Approved in 2020 as Nexletol, bempedoic acid as the first ATP citrate lyase inhibitor and oral non-statin therapy to meet the MACE-4 primary endpoint.
Topline findings announced on December 7 from the landmark phase 3 Cholesterol Lowering via Bempedoic acid cardiovascular outcomes (CLEAR) trial confirm that bempedoic acid (Nexletol®, Esperion) is associated with statistically significant and clinically meaningful reductions in risk for major adverse cardiovascular events (MACE).
Stating in a news release that the company will present comprehensive CLEAR trial data at a key medical conference in the first quarter of 2023, manufacturer Esperion says that the pivotal study confirms bempedoic acid as the first ATP citrate lyase inhibitor and first oral non-statin medication to meet the MACE-4 primary endpoint, which includes cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, and unstable angina requiring hospitalization.
Meeting that endpoint makes bempedoic acid the first drug of its kind for treatment of patients in whom “ existing lipid lowering therapies fall short,” said Sheldon Koenig, Esperion president and CEO in the news release. “We look forward to sharing this data with the medical community and submitting to appropriate regulatory authorities as quickly as possible in 2023.”
The US Food and Drug Administration approved bempedoic acid in 2020 with an indication as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic CV disease (ASCVD) who require additional lowering of LDL-C. Approved labeling is based on phase 3 trial findings that demonstrated an 18% reduction in LDL-C when bempedoic acid is used as an adjunct to maximally tolerated statin therapy and a 28% reduction when used in patients intolerant of statin drugs.
CLEAR Outcomes was designed to augment data on the lipid-lowering benefits of bempedoic acid with findings on the drug’s ability to reduce risk for MACE in patients with or at high risk for CVD who have documented statin intolerance and fasting blood LDL-C levels≥100 mg/dL. The trial enrolled more than 14 000 international participants.
“CLEAR Outcomes further strengthens the clinical evidence supporting the role of bempedoic acid for patients,” said Koenig. “We thank the thousands of patients and investigators worldwide for bringing this study to a successful close.”