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| |  EAS MEETING: Lescol ER Effective For Primary Hypercholesterolemia EAST HANOVER, NJ -- May 28, 1999 -- The first presentation from phase II studies of the investigational extended release formulation of Novartis Pharmaceutical Corp.’s Lescol 80 mg tablets demonstrate efficacy and tolerability in patients with primary hypercholesterolemia. These data show low-density lipoprotein cholesterol (LDL-C) mean reductions of 37 percent. In addition, reductions of up to 53 percent have been reported in these phase II trials. The pooled analysis also reports triglyceride (TG) mean reductions of 16 percent. The results are being presented at the 71st annual European Atherosclerosis Society congress in Athens, Greece. "These data demonstrate that the new formulation of fluvastatin is effective in treating a wide range of lipid abnormalities," said study author Michel Farnier, MD, Point Medical, Dijon, France. "The lipid reductions seen in the phase II study, along with the excellent safety profile support the continued investigation of this new agent." Two phase II, observer-blind-to-lipids variables, parallel-group trials were performed to evaluate the efficacy, safety and tolerability of the investigational extended release formulation of Lescol 80 mg tablets. Patients (mean age of 53 years) with primary hypercholesterolemia (type IIa/IIb) with LDL-C greater than 160 mg/dl and TG less than 350 mg/dl were randomised to receive the investigational extended-release formulation of Lescol 80 mg tablets once-daily at bedtime or the currently marketed formulation of Lescol The pooled results showed that the investigational extended release formulation of Lescol 80 mg tablets once daily produced mean reductions in LDL-C (-37 plus or minus 11) and TG (-16 plus or minus 22) and an increase in high-density lipoprotein cholesterol (HDL-C) (+3 plus or minus 10). In addition, the analysis of the phase II data show no notable liver abnormalities in the treatment group and that the investigational extended release formulation of Lescol 80 mg tablets are well-tolerated as a starting dose. According to the data, the number of suspected drug-related adverse events were similar in both treatment groups. The investigational extended release formulation of Lescol 80 mg tablets were developed to maximise first-pass hepatic extraction and reduce systemic exposure of higher doses. Similar to the current formulation of Lescol, the investigational extended release formulation of Lescol 80 mg tablets are not metabolised by the cytochrome P450 3A4 pathway to any meaningful extent, thus reducing the potential of serious drug interactions. There is an active clinical development program for the extended release formulation of Lescol 80 mg dose now under way, which includes a large-scale, primary prevention trial in 5,400 men and women aged 70 to 85 years with primary hypercholesterolemia. The Fluvastatin Assessment of Morbi-Mortality in the Elderly (FAME) has been initiated by Novartis Pharma AG to determine the effect of cholesterol-lowering treatment with extended release Lescol on the primary prevention of heart attack and stroke in elderly patients. Novartis plans to file applications for the approval of an extended release formulation of Lescol 80 mg tablets with regulatory agencies in U.S., Europe and elsewhere over the next six months. Related Links: Lescol, Novartis Pharmaceuticals Corp.
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