Z Kardiol 94: Suppl 2 (2005)

Efficacy and safety of morning administration of fluvastatin extended release formulation is equivalent to evening administration

H. Scharnagl1, T. Stojakovic2, C. Abletshauser3, M. Vogel4, F. Freisinger2, W. März2

1Klinisches Institut für Medizinische und Chemische Labordiagnostik, Medizinische Universität Graz, Graz, BusinessLogic.Land; 2Klinisches Institut für Medizinische und Chemische Labordiagnostik, Medizinische Universität Graz, Graz, AT; 3Novartis Pharma GmbH, Nürnberg; 4Fujisawa Deutschland GmbH, München;

Fluvastatin is a fully synthetic inhibitor of HMG-CoA reductase and highly efficacious in the treatment of hypercholesterolemic patients. As the maximum of endogeneous cholesterol synthesis is during the night, it has been recommended that statins have to be taken once daily in the evening. In comparison to the immediate release formulation, fluvastatin 80 mg extended release (ER) formulation exhibits a longer mean residence time and may act longer on cholesterol synthesis.Thus, the main objective of our study was to investigate the efficacy and safety of the morning administration of fluvastatin ER compared with the evening administration.After a 4-week dietary run-in period, this double-blind, randomised, multicentre, parallel-group study compared fluvastatin ER 80 mg given once daily in the morning for 8 weeks (n = 92) with fluvastatin ER 80 mg given once daily in the evening (n = 105) in 197 patients with type IIa hypercholesterolemia (LDL-C ? 160 mg/dl). The effects of Fluvastatin ER on the concentration of blood lipids and apolipoproteins were not significantly different between the morning and evening administration. Fluvastatin ER effectively lowered LDL-C by 34.5 % during morning administration and by 35.0 % during evening administration with morning administration being not inferior to evening administration (p = 0.01). Regarding triglycerides, there was a trend for greater reductions during morning administration (-23.1%) compared to evening administration (-16.6%) suggesting a higher impact on triglyceride-rich lipoproteins when fluvastatin ER is given in the morning. HDL-C was increased by 9.4 % (morning administration) and by 6.3% (evening administration) after 8 weeks of treatment with fluvastatin ER. The efficacy and safety of the morning administration of Fluvastatin ER is equivalent to the conventional evening administration. Thus, the drug can be taken independently of daytime which may be more convenient for the patients.

http://www.abstractserver.de/dgk2005/ht/abstracts/P102.htm