Short-term efficacy and safety of extended-release fluvastatin in a large cohort of elderly patients

Am J Geriatr Cardiol. 2003 Jul-Aug;12(4):225-31. doi: 10.1111/j.1076-7460.2003.02000.x.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticholesteremic Agents / adverse effects
  • Anticholesteremic Agents / therapeutic use*
  • Cholesterol / blood
  • Double-Blind Method
  • Fatty Acids, Monounsaturated / adverse effects
  • Fatty Acids, Monounsaturated / therapeutic use*
  • Female
  • Fluvastatin
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / drug therapy*
  • Indoles / adverse effects
  • Indoles / therapeutic use*
  • Male
  • Prospective Studies
  • Treatment Outcome
  • Triglycerides / blood

Substances

  • Anticholesteremic Agents
  • Fatty Acids, Monounsaturated
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Indoles
  • Triglycerides
  • Fluvastatin
  • Cholesterol