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| |  ISA: Lescol XL (Fluvastatin) Effectively Manages Major Lipid Parameters In Dyslipidemia EAST HANOVER, NJ -- June 28, 2000 -- Results from three pivotal Phase III studies presented at the 12th International Symposium on Atherosclerosis in Stockholm, Sweden demonstrated that treatment with the investigational extended release 80 mg tablet Lescol® XL (fluvastatin sodium) produced a 38 percent median decrease in low-density lipoprotein cholesterol (LDL-C) and up to an 18.7 percent mean increase in high-density lipoprotein cholesterol (HDL-C) in patients with dyslipidemia. A previous meta analysis of data from the National Health and Nutrition Examination Survey (NHANES III) has shown that a mean LDL-C reduction of 30 percent or less is sufficient to bring more than 90 percent of primary prevention patients to their treatment goals (as defined by The National Cholesterol Education Program). Almost 70 percent of coronary heart disease patients have low HDL-C. These patients carry an increased risk of cardiovascular events of almost 40 percent. Hence the increase of up to 18.7 percent in HDL-C yielded by Lescol XL 80 mg is clinically relevant. "The new extended-release formulation of fluvastatin has improved efficacy for LDL-C, HDL-C, and triglycerides. The pharmacological profile of this new version of fluvastatin results in effective management of all major lipid parameters, giving fluvastatin the potential to become an important new tool in the management of total atherogenic risk," says Professor Christie M Ballantyne, Clinical Director, Section Atherosclerosis, Baylor College of Medicine, Houston, Texas USA. The Phase III randomized, double-blind, Lescol XL 80 mg active-controlled studies involved 857 patients treated with Lescol XL in 12 countries in Europe, South Africa and North America and demonstrated that Lescol XL 80 mg reduced LDL-C by a median of 38 percent, triglycerides (TG) by a median of 19 percent and apolipoprotein B (Apo B) by a mean of 27 percent. In patients with primary mixed dyslipidemia (Frederickson Type IIb), Lescol XL 80 mg produced a median reduction of 25 percent in TG. Additionally, patients with elevated triglycerides experienced a mean increase in HDL-C of 18.7 percent. The data confirmed that Lescol XL 80 mg provides significantly improved efficacy with a similar safety profile when compared to Lescol (fluvastatin sodium) 40 mg. Adverse events were generally mild and similar to placebo. Common adverse events were fatigue, nausea, diarrhea, dyspepsia, abdominal pain and rash. In phase II and III trials with a total of 900 patients treated with Lescol XL 80 mg, there have been no cases of myopathy or rhabdomyolysis reported to date. Statins block the enzymatic pathway for cholesterol synthesis in the target treatment organ, the liver. The reformulated extended-release 80 mg Lescol XL tablet provides patients with a higher dose of medication, while maintaining safety. With this slow release delivery form of a statin, availability of the drug compound to the liver is increased while minimizing the risk of high systemic exposure. In addition, Lescol XL 80 mg is not metabolized by the cytochrome P450 3A4 pathway to any clinically significant extent, thus reducing the risks of interactions with common daily drugs that are metabolized through this pathway. The current formulation of fluvastatin sodium (sold as Lescol) is marketed in more than 90 countries worldwide as an adjunct to diet and exercise for the treatment of elevated total cholesterol, LDL-C, TG and Apo B in patients with primary hypercholesterolemia and mixed dyslipidemia and to slow the progression of atherosclerosis in patients with coronary heart disease. Lescol has been studied in more than 25,000 patients. Novartis Pharmaceuticals Corporation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the extended-release Lescol XL 80 mg tablet for an indication as an adjunct to diet to reduce elevated total cholesterol, LDL-C, TG and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Filings for Lescol XL 80 mg have also been submitted to European health authorities. In clinical trials with Lescol, adverse events 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. It is recommended that liver function tests be performed before the initiation of therapy and at 12 weeks following initiation of treatment or elevation in dose. If serum transaminase levels rise, monitor more often; if they persist at great than or equal to three times the upper limit of normal, discontinue Lescol. Treatment with Lescol should be discontinued if myopathy or rhabdomyolysis are diagnosed or suspected. Related Links: Lescol XL (fluvastatin sodium) and Novartis Pharmaceuticals Corporation.
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