Evaluation of the Efficacy and Safety of Bempedoic Acid in Women and Men: Pooled Analyses from Phase 3 Trials.

Background and aims: Sex-specific differences in the response to lipid-lowering therapies have been reported. Here, we assessed the effect of bempedoic acid in women and men using pooled, patient-level data from four phase 3 clinical trials of bempedoic acid.Methods: Patients were grouped into two pools: 1) atherosclerotic cardiovascular disease (ASCVD) and/or het-erozygous familial hypercholesterolemia (HeFH) "on statins" and 2) "low-dose or no statin". Percent changes from baseline to at least week 12 in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), apolipoprotein B (Apo B), and high-sensitivity C-reactive protein (hsCRP), as well as safety, were analyzed by statin pool and sex.Results: Overall, 3623 patients were included (bempedoic acid, 2425; placebo, 1198). Significant reductions in lipid parameters and hsCRP were observed with bempedoic acid vs. placebo in both sexes in the ASCVD and/or HeFH on statins (n = 3009) and the low-dose or no statin (n = 614) pools (p <= 0.002). Compared with men, women had significantly greater placebo-corrected reductions in LDL-C (-21.2% vs.-17.4%; p = 0.044), non-HDL-C (-17.3% vs.-12.1%; p = 0.003), TC (-13.8% vs.-10.5%; p = 0.012), and Apo B (-16.0% vs.-11.3%; p = 0.004) in the ASCVD and/or HeFH on statins pool. Women had similar reductions to men in lipid parameters in the low-dose or no statin pool and hsCRP in both pools. The safety of bempedoic acid was com-parable between sexes.Conclusions: In this pooled analysis, women experienced significant improvements in levels of LDL-C and other lipid parameters with bempedoic acid.