Efficacy and safety of fluvastatin in women with primary hypercholesterolaemia.

Women with primary hypercholesterolaemia 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 > or = 20 mg, 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.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes