Consistency in Efficacy and Safety of Ezetimibe Coadministered with Statins for Treatment of Hypercholesterolemia in Women and Men.

Women are often not treated as aggressively as men to control levels of low-densitylipoprotein cholesterol (LDL-C), despite evidence that women and men realize comparablecardiovascular benefit from lipid-lowering therapy. Statins are the most effective drugscurrently available for treating hypercholesterolemia. Despite the impressive cholesterol-loweringcapacity of statins, however, many patients on statin therapy fail to reach establishedtarget levels of LDL-C. The cholesterol absorption inhibitor, ezetimibe, blocks the intestinalabsorption of dietary and biliary cholesterol, a mechanism of action complementary to thatof statins, which inhibit hepatic cholesterol synthesis. Ezetimibe coadministered with statinsproduces significant incremental reductions in LDL-C compared with statin monotherapy.Four randomized, double-blind, placebo-controlled, balanced-parallel group trialscompared the efficacy and safety of statin monotherapy (lovastatin or pravastatin 10, 20,or 40 mg; simvastatin or atorvastatin 10, 20, 40, or 80 mg) vs. ezetimibe 10 mg plus statin (asabove). A gender subset analysis (women,= 1065; men,= 796) on data pooled across thesefour trials was carried out to determine whether ezetimibe plus statin for the treatment of hypercholesterolemiais equally efficacious in women and men.Compared with statin monotherapy, ezetimibe plus statin demonstrated greater efficacyin reducing blood levels of LDL-C, apolipoprotein B, and triglycerides and raising highdensitylipoprotein cholesterol. The beneficial effects of ezetimibe were comparable in womenand men. The safety profile of subjects receiving ezetimibe plus statin was similar tothat of patients receiving statin monotherapy and similar between the two sexes.Ezetimibe plus statin was more effective than statin alone in improving thelipid profile of patients with hypercholesterolemia and was equally efficacious in womenand men. Ezetimibe plus statin was well tolerated and had a favorable safety profile in bothpatient subgroups. Ezetimibe coadministered with statins, a dual inhibition treatment strategythat targets both cholesterol absorption and synthesis, is an effective therapeutic optionfor women with hypercholesterolemia. [ABSTRACT FROM AUTHOR]