New Study Shows Bempedoic Acid Reduces Risk of Cardiovascular Events in Statin-Intolerant Patients

A new study published in the New England Journal of Medicine found that bempedoic acid, a drug developed by Esperion Therapeutics, Inc., can reduce the risk of major cardiovascular events in patients who cannot tolerate statins. The study, led by cardiologist Steven E. Nissen, M.D., of Cleveland Clinic, enrolled 13,970 statin-intolerant patients across 32 countries and found that those taking bempedoic acid had a 13% lower risk of major adverse cardiovascular events (MACE) and a 15% lower risk of MACE-3.^[0] Additionally, this group had a 23% lower risk of heart attack and a 19% lower risk of coronary revascularization.^[1]

The primary endpoint of the study was the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.^[0] At baseline, the mean LDL-C level was 139 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 observed difference in the percent reductions was 21.1 percentage points in favor of bempedoic acid.^[2] The incidence of a primary end-point event was significantly lower with bempedoic acid than with placebo (11.7% vs. 13.3%, respectively; hazard ratio, 0.87; 95% confidence interval [CI], 0.79 to 0.96; P=0.004).^[3]

Though bempedoic acid was found to be an effective alternative for statin-intolerant patients, it is not an alternative to statins. “Given the overwhelming evidence of the vascular benefits of statins, clinicians should continue their efforts to prescribe them at the maximum tolerated doses for appropriate patients, including those who may have discontinued statins because of presumed side effects,” said John H. Alexander, MD, MHS, in an accompanying editorial in the New England Journal of Medicine.^[0]

Bempedoic acid works in a similar way that statins do, by drawing cholesterol out of plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. The drug is activated only in the liver, unlike a statin, so it is unlikely to cause muscle aches.^[4]

0. “Clear CVD Benefit With Bempedoic Acid: CLEAR Outcomes” TCTMD, 4 Mar. 2023, https://www.tctmd.com/news/clear-cvd-benefit-bempedoic-acid-clear-outcomes

1. “Bempedoic Acid, Approved to Treat LDL Cholesterol, Cuts Risk of Major CV Events by 13%” AJMC.com Managed Markets Network, 4 Mar. 2023, https://www.ajmc.com/view/bempedoic-acid-approved-to-treat-ldl-cholesterol-cuts-risk-of-major-cv-events-by-13-

2. “Bempedoic Acid Reduces Risk of MACE by 13%, But Proves No Benefit on Cardiovascular Death” MD Magazine, 4 Mar. 2023, https://www.hcplive.com/view/bempedoic-acid-reduces-risk-of-mace-by-13-but-proves-no-benefit-on-cardiovascular-death

3. “Bempedoic acid: A potential statin alternative shows promise to help heart health” CNN, 4 Mar. 2023, https://www.cnn.com/2023/03/04/health/bempedoic-acid-heart-statin-intolerance-study/index.html

4. “Study shows heart patients who can’t take statins now have an effective option” cleveland.com, 4 Mar. 2023, https://www.cleveland.com/news/2023/03/study-shows-heart-patients-who-cant-take-statins-now-have-an-effective-treatment-option.html