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Less Frequent Liver Function Testing Recommended For Cholesterol Drug WEST POINT, Pa., June 2, 1997 -- The U.S. Food and Drug Administration (FDA) has cleared Merck & Co., Inc.’s new liver-function testing recommendations for patients taking the cholesterol-lowering drug Zocor (simvastatin). It is now recommended that liver function tests be performed with Zocor at the start of therapy and periodically (such as semi-annually) only for the first year of treatment or until one year after the last elevation in dose. Previously, liver function testing for patients on Zocor was recommended at the start of treatment, at six and twelve weeks, and semiannually for the duration of treatment. The revised recommendation is based on the long-term safety profile of Zocor demonstrated in the landmark Scandinavian Simvastatin Survival Study (4S). In this 5.4-year study of 4,444 men and women with high cholesterol and heart disease, treatment with Zocor reduced overall risk of death by 30 percent due to a 42 percent decreased risk of death from coronary heart disease. Further supporting these benefits of treatment is the finding that the long-term safety and tolerability of Zocor were comparable to placebo in this study. Zocor is indicated for use with diet to lower cholesterol in patients with primary hypercholesterolemia (Types IIa and IIb). In patients with coronary heart disease and high cholesterol, Zocor is indicated to reduce the risk of death by preventing heart attacks, reduce the risk of heart attacks and reduce the risk of heart-related surgical procedures (such as bypass surgery). Zocor should not be used in patients with active liver disease; unexplained persistently elevated liver enzymes; allergies to any component of the product; or in women who are nursing, pregnant or of childbearing age unless highly unlikely to conceive. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health. E-mail this page to a friend or colleague! To print, use this version