LDL-C lowering with bempedoic acid reduces cardiovascular events in high-risk population

The use of bempedoic acid helps lower low-density lipoprotein cholesterol (LDL-C) levels and subsequently reduce cardiovascular events in individuals at high cardiovascular risk, according to the CLEAR* Outcomes trial.

CLEAR Outcomes included 13,970 patients (mean age 65 years, 51.8 percent male) at high risk of cardiovascular disease, hypercholesterolemia, and who could not tolerate statins. These patients were randomly assigned to receive bempedoic acid or placebo daily.

Researchers recorded the time to first event for a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization (MACE-4) as the primary endpoint. The key secondary endpoint was time to first event for cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (MACE-3).

Most of the patients (69.9 percent) had prior atherosclerotic cardiovascular disease and a baseline LDL-C level of 139 mg/dL. After 6 months of treatment, patients in the bempedoic acid group had 21-percent lower LDL-C levels and 22-percent reduced high-sensitivity C-reactive protein (hsCRP) levels.

Over a median follow-up of 3.4 years, 1,746 positively adjudicated first MACE-4 events and 915 additional MACE events occurred in 612 patients. Coronary revascularization accounted for 32.8 percent of first events and 69.4 percent of additional events.

Looking at the total incidence of cardiovascular events, bempedoic acid treatment conferred a significant reduction in the risk of MACE-4 (hazard ratio [HR], 0.80, 95 percent confidence interval [CI], 0.72–0.89; p<0.001), MACE-3 (HR, 0.83, 95 percent CI, 0.73–0.93; p=0.002), myocardial infarction (HR, 0.69, 95 percent CI, 0.58–0.83; p<0.001), and coronary revascularization (HR, 0.78, 95 percent CI, 0.68–0.89; p<0.001). Treatment had a null effect on the risk of stroke (HR, 0.80, 95 percent CI, 0.63–1.03).

Bempedoic acid had a greater protective effect in patients with more MACE events.

*Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen