Bempedoic Acid: An LDL-C Lowering Therapy to Reduce Cardiac Event Risk in Statin-Intolerant Patients
Bempedoic acid, an LDL-C lowering therapy, has been proven to reduce the risk of serious cardiac events in statin-intolerant patients. A new study recently published in the New England Journal of Medicine, the CLEAR Outcomes trial, found that the drug had a significant impact in reducing the risk of cardiovascular death, heart attack, stroke or coronary revascularization in statin-intolerant patients.
The study included 13,970 statin-intolerant patients from 1,250 sites in 32 countries. Participants were randomly assigned to take either 180 mg of bempedoic acid or a placebo daily, and were followed for an average of over 3 years. Researchers found that the incidence of a primary endpoint event was significantly lower with bempedoic acid than with placebo (11.7% vs. 13.3%; hazard ratio, 0.87). The incidences of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (HR, 0.85); fatal or nonfatal myocardial infarction (HR, 0.77); and coronary revascularization (HR, 0.81) were also significantly lower with bempedoic acid than with placebo.
In addition, the NEXLETOL trial, which studied a combination of bempedoic acid and ezetimibe, found that the drug significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, as compared to placebo.
Furthermore, the STOP-CA trial found that prophylactic atorvastatin therapy significantly reduced the incidence of anthracycline-associated left ventricular dysfunction at 12 months among patients who underwent treatment for lymphoma (9% vs. 22%; OR = 2.9; 95% CI, 1.4-6.4).
These findings suggest that bempedoic acid may be an effective alternative for patients who cannot tolerate statins, as well as those at high risk for vascular disease who are unable or unwilling to take statins. However, it is important to note that while bempedoic acid may be effective, statins remain the cornerstone of risk reduction in patients with elevated LDL cholesterol.
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. “Cleveland Clinic-Led Trial Shows That The First Drug Designed for Statin-Intolerant Patients Reduces Serious Cardiovascular Events” Cleveland Clinic Newsroom, 4 Mar. 2023, https://newsroom.clevelandclinic.org/2023/03/04/cleveland-clinic-led-trial-shows-that-the-first-drug-designed-for-statin-intolerant-patients-reduces-serious-cardiovascular-events/
2. “Cholesterol drug lowers heart attack risk; avoids muscle side effects” The Washington Post, 4 Mar. 2023, https://www.washingtonpost.com/wellness/2023/03/04/bempedoic-acid-cholestrol-statins-side-effects/
3. “Landmark CLEAR Outcomes Study Demonstrates NEXLETOL® (bempedoic acid) Tablet is the Only LDL-C Lowering Therapy Since Statins to Reduce Hard Ischemic Events in a Broad Population of Both Primary Prevention and Secondary Prevention Patients” Yahoo Life, 4 Mar. 2023, https://www.yahoo.com/lifestyle/landmark-clear-outcomes-study-demonstrates-153000166.html
4. “Statins May Help Lessen Effects of Cardiac Damage from Anthracyclines” MD Magazine, 4 Mar. 2023, https://www.hcplive.com/view/statins-help-lessen-effects-cardiac-damage-anthracyclines