Daily Dose: Bempedoic Acid Reduces Risk for MACE in Primary Prevention Population

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On June 27, 2023, we reported on a prespecified subgroup analysis of the primary prevention cohort in the CLEAR Outcomes trial presented at the 83rd Scientific Sessions of the American Diabetes Association.

The study

CLEAR Outcomes, a 13 970-participant study unique for its inclusion of only individuals declaring statin intolerance , was the first to demonstrate the benefits of a non-statin lipid lowering therapy on a 4-point composite of major adverse cardiovascular events (MACE).

For their current exploration, researchers analyzed CLEAR Outcomes data from the 4206 original participants at high risk for CVD but without a prior event. Among this subgroup, 2100 had been randomly assigned to receive bempedoic acid 180 mg daily and 2106 to receive placebo.

The primary outcome of interest for CLEAR Outcomes was first occurrence of any component of the 4-point MACE composite of CV death, nonfatal MI, nonfatal stroke, or coronary revascularization.

The findings

Investigators followed the subgroup for a median of 39.9 months and reported a 30% reduction in relative risk for the primary endpoint of 4-point MACE (adjusted HR, 0.70; 95% CI, 0.55-0.89; P=.002) among participants receiving bempedoic acid vs those receiving placebo. The use of bempedoic acid was associated with a 36% reduction in risk for a 3-point composite of CV death, MI, or stroke (aHR, 0.64; 95% CI, 0.48-0.84; P<.001).

When researchers analyzed the individual components of that composite, they observed a 39% reduction in risk for MI vs placebo (aHR, 0.61; 95% CI, 0.39-0.98), a 39% reduction in risk for CV death (aHR, 0.61; 95% CI, 0.41-0.92), and a 27% reduction in risk for all-cause mortality (aHR = 0.73; 95% CI, 0.54-0.98). They also reported no significant effect of bempedoic acid treatment on risk of stroke or coronary revascularization.

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