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| |  FDA Approves New Lescol Indication To Reduce Triglycerides And Apo B EAST HANOVER, NJ -- March 9, 1999 -- The United States Food and Drug Administration has approved a new indication for Novartis Pharmaceutical Corp.’s cholesterol-lowering medication Lescol(R) (fluvastatin sodium) to additionally decrease triglycerides (TG) and apolipoprotein B (Apo B) in patients with mixed dyslipidemia (both elevated cholesterol and triglycerides). In the U.S., approximately 40 percent of patients with abnormal blood lipids have elevations in both their cholesterol and triglycerides. The new indication is based on the results of a pooled analysis of 12 Lescol placebo-controlled trials in over 1,600 patients with hypercholesterolemia and mixed dyslipidemia. According to the all patient analysis, patients treated with Lescol demonstrated significant reductions in TG, Apo B, LDL-C, total cholesterol and variable increases in HDL-C. Analysis of patients with baseline TG greater than or equal to 200 mg/dL demonstrated that Lescol 40 mg and 80 mg (40 mg b.i.d.) reduced TG by 19.6 percent and 23.2 percent, respectively; and reduced Apo B by 18.3 percent and 28.1 percent, respectively. In addition to the new indication, safety data from a pooled analysis has led the FDA to recommend fewer liver function tests (LFT) for patients taking Lescol. While LFT monitoring is required of all drugs in the class of cholesterol-lowering HMG-CoA reductase inhibitors or statins, the frequency of that testing varies from drug to drug. With respect to the class of drugs, Lescol now requires a minimal amount of LFT monitoring. According to the revised Lescol labelling, LFT monitoring is recommended before initiation of therapy and at 12 weeks following initiation of treatment or elevation in dose. If LFT monitoring results are normal, no further testing is required. It is still recommended that any LFT abnormality be closely monitored. Previous labelling required liver function tests be performed before the initiation of treatment, at six and 12 weeks after initiation of therapy or elevation in dose, and periodically (for example, semi-annually). Lescol is now 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. There are more than 100 recently completed or ongoing clinical trials world-wide with Lescol among various populations, including patients with diabetes, hypertension, coronary heart disease and kidney disease. Lescol is also being evaluated in two separate prevention trials involving renal transplant patients and those with coronary heart disease. In clinical trials, adverse events to Lescol were generally mild and similar to placebo. Common adverse events were fatigue, nausea, diarrhea, dyspepsia, abdominal pain and rash. Lescol should not be used by pregnant or nursing women, in patients who currently have liver disease or unexplained increases in liver enzyme levels, and in patients who are allergic to any ingredient in this medication. Treatment with Lescol should be discontinued if myopathy and rhabdomyolysis are diagnosed or suspected. Persistent LFT elevations (greater than three times the upper limit of normal) occurred at an incidence of 0.2 percent, 1.5 percent and 2.7 percent for 20, 40 and 80 mg (40 mg b.i.d.), respectively. Related Links: Lescol, Novartis Pharmaceutical Corp.
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