In this study, researchers investigated the effects of bempedoic acid, an ATP citrate lyase inhibitor, on cardiovascular outcomes in patients who were unable or unwilling to take statins due to adverse effects. The study was conducted using a double-blind, randomized, placebo-controlled design with 13,970 patients, of whom 6,992 were assigned to the bempedoic acid group and 6,978 to the placebo group. The primary endpoint was a four-component composite of major adverse cardiovascular events, including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.
After a median follow-up of 40.6 months, the researchers found that bempedoic acid significantly reduced LDL cholesterol levels compared to placebo. Specifically, after 6 months, the reduction in LDL cholesterol levels was greater with bempedoic acid than with placebo by 29.2 mg per deciliter, with a 21.1 percentage point difference in percent reduction favoring bempedoic acid.
The study also found that the incidence of the primary endpoint event was significantly lower in the bempedoic acid group than in the placebo group, with 819 patients (11.7%) versus 927 (13.3%), respectively. Bempedoic acid was associated with lower incidences of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction, fatal or nonfatal myocardial infarction, and coronary revascularization compared to placebo. However, bempedoic acid had no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, or death from any cause.
The study did report some adverse events associated with bempedoic acid, including higher incidences of gout and cholelithiasis and small increases in serum creatinine, uric acid, and hepatic-enzyme levels.
In conclusion, the study found that treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events in statin-intolerant patients. However, the study also highlights the potential for adverse events associated with bempedoic acid. Overall, these findings suggest that bempedoic acid could be a potential treatment option for patients who are unable to tolerate statins, but further research is needed to fully understand its safety and efficacy.
DOI: 10.1056/NEJMoa2215024
Leave a Reply