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| |  FDA Approves Zocor To Lower Both Cholesterol and Triglycerides WEST POINT, PA -- November 6, 1997 -- The U.S. Food and Drug Administration (FDA) has officially cleared Zocor(R) (simvastatin), Merck & Co. Inc.’s cholesterol-lowering drug, to lower triglyceride levels in addition to its established role of lowering total and LDL cholesterol in patients with both high cholesterol and high triglycerides. Triglycerides are blood fats that may be elevated in people with high cholesterol and heart disease. In patients with high cholesterol alone or with high cholesterol and triglycerides, Zocor is now indicated as an adjunct to diet to reduce triglycerides, as well as total and LDL cholesterol levels. The impact of Zocor on triglycerides has been included in the Clinical Pharmacology section of the prescribing information for Zocor since it first received U.S. marketing clearance in 1991. The current action makes it a recognized use of the drug. In an analysis of five separate studies (of up to 18 weeks duration) involving 359 patients with high cholesterol, the patients with greater baseline triglycerides achieved the greatest triglyceride reductions. Zocor reduced triglycerides by a median 31 percent in patients with baseline triglyceride levels greater than 200 mg/dL. In patients with baseline triglyceride levels between 150 and 200 mg/dL, Zocor reduced triglycerides by a median 21 percent and, in patients with baseline triglycerides under 150 mg/dL, Zocor reduced triglycerides by a median 11 percent. Corresponding mean triglyceride reductions for each subgroup were 25 percent, 18 percent and five percent, respectively. In earlier clinical studies of patients without high triglycerides but with high cholesterol, therapy with Zocor resulted in a mean 10 percent to 19 percent reduction from baseline after eight weeks. Both the NCEP and the American Heart Association (AHA) have classified fasting triglyceride levels below 200 mg/dL as normal, those from 200 mg/dL to 399 mg/dL as borderline high, and those 400 mg/dL or above as high. Elevated plasma triglycerides have not been established as an independent risk factor for CHD. The independent effect of lowering triglycerides on CHD and death has also not been determined. Based on the results of the landmark Simvastatin Survival Study, Zocor is the only member of the class of medicines known as statins proven to save lives and prevent heart attacks in patients with high cholesterol and coronary heart disease (CHD). In that 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 CHD. Zocor should be used in addition to diet to lower elevated cholesterol and triglyceride levels after diet alone has failed to achieve target levels. In patients who have been hospitalized with an acute coronary event such as a heart attack or worsening chest pain, consideration can be given to initiating drug therapy at the time of discharge if LDL cholesterol levels are at 130 mg/dL or higher. Patients experiencing unexplained muscle pain or weakness while taking Zocor are advised to notify their doctor immediately. Zocor should not be used by anyone who is allergic to any of its components, patients with liver disease or elevated liver enzymes, or women who are pregnant, breast-feeding, or of childbearing age who could become pregnant. Liver function tests should be performed at the start of therapy with Zocor and periodically (such as semi-annually) for the first year of treatment or until one year after the last elevation in dose. More information on: Zocor, Merck & Co. Inc.
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