EFFICACY AND SAFETY OF FLUVASTATIN, A NEW HMG COA REDUCTASE INHIBITOR, IN ELDERLY HYPERCHOLESTEROLEMIC WOMEN

This multicentre open 6-week study evaluated the efficacy, safety and tolerability of fluvastatin, the first fully synthetic 3-hydroxy-3-met hylglutaryl coenzyme A (HMG CoA) reductase inhibitor, in elderly women with type IIa hypercholesterolaemia. After a 4-week single-blind plac ebo period, 22 elderly women (mean age 68 +/- 5 years) with primary hy percholesterolaemia [low density lipoprotein (LDL) cholesterol > 160 m g/dl] were enrolled in the trial. Fluvastatin 40mg was administered on ce in the evening. At baseline, and after 3 and 6 weeks of treatment, total cholesterol, LDL cholesterol, high density lipoprotein (HDL) cho lesterol, triglycerides, apolipoproteins B (apo B) and A-I (apo A-I) w ere measured. Safety and tolerability were assessed by monitoring rout ine laboratory parameters and by recording spontaneously reported side effects. The mean (+/- SD) baseline total cholesterol, LDL cholestero l, 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 leve ls by 22%, 29% and 23%, respectively. These significant reductions wer e 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 greater than or equal to, 20% for LDL cholesterol. Triglycerides were reduced by 16% (not significant). No clinically si gnificant modifications in safety parameters or in the plasma concentr ations of aspartate and alanine amino transferases, or creatine phosph okinase were observed during the study. Mild and transient drug-relate d side effects (gastrointestinal complaints) were reported in 2 cases. No patient discontinued the study because of adverse events. Muscle-r elated symptoms were not reported. Thus, fluvastatin 40mg once daily i s efficacious, safe and well tolerated in the treatment of primary hyp ercholesterolaemia in elderly women.