor. In the five-year trial, involving 4,444 men and women with high cholesterol and coronary heart disease -- those at highest risk for cardiovascular events -- the group treated with Zocor (20 or 40 mg once daily) had: -- 28 percent fewer fatal or non-fatal strokes and TIAs In 4S, Zocor was well-tolerated. Zocor should not be used by anyone on concomitant therapy with the tetralol-class calcium-channel blocker mibefradil, allergic to any of its components, with liver disease, or by women who are pregnant, nursing or likely to become pregnant. Muscle pain or weakness in patients taking Zocor may indicate a rare but serious side effect and should be reported to their doctor. Doctors should perform blood tests to check liver function before and periodically during treatment with Zocor. Despite the landmark findings of 4S and guidelines from the American Heart Association (AHA), National Cholesterol Education Program (NCEP) and NSA calling for aggressive treatment, about 60 percent of people who have already had a heart attack are not taking the appropriate steps to control their cholesterol. In addition, another 16 million Americans without heart disease who could benefit from lowering their high cholesterol to recommended levels are still going untreated. More information on: Zocor and Merck & Co., Inc..
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