Efficacy and Safety of Fluvastatin, a New HMG CoA Reductase Inhibitor, in Elderly Hypercholesterolaemic Women

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Abstract

Summary

This multicentre open 6-week study evaluated the efficacy, safety and tolerability of fluvastatin, the first fully synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor, in elderly women with type IIa hypercholesterolaemia. After a 4-week single-blind placebo period, 22 elderly women (mean age 68 ± 5 years) with primary hypercholesterolaemia [low density lipoprotein (LDL) cholesterol > 160 mg/dl] were enrolled in the trial. Fluvastatin 40mg was administered once in the evening. At baseline, and after 3 and 6 weeks of treatment, total cholesterol, LDL cholesterol, high density lipoprotein (HDL) cholesterol, triglycerides, apolipoproteins B (apo B) and A-I (apo A-I) were measured. Safety and tolerability were assessed by monitoring routine laboratory parameters and by recording spontaneously reported side effects. The mean (± SD) baseline total cholesterol, LDL cholesterol, triglyceride, HDL cholesterol, apo B and apo A-I levels were 325 ± 43, 236 ± 43, 128 ± 56, 61 ± 16, 221 ± 60 and 164 ± 28 mg/dl, respectively.

After 6 weeks, fluvastatin significantly (p < 0.001, ANOVA test) reduced total cholesterol, LDL cholesterol and apo B levels by 22%, 29% and 23%, respectively. These significant reductions were already reached at week 3 (total cholesterol, -21%; LDL cholesterol, -27%). The total cholesterol: HDL cholesterol ratio was reduced by 22% at week 3 and by 21% at week 6 (from 5.3 to 4.2). 78% of the patients showed a reduction ≥ 20% for LDL cholesterol. Triglycerides were reduced by 16% (not significant). No clinically significant modifications in safety parameters or in the plasma concentrations of aspartate and alanine amino transferases, or creatine phosphokinase were observed during the study. Mild and transient drug-related side effects (gastrointestinal complaints) were reported in 2 cases. No patient discontinued the study because of adverse events. Muscle-related symptoms were not reported.

Thus, fluvastatin 40mg once daily is efficacious, safe and well tolerated in the treatment of primary hypercholesterolaemia in elderly women.

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