The efficacy and safety of lipid-lowering agents in elderly individuals have not been extensively assessed. This population generally takes more drugs concurrently than middle-aged patients, and are therefore at higher risk of drug-drug interactions. This large-scale, randomized, double-blind, placebo-controlled study investigated the efficacy and safety of extended-release (XL) fluvastatin 80 mg once daily for up to 1 year in elderly patients with primary hypercholesterolemia. A total of 1229 patients (mean age, 75.5 years) were randomized. After 2 months of treatment, fluvastatin XL 80 mg significantly decreased plasma lipid levels from baseline compared with placebo; fluvastatin reduced total cholesterol by 25% compared with a decrease of 2.5% in the placebo group, low-density lipoprotein cholesterol was -33% vs. -2.5%, respectively, and triglycerides were -13.3% vs. 2.9%, respectively (p<0.00001). The safety profile of fluvastatin XL was similar to that of placebo. Fluvastatin XL 80 mg once daily was well tolerated and effectively managed plasma lipid profiles in a large cohort of elderly patients. These findings are consistent with data obtained previously in younger recipients of fluvastatin XL 80 mg, and reinforce the safety of fluvastatin in a population at high risk of drug-drug interactions.
Copyright 2003 Le Jacq Communications, Inc.