Bempedoic acid (Nexletol, Esperion) use has emerged as an effective approach to reduce major cardiovascular events in statin-intolerant patients, according to a recent study published in the prestigious ‘New England Journal of Medicine’. The study reported that bempedoic acid brought about a significant reduction in cardiovascular events in a large phase 3 placebo-controlled CLEAR Outcomes trial.

      The double-blind, randomized, placebo-controlled trial was conducted in patients who were unable or unwilling to take statins due to unacceptable adverse effects (“statin-intolerant” patients) and had, or were at high risk for, cardiovascular disease. The study enrolled a total of 13,970 patients, with 6992 assigned to the bempedoic acid group and 6978 to the placebo group. The median duration of follow-up was 40.6 months.

      Patients in the bempedoic acid group received oral bempedoic acid, 180 mg daily. The primary end point was a four-component composite of major adverse cardiovascular events, including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.

      The results showed that bempedoic acid lowered LDL cholesterol by 21%, myocardial infarction (MI) by 23%, and coronary revascularization by 19%. The mean LDL cholesterol level at baseline was 139.0 mg/dL in both groups, and after 6 months, the reduction in the level was greater with bempedoic acid than with placebo by 29.2 mg/dL.

      The researchers also noted that the drug was well-tolerated in the mixed population of primary and secondary prevention patients who were unable or unwilling to take statins. The study chair, Steve Nissin of Cleveland Clinic, opined that the findings establish bempedoic acid as an effective approach to reduce major cardiovascular events in statin-intolerant patients.

      The study's findings have significant implications for patients who are unable or unwilling to take statins due to intolerable adverse effects, as bempedoic acid can offer a viable alternative approach to reducing cardiovascular events.