New Clinical Trial Finds Bempedoic Acid Reduces Risk of Major Cardiovascular Events in Statin-Intolerant Patients
Statin intolerance is a common problem among those with elevated LDL cholesterol levels, as side effects associated with statin use can be severe. Now, a new clinical trial has found that bempedoic acid, an ATP citrate lyase inhibitor, can reduce the risk of major adverse cardiovascular events in statin-intolerant patients.
The CLEAR Outcomes trial, funded in part by Esperion Therapeutics, randomly assigned 13,970 patients who reported being unable or unwilling to take statins due to adverse effects, and who had or were at high risk for cardiovascular disease, to receive 180 mg of bempedoic acid or placebo, taken daily. At the 6 month mark, those taking the study drug had a decrease in their levels that was over 29.2 mg per deciliter more than the placebo group, equating to a 21.1% difference.
The main objective was a four-part composite of major cardiovascular events, which included death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. In a trial involving more than 14,000 statin-intolerant patients with an average follow-up period of 40.6 months, taking bempedoic acid was associated with a 13% lower risk of 4-point major adverse cardiovascular events (MACE). This had a statistically significant effect for myocardial infarction and coronary revascularization, although there was no reduction in death from cardiovascular causes.
The people who were prescribed bempedoic acid experienced a higher incidence of several negative side effects than those taking a placebo. Renal impairment, gout (3.1% with the study drug vs 2.1% with the placebo) and gallstones (2.2% vs 1.2%) were among the events reported, as well as elevated hepatic enzymes, which is likely due to the drug's effect on the liver. No increase in discontinuation was seen as a result of these events.
“The compelling results of the CLEAR Outcomes trial will and should increase the use of bempedoic acid in patients with established atherosclerotic vascular disease and in those at high risk for vascular disease who are unable or unwilling to take statins,” said John Alexander, MD, director of cardiovascular research at the Duke Clinical Research Institute. “It is premature, however, to consider bempedoic acid as an alternative to statins.
0. “Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients | NEJM” nejm.org, 4 Mar. 2023, https://www.nejm.org/doi/full/10.1056/NEJMoa2215024
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