To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves New Dosage Range For Cholesterol-Lowering Drug Zocor URL: http://www.pslgroup.com/dg/8E0B6.htm Doctor's Guide July 13, 1998
WEST POINT, PA -- July 13, 1998 -- The United States Food and Drug Administration has approved a new 80-mg tablet of Merck & Co., Inc.'s Zocor(R) (simvastatin), which lowered LDL cholesterol in clinical studies by a mean of 47 percent. In addition, the official prescribing information for Zocor has been changed to recommend the existing 20 mg tablet of Zocor as the usual starting dose for this cholesterol-lowering medicine. Patients who require only a moderate reduction of LDL cholesterol may still be started at 10 mg. "This new recommended dosage range offers physicians a potent lipid-lowering regimen to meet the needs of their patients, backed by proof from the landmark Scandinavian Simvastatin Survival Study, that this drug saves lives and prevents heart attacks and strokes in people with heart disease and high cholesterol," said D. Roger Illingworth, M.D., professor of medicine and director, Lipid Disorders Clinic, Oregon Health Sciences University. In addition to lowering LDL cholesterol by a mean of 47 percent, Zocor 80 mg (in 189 patients with triglycerides over 200 mg/dL) lowered triglycerides by a median 36 percent. These results are based on a 24-week trial comparing the efficacy and safety of Zocor 40 mg in 433 patients and Zocor 80 mg in 664 patients. Zocor 80 mg was well-tolerated, with only 1.5 percent of the patients on the 80 mg strength discontinuing treatment due to drug-related side effects, compared to 1.4 percent of the patients on Zocor 40 mg. In this study the incidence of myopathy (muscle pain or weakness indicating a rare but potentially severe side effect of Zocor) was 0.7 percent for the 80 mg dosage and 0.2 percent for the 40 mg dosage. The incidence of liver enzyme elevations, which are a sign of liver damage, was 2.1 percent for the 80 mg dosage and 0.9 percent for the 40 mg dosage in this trial. "These data reaffirm the ability of Zocor to dramatically lower cholesterol with favourable tolerability even at the highest doses," Dr. Illingworth said. Zocor was the first cholesterol-lowering medicine proven to save lives and prevent heart attacks in patients with high cholesterol and heart disease. In the five-year, 4,444-patient Scandinavian Simvastatin Survival Study, Zocor demonstrated a 42 percent reduction in death from heart disease, a 34 percent reduction in heart attacks and a 28 percent reduction in stroke or ministroke in patients with high cholesterol and heart disease. The 20 mg tablet was the starting dose in 4S; patients were allowed to be titrated as needed to the 40 mg dose of Zocor. The FDA has also approved Zocor as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (FH), a very rare but serious condition affecting approximately one out of every million persons. Homozygous FH is an inherited condition marked by abnormally high levels of cholesterol in the blood and can cause coronary heart disease to develop at a very young age. The recommended dosage for patients with homozygous FH is Zocor 40 mg once per day, or 80 mg per day in three divided doses of 20 mg, 20 mg and an evening dose of 40 mg. "The efficacy and safety profile of Zocor in these high-risk patients gives physicians an important new tool to battle the consequences of inherited high cholesterol," Dr. Illingworth said. "FH historically has been very difficult to treat effectively, and the results for many patients have been tragic." Zocor should be used in addition to diet to lower elevated cholesterol levels after diet alone has failed to achieve target levels. In patients who have been hospitalised 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. Zocor should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. Muscle pain or weakness in patients taking Zocor should be reported to a doctor, because these could be signs of a serious side effect. Doctors may perform blood tests to check liver function before and during treatment with Zocor. Patients taking the 80 mg dose of Zocor should receive an additional liver function test at three months. While 20 mg is recognised as the new recommended usual starting dose for Zocor, the 5 mg and 10 mg dosage strengths will remain available. More information on: Zocor, Merck & Co., Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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