Efficacy and safety of fluvastatin-extended release in hypercholesterolemic patients: morning administration is equivalent to evening administration

Cardiology. 2006;106(4):241-8. doi: 10.1159/000093200. Epub 2006 May 10.

Abstract

Background: Flexibility in the time of administration of statin therapy is likely to improve patient compliance. This study compared the efficacy and tolerability of morning and evening administration of the extended-release formulation of fluvastatin (fluvastatin XL).

Methods: In this prospective, double-blind, multicenter, multiple dose study, 236 patients with type IIa/b hypercholesterolemia were randomized to receive fluvastatin XL, 80 mg, in the morning or evening for 8 weeks.

Results: At 8 weeks, low-density lipoprotein cholesterol levels were reduced by 34.5 and 35.0% in the morning and evening treatment groups, respectively (p = 0.0118 for non-inferiority of morning administration). There were no statistically significant differences between the morning and evening treatment groups in the changes in total cholesterol (p = 0.56), high-density lipoprotein cholesterol (p = 0.21), triglycerides (p = 0.13), apolipoprotein B (p = 0.66) and apolipoprotein AI (p = 0.88) at 8 weeks. The frequency of adverse events was slightly lower in the morning treatment group compared with the evening treatment group (27.4 vs. 35.5%).

Conclusions: The efficacy and safety profiles of fluvastatin XL are equivalent for morning and evening administration.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anticholesteremic Agents / administration & dosage*
  • Anticholesteremic Agents / adverse effects
  • Apolipoproteins B / blood
  • C-Reactive Protein / metabolism
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Circadian Rhythm
  • Delayed-Action Preparations
  • Fatty Acids, Monounsaturated / administration & dosage*
  • Fatty Acids, Monounsaturated / adverse effects
  • Female
  • Fluvastatin
  • Homocysteine / blood
  • Humans
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / drug therapy*
  • Indoles / administration & dosage*
  • Indoles / adverse effects
  • Male
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome

Substances

  • Anticholesteremic Agents
  • Apolipoproteins B
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Delayed-Action Preparations
  • Fatty Acids, Monounsaturated
  • Indoles
  • Homocysteine
  • Fluvastatin
  • C-Reactive Protein