Bempedoic acid is associated with a reduction in major adverse cardiovascular events among statin-intolerant primary prevention patients, according to a study published online June 24 in the Journal of the American Medical Association to coincide with the annual meeting of the American Diabetes Association, held from June 23 to 26 in San Diego.
Steven E. Nissen, M.D., from the Cleveland Clinic, and colleagues conducted a masked, randomized trial involving 13,970 statin-intolerant patients, including 4,206 primary prevention patients to determine the effects of bempedoic acid on cardiovascular outcomes. Participants were randomly assigned to oral bempedoic acid or matching placebo (2,100 and 2,106 patients, respectively).
The researchers found that bempedoic acid reduced low-density lipoprotein cholesterol levels by 30.2 mg/dL and high-sensitivity C-reactive protein levels by 0.56 mg/L compared with placebo (reductions of 21.3 and 21.5 percent, respectively). A significant risk reduction was seen in the primary end point of first occurrence of any component of a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization (111 versus 161 events [5.3 versus 7.6 percent; adjusted hazard ratio, 0.70]) during follow-up for a median of 39.9 months. Significant risk reductions were also seen in key secondary end points, including the composite of cardiovascular death, MI, or stroke; MI; cardiovascular death; and all-cause mortality (hazard ratios, 0.64, 0.61, 0.61, and 0.73, respectively).
“Administration of bempedoic acid in patients unable or unwilling to take guideline recommended doses of a statin was associated with a significant reduction in the primary end point, four-component major adverse cardiovascular events,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Esperion Therapeutics, which manufactures bempedoic acid and funded the study.
Steven E. Nissen et al, Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients, JAMA (2023). DOI: 10.1001/jama.2023.9696
Dhruv S. Kazi, Bempedoic Acid for High-Risk Primary Prevention of Cardiovascular Disease, JAMA (2023). DOI: 10.1001/jama.2023.9854
American Diabetes Association
Journal of the American Medical Association
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