Bempedoic acid was generally well tolerated and led to glycemic parameter improvement and greater low-density lipoprotein cholesterol (LDL-C) reduction in patients with metabolic syndrome (MetS), according to a poster presented at the National Lipid Association (NLA) Scientific Sessions 2022, held in Scottsdale, Arizona, between June 2nd and June 5th, 2022.
The findings are based on a pooled analysis of 4 phase 3 studies of 3623 patients, of whom 1114 with diabetes were excluded. The participants were randomized 2:1 to bempedoic acid or placebo and were grouped by baseline metabolic status. MetS was defined according to modified International Atherosclerosis Society guidelines with body mass index as a proxy for waist circumference.
Among the 936 patients with MetS, 648 received bempedoic acid and 288 received placebo. Of the 1573 patients without MetS, 1037 received bempedoic acid and 536 received placebo.
The participants were assessed for the percentage change in LDL-C at week 12, as well as changes in total cholesterol (TC), non–high-density lipoprotein cholesterol (HDL)-C, apolipoprotein B (Apo B), high-sensitivity C-reactive protein (hsCRP), triglycerides (TG), and changes in fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) at week 12. Safety assessments were investigator-reported.
Of the patients with MetS, those who received bempedoic acid had a mean age of 63.7 ± 9.1 years, and 67.3% were male; those who received placebo had a mean age of 64.2 ± 9.0 years and 67.7% were male. Of the participants without MetS, those who received bempedoic acid had a mean age of 65.8 ± 9.7 years and 65.8% were male; those who received placebo had a mean age of 66.2 ± 9.3 years and 64.2% were male. More than 90% of participants in all groups were White.
The placebo-corrected least squares mean in LDL-C percentage change at week 12 was significant for bempedoic acid (P <.0001) regardless of MetS status and was significantly more pronounced (interaction P = .0472) in patients with MetS compared with those without MetS.
The placebo-corrected least squares mean in percentage change at week 12 for TC, non–HDL-C, TG, and Apo B was significant (P ≤.02) for patients with and without MetS (interaction P =.523, P =.451, P < 0.0001, and P =.530, respectively).
The median difference at week 12 for hsCRP was significant for patients with and without MetS (with MetS, –17.9 [–25.1, –10.7], P <.0001; without MetS, –19.9 [–26.5, –13.2], P <.0001; interaction P =.965 in the log scale).
The placebo-corrected least squares mean percentage change at week 12 for HbA1c and FPG was significant for patients with MetS (HbA1c, −0.07 [−0.10, −0.04], P < .0001; FPG, −2.4 [−4.0, −0.9], P =.002) and insignificant for patients without MetS (interaction P =.0003 and P =.002, respectively).
The bempedoic acid safety profile was similar in patients with or without MetS. The incidence of treatment emergent adverse events (TEAEs) were comparable between the placebo and bempedoic acid groups. Nasopharyngitis was the most common TEAE in all 4 groups.
“Bempedoic acid was associated with significant decreases in LDL-C, TC, non–HDL-C, Apo B, and hsCRP regardless of the presence or absence of MetS,” stated the investigators. “Bempedoic acid lowered LDL-C levels to a greater extent in patients with MetS compared with patients without MetS.”
Disclosure: Clinical trials included in this analysis were funded by Esperion Therapeutics, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Shapiro MD, Taub PR, Louie MJ, Lei L, Ballantyne CM. Efficacy and safety of bempedoic acid in patients with metabolic syndrome. Poster presented at: National Lipid Association (NLA) Scientific Sessions 2022; June 2-5, 2022; Scottsdale, Arizona.