title: Efficacy and safety of fluvastatin-extended release in hypercholesterolemic patients: morning administration is equivalent to evening administration.
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.
authors.affiliation: Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University, Graz, Austria. hubert.scharnagl@klinikum-graz.at
authors.forename: Hubert
authors.initials: H
authors.lastname: Scharnagl
authors.forename: Monika
authors.initials: M
authors.lastname: Vogel
authors.forename: Claudia
authors.initials: C
authors.lastname: Abletshauser
authors.forename: Franz
authors.initials: F
authors.lastname: Freisinger
authors.forename: Tatjana
authors.initials: T
authors.lastname: Stojakovic
authors.forename: Winfried
authors.initials: W
authors.lastname: März
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001055:Apolipoproteins B / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D002940:Circadian Rhythm; D003692:Delayed-Action Preparations; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000077340:Fluvastatin; D006710:Homocysteine / Q000097:blood; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003692:Delayed-Action Preparations; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D006710:Homocysteine; D000077340:Fluvastatin; D002097:C-Reactive Protein