Bempedoic acid was associated with reduced major adverse cardiovascular events (MACE) in statin-intolerant primary prevention patients at high cardiovascular risk, according to results from a subgroup analysis of the CLEAR Outcomes trial presented at the American Diabetes Association’s 2023 Scientific Sessions and simultaneously published in JAMA.

The CLEAR Outcomes trial enrolled patients from 1,250 centers in 32 countries, of these 4,206 were at high cardiovascular risk but had not experienced a prior cardiovascular event. The mean age of this primary prevention cohort was 68 years, 59% were female and 66% had diabetes. Participants were randomized to receive either 180 mg daily of oral bempedoic acid (n=2,100) or matching placebo (n=2,106). The primary efficacy measure was the time from randomization to the first occurrence of any component of a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke or coronary revascularization.

In presenting the findings, Steven E. Nissen, MD, MACC, said bempedoic acid was well-tolerated in this primary prevention group of patients who were unable or unwilling to take statins. Specifically, bempedoic acid lowered LDL-C by 21.3% and high-sensitivity C-reactive protein levels by 21.5%. Only small increases in the incidence of gout and cholelithiasis were observed and there was no significant effect on stroke or coronary revascularization.

Additionally, Nissen noted that follow-up for a median of approximately 40 months was associated with a 30% reduction in four-component MACE, a 36% reduction in three-component MACE, and a 39% reduction in MI, a 27% reduction in all-cause mortality, and 39% reduction in cardiovascular death.

There were several limitations to the study, including that it was a secondary analysis of a subgroup within the larger CLEAR Outcomes trial. In addition, study participants were at high risk of a first cardiovascular event and results may not apply to lower-risk populations. However, “these findings suggest that treatment with bempedoic acid in primary prevention patients has the potential to reduce major adverse cardiovascular events,” Nissen said.

Clinical Topics: Dyslipidemia, Nonstatins, Novel Agents, Statins

Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors, C-Reactive Protein, Incidence, Risk Factors, Cardiovascular Diseases, Follow-Up Studies, Random Allocation, Myocardial Infarction, Stroke, Gout, Cholelithiasis

< Back to Listings