Bempedoic Acid Shows Promise in Reducing Cardiovascular Events for Statin-Intolerant Patients: Subgroup Analysis

The CLEAR Outcomes Trial: Exploring Bempedoic Acid’s Impact on Cardiovascular Events

The CLEAR Outcomes trial, conducted across 1,250 centers in 32 countries, aimed to investigate the efficacy and safety of bempedoic acid in reducing major adverse cardiovascular events (MACE). A subgroup analysis focused on statin-intolerant primary prevention patients at high cardiovascular risk revealed compelling results.

A Closer Look at the Study Cohort and Treatment

The study cohort consisted of 4,206 primary prevention patients, with a mean age of 68 years. The majority were female (59%) and had diabetes (66%). Participants were randomized to receive either 180 mg daily of oral bempedoic acid (n=2,100) or a 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.

Favorable Results and Treatment Tolerability

Presenting the findings, Steven E. Nissen, MD, MACC, highlighted bempedoic acid’s favorable tolerability in this primary prevention group, comprising patients who were unable or unwilling to take statins. The therapy demonstrated a notable reduction in LDL-C levels by 21.3% and high-sensitivity C-reactive protein levels by 21.5%. Notably, the incidence of gout and cholelithiasis increased only slightly, and there were no significant effects on stroke or coronary revascularization.

Long-Term Follow-Up and Reduction in MACE

With a median follow-up of approximately 40 months, the study revealed promising results regarding the reduction of major adverse cardiovascular events (MACE). Bempedoic acid treatment was associated with a 30% reduction in four-component MACE, a 36% reduction in three-component MACE, and a significant 39% reduction in myocardial infarction. Furthermore, the therapy demonstrated a 27% reduction in all-cause mortality and a 39% reduction in cardiovascular death.

Study Limitations and Implications

Despite the encouraging findings, it is important to consider the limitations of this study. The subgroup analysis was conducted within the larger CLEAR Outcomes trial, and the study participants were specifically high-risk individuals at risk of a first cardiovascular event. As such, the results may not be directly applicable to lower-risk populations. Nevertheless, these findings provide