Response by Sex to Statin and Ezetimibe Versus Statin Monotherapy: Pooled Analysis from 22,913 Hyperlipidemic Patients

Abstract

Synopsis: Coronary heart disease (CHD) remains the leading cause of mortality in women, highlighting the importance of preventive interventions in women. Purpose: To assess sex-related efficacy of statin + ezetimibe (EZ) vs statin in a broad, pooled database. Methods: Data were pooled from 27 double-blind, active, or placebo-controlled studies that randomized adult patients with hypercholesterolemia to statin alone or statin + EZ. Consistency of treatment effect among sexes was tested with ANCOVA with terms for treatment, first/second-line therapy status (FSLT), race, sex, CHD, statin potency, age, body mass index, baseline (BL) low-density lipoprotein cholesterol, BL high-density lipoprotein cholesterol (HDL-C), BL triglycerides, BL response variable, diabetes, trial within FSLT, treatment by FSLT, and treatment by sex interactions. Results: BL lipids and high-sensitivity C-reactive protein (hs-CRP) were generally greater in women than men. Both therapies significantly reduced low-density lipoprotein cholesterol, non-HDL-C, TG, apoB, TC, and hs-CRP, with significantly greater reductions seen with statin + EZ vs statin for prespecified dose comparisons. In general, treatment group differences for women were slightly smaller. HDL-C increased more for women than men in both treatment groups. There were no between-group differences in adverse events or creatine kinase elevations in the overall population. A greater incidence of alanine aminotransferase elevations was seen in statin + EZ vs statin patients in the overall population (0.6% vs 0.3%). Some minor differences, although not clinically relevant, were noted between sexes in the incidence of some AEs. Conclusions: This pooled database describes a large clinical experience with statin + EZ for women in which significantly greater changes in lipid and hs-CRP levels were seen with statin + EZ vs statin in both sexes, although women experienced smaller reductions than men for some lipids. Both treatments were generally well tolerated without major sex-related safety issues. ErratumJournal of Clinical LipidologyVol. 4Issue 4PreviewIn the June 2010 issue (4/3) of Journal of Clinical Lipidology, in the section titled “Scientific Poster Abstracts Selected for the National Lipid Association 2010 Annual Scientific Sessions” (2010;4:198-231), changes were made post-submission as noted below. Full-Text PDF