The FDA has approved a new indication for Lescol (fluvastatin sodium) to additionally decrease triglycerides and apolipoprotein B (Apo B) in patients with mixed dyslipidemia. In the United States, approximately 40 percent of patients with abnormal blood lipids have elevations in both cholesterol and triglycerides. The new indication is based on the results of a pooled analysis of 12 Lescol placebo-controlled trials in more than 1,600 patients with hypercholesterolemia and mixed dyslipidemia. Lescol is currently indicated as an adjunct to diet and exercise for the treatment of elevated cholesterol, TG and Apo B in patients with hyperlipidemia and to slow the progression of atherosclerosis in patients with CHD. In addition to the new indication, additional safety data has led the FDA to recommend fewer liver function tests for patients taking Lescol. While liver function monitoring is required for all patients taking statins, the frequency varies from drug to drug; Lescol now requires a minimal amount of LFT m onitoring-before initiation of therapy and at 12 weeks following initiation of treatment.
COPYRIGHT 1999 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
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