Efficacy and Safety of Fluvastatin in Women with Primary Hypercholesterolemia

Summary

Women with primary hypercholesterolemia are often considered for lipid-lowering drug therapy at a later age than men. With regard to the prevention of cardiovascular morbidity, women can expect to receive the same benefits from lipid-lowering treatment as men. Thus, it is of interest to evaluate the efficacy, safety and tolerability of the new lipid-lowering agent fluvastatin in women.

A retrospective analysis was made on the basis of data from controlled clinical trials in which 1815 patients were treated with fluvastatin at a daily dose of ⩾ 20mg, and 783 patients received placebo. 782 of the fluvastatin-treated patients (43.1%) and 315 patients on placebo (40.2%) were women. Within these groups, 577 patients (73.8%) treated with fluvastatin and 183 patients receiving placebo (78.4%) were at least 50 years of age.

The effect of fluvastatin 40 mg/day on low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol was more favourable in women than in men. In women, the change from baseline was −26.7% for LDL cholesterol and 5.3% for HDL cholesterol. In men, the equivalent changes from baseline were −23.8% and 4.0%, respectively. All changes from baseline were highly significant (p < 0.001). Fluvastatin lowered triglycerides to a similar extent in women and men (7.1% vs 6.9%, respectively).

More women than men experienced a confirmed increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) when receiving fluvastatin. Such increases were observed for AST in 3 women (0.4%) but no men, and for ALT in 10 women (1.3%) and 2 men (0.2%). In placebo-treated patients, no such increases in AST were observed (irrespective of gender) but increases in ALT were noted in one male patient (0.2%) and one female patient (0.3%). No notable increases in creatine Phosphokinase of > 10 times the upper limit of normal were observed in women. The tolerability of fluvastatin, as assessed by an analysis of adverse events, was not consistently influenced by gender.

In conclusion, an exploratory analysis of the efficacy and safety of fluvastatin suggests that it is effective, safe and well tolerated, irrespective of gender. The observed tendency to enhanced efficacy in women should be further evaluated by use of data from prospective studies in female patients.