EFFICACY AND SAFETY OF FLUVASTATIN IN WOMEN WITH PRIMARY HYPERCHOLESTEROLEMIA

Women with primary hypercholesterolaemia are often considered for lipi d-lowering drug therapy at a later age than men. With regard to the pr evention of cardiovascular morbidity, women can expect to receive the same benefits from lipid-lowering treatment as men. Thus, it is of int erest to evaluate the efficacy, safety and tolerability of the new lip id-lowering agent fluvastatin in women. A retrospective analysis was m ade on the basis of data from controlled clinical trials in which 1815 patients were treated with fluvastatin at a daily dose of greater tha n or equal to 20mg, and 783 patients received placebo. 782 of the fluv astatin-treated patients (43.1%) and 315 patients on placebo (40.2%) w ere women. Within these groups, 577 patients (73.8%) treated with fluv astatin and 183 patients receiving placebo (78.4%) were at least 50 ye ars of age. The effect of fluvastatin 40 mg/day on low density lipopro tein (LDL) and high density lipoprotein (HDL) cholesterol was more fav ourable 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 eq uivalent changes from baseline were -23.8% and 4.0%, respectively. All changes from baseline were highly significant (p < 0.001). Fluvastati n lowered triglycerides to a similar extent in women and men (7.1% vs 6.9%, respectively). More women than men experienced a confirmed incre ase 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 ob served (irrespective of gender) but increases in ALT were noted in one male patient (0.2%) and one female patient (0.3%). No notable increas es in creatine phosphokinase of > 10 times the upper limit of normal w ere observed in women. The tolerability of fluvastatin, as assessed by an analysis of adverse events, was not consistently influenced by gen der. 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 i n women should be further evaluated by use of data from prospective st udies in female patients.