Efficacy and Safety of Bempedoic Acid in Patients With and Without Metabolic Syndrome: Pooled Analysis of Data From Four Phase 3 Clinical Trials

Abstract

AbstractBackground and aimsBempedoic acid significantly lowers low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia but its effects in patients with metabolic syndrome (MetS) have not been well characterized. We sought to determine the efficacy and safety of bempedoic acid in patients with hypercholesterolemia by baseline MetS status.MethodsThis study used pooled data from four phase 3 studies. Using modified International Atherosclerosis Society guidelines, patients were grouped into two pools: those with and those without MetS. Patients with diabetes were excluded. Endpoints assessed change from baseline to week 12 in lipid and glycemic parameters and high-sensitivity C-reactive protein (hsCRP), and safety.ResultsThe study included 936 patients with MetS (bempedoic acid, 648; placebo, 288) and 1573 without MetS (bempedoic acid, 1037; placebo, 536). Significant placebo-corrected reductions in LDL-C were observed with bempedoic acid (p<0.0001), with a greater decrease in patients withvs. without MetS (−22.3%vs. −18.4%; interactionp=0.0472). Compared with placebo, bempedoic acid significantly (p<0.0001) lowered total cholesterol, non–high-density lipoprotein cholesterol, apolipoprotein B, and hsCRP, with a similar magnitude of benefit observed between MetS categories. Significant reductions in triglycerides (−4.4%;p=0.02) were only observed in patients without MetS; only patients with MetS experienced decreases in glycated hemoglobin (−0.07%;p<0.0001) and fasting plasma glucose (−2.4 mg/dL;p=0.002). Safety was comparable between MetS categories and treatment groups.ConclusionsThese data suggest that bempedoic acid is a suitable therapy for patients with MetS who require additional lipid lowering.HighlightsBempedoic acid lowered LDL-Cvs. placebo in patients with and without MetS.Placebo-corrected LDL-C reductions were greater in patients withvs. without MetS.Bempedoic acid lowered TC, non–HDL-C, ApoB, and hsCRP regardless of MetS category.Reductions in HbA1c and FPGvs. placebo were only observed in patients with MetS.Bempedoic acid safety was comparable between MetS categories.