6 Mar 2023 • A new approach to lowering cholesterol with the use of bempedoic acid brought about a significant reduction in cardiovascular events in patients intolerant to statins in the large phase 3 placebo-controlled CLEAR Outcomes trial. The study was simultaneously published online in the New England Journal of Medicine (NEJM).

Trial findings were as follows:

• The CLEAR Outcomes trial included 13,970 patients (48% women) from 32 countries who were unable or unwilling to take statins owing to unacceptable adverse effects and who had, or were at high risk for, cardiovascular disease. They were randomly assigned to oral bempedoic acid, 180 mg daily, or placebo.
• The drug lowered LDL cholesterol by 21% in the study and reduced the composite primary endpoint, including cardiovascular death, myocardial infarction (MI), stroke, or coronary revascularization, by 13%; MI was reduced by 23% and coronary revascularization, by 19%.
• The drug was also well-tolerated in the mixed population of primary and secondary prevention patients unable or unwilling to take statins.

"These findings establish bempedoic acid as an effective approach to reduce major cardiovascular events in statin-intolerant patients," study chair, Steve Nissen, MD, Cleveland Clinic, Ohio, concluded.

Nissen pointed out that while in the current study bempedoic acid was studied as monotherapy, he believes the drug will mainly be used in clinical practice in combination with ezetimibe, a combination shown to reduce LDL by 38%.

Source: Medscape | Read full story