Bempedoic acid efficacy and safety in 7,597 non-diabetic patients, with and without metabolic syndrome, from the randomized, placebo-controlled clear outcomes trial.

Abstract

Background and Aims: Bempedoic acid (BA) reduced LDL-C and cardiovascular (CV) events in 13,970 statin intolerant patients with, or at high risk for, CV disease with LDL-C >=100 mg/dL. Metabolic syndrome (MetS) patients are a high-risk primary prevention cohort and have high rates of progression to diabetes. We evaluated the impact of BA on clinical and laboratory parameters in patients with and without MetS at baseline. Method(s): Comparison of treatment effect was performed in a post-hoc analysis of the primary 4-point major adverse CV event (MACE-4; CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) endpoint. Change in biomarkers (lipids and hsCRP), parameters of glycemia (new-onset diabetes [NOD], HbA1c and fasting glucose), and weight were assessed. Result(s): The analysis included 3,824 patients with MetS (BA N=1,913; placebo N= 1,911) and 3,773 without MetS (BA N= 1,935; placebo N= 1,838). BA reduced the risk of MACE-4 similarly in patients with or without MetS (Table 1). Similar placebo-corrected reductions in LDL-C were observed with BA at 6 months in patients with or without MetS. Patients with MetS experienced a greater placebo-corrected reduction in hsCRP at 6 months than patients without MetS. BA was not associated with an increased risk of NOD, nor significant changes in HbA1c or fasting plasma glucose compared to placebo. Greater mean (95%CI) reduction in weight (kg) from baseline to 36 month was observed for MetS on BA [-1.1 (-1.4,-0.8)] vs placebo [-0.3 (-0.6,-0.0)]. Safety was generally comparable between MetS and treatment groups, with higher rates of hyperuricemia in patients with MetS randomized to BA. [Formula presented] Conclusion(s): Bempedoic acid is a suitable therapy for patients with and without MetS who require additional lipid lowering. In patients with MetS on BA there was a small but significant reduction in weight and hsCRP with no increase in NOD.Copyright © 2024