Efficacy and safety of fluvastatin, a new HMG CoA reductase inhibitor, in elderly hypercholesterolaemic women.

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 40 mg 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 > or = 20% for LDL cholesterol. Triglycerides were reduced by 16% (not significant).(ABSTRACT TRUNCATED AT 250 WORDS)