Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients

Oral bempedoic acid (NEXLETOL^® in the USA; Nilemdo^® in the EU) and the fixed dose combination (FDC) of bempedoic acid/ezetimibe (NEXLIZET^® in the USA; Nustendi^® in the EU) are approved to reduce cardiovascular (CV) risk in statin-intolerant patients who are at high risk for, or have, CV disease. A first-in-class therapy, bempedoic acid inhibits the adenosine triphosphate-citrate lyase enzyme in the cholesterol biosynthesis pathway. In the multinational phase III CLEAR Outcomes trial in statin-intolerant patients, once-daily bempedoic acid 180 mg significantly reduced the risk of the primary endpoint (a four-component major adverse CV event composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) compared with placebo. Bempedoic acid was generally well tolerated and, unlike statins, was associated with a low incidence of musculoskeletal adverse events (AEs). In conclusion, bempedoic acid as a monotherapy or adjunctive to other lipid-lowering therapies expands the treatment options available for the pharmacological reduction of CV risk in statin-intolerant patients, supporting achievement of low-density lipoprotein cholesterol (LDL-C) targets required for CV risk reduction.