The American journal of medicine
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Fluvastatin administration at bedtime versus with the evening meal: a multicenter comparison of bioavailability, safety, and efficacy.
Fluvastatin is a totally synthetic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is effective in reducing cholesterol when given in a single evening dose. Absorption and rate of bioavailability may be affected when administered with food, but the effect of mealtime dosing on efficacy and safety has not been evaluated. This multicenter, double-blind, placebo-controlled crossover study was performed in 44 patients with primary hypercholesterolemia. ⋯ With fluvastatin, there were comparable reductions in total cholesterol (p < 0.001) and in LDL:high-density lipoprotein (HDL) ratio (p < 0.001) irrespective of the time of dosing. In conclusion, fluvastatin had a similar tolerability, safety, and efficacy, whether given with the evening meal or at bedtime. There were no serious adverse events nor changes in physical examination findings or laboratory values attributable to treatment.