TY - JOUR
T1 - Evaluation of the efficacy and safety of bempedoic acid in women and men
T2 - Pooled analyses from phase 3 trials
AU - Goldberg, Anne C.
AU - Banach, Maciej
AU - Catapano, Alberico L.
AU - Duell, P. Barton
AU - Leiter, Lawrence A.
AU - Hanselman, Jeffrey C.
AU - Lei, Lei
AU - Mancini, G. B.John
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/11
Y1 - 2023/11
N2 - 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 heterozygous 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 comparable between sexes. Conclusions: In this pooled analysis, women experienced significant improvements in levels of LDL-C and other lipid parameters with bempedoic acid.
AB - 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 heterozygous 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 comparable between sexes. Conclusions: In this pooled analysis, women experienced significant improvements in levels of LDL-C and other lipid parameters with bempedoic acid.
KW - Atherosclerotic cardiovascular disease
KW - Hyperlipidemia
KW - Sex-specific responses
KW - Women
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U2 - 10.1016/j.atherosclerosis.2023.117192
DO - 10.1016/j.atherosclerosis.2023.117192
M3 - Article
C2 - 37648637
AN - SCOPUS:85171327804
SN - 0021-9150
VL - 384
JO - Atherosclerosis
JF - Atherosclerosis
M1 - 117192
ER -