How the CLEAR Outcomes Trial Made CV Risk Reduction History, with Lead Investigator Steven Nissen, MD

Bempedoic acid (Nexletol; Esperion) and bempedoic acid with ezetimibe (Nexlizet; Esperion) were awarded broad new label expansions in March 2024 that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention populations. The label enhancements also support the use of the nonstatin and nonstatin combination either as monotherapy or in combination with statin medications. They are the only LDL-C lowering nonstatin medications indicated for primary CVD prevention.

The significant expansions for CVD risk reduction are based on the US Food and Drug Administration review of data from the pivotal CLEAR Outcomes trial, published in the New England Journal of Medicine. Patient Care spoke with CLEAR Outcomes lead investigator Steven Nissen, MD, and asked him to describe the study, its results, and how the new labeling reflects those findings.

Nissen is Chief Academic Officer, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH and the primary investigator for the bempedoic acid and bempedoic acid plus ezetimibe clinical trial program.