Efficacy and safety of fluvastatin-extended release in hypercholesterolemic patients: morning administration is equivalent to evening administration.
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.
Scharnagl
Hubert
H
Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University, Graz, Austria. hubert.scharnagl@klinikum-graz.at
Vogel
Monika
M
Abletshauser
Claudia
C
Freisinger
Franz
F
Stojakovic
Tatjana
T
März
Winfried
W
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
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