Commentary
Article
Bempedoic acid is an effective option for statin-intolerant patients or those needing additional low-density lipoprotein cholesterol (LDL-C) reduction, with clinical trials showing cardiovascular benefits, key drug-drug interaction considerations, and special management factors in patients with comorbidities.
Bempedoic acid (Nexletol; Esperion Therapeutics) has emerged as an important option in the lipid-lowering landscape, particularly for patients who are statin-intolerant or require additional low-density lipoprotein cholesterol (LDL-C) reduction to achieve treatment targets. At the National Lipid Association (NLA) 2025 Scientific Sessions, Steven E. Nissen, MD, MACC, chief academic officer for the Heart, Vascular and Thoracic Institute at the Cleveland Clinic, the Lewis and Patricia Dickey chair in cardiovascular medicine, and professor of medicine at the Cleveland Clinic Lerner College of Medicine, shared insights into the clinical trial data supporting bempedoic acid’s efficacy, the ideal patient populations for its use, potential drug-drug interactions, and key considerations for pharmacists managing patients with comorbidities. In this interview with Pharmacy Times®, Nissen highlights the evolving role of bempedoic acid in cardiovascular risk management and the importance of individualized therapy in optimizing patient outcomes.
Pharmacy Times: Can you summarize the key clinical data supporting the efficacy of bempedoic acid in lowering LDL-C, particularly in patients who are statin-intolerant or have atherosclerotic cardiovascular disease (ASCVD)?
Steven E. Nissen, MD, MACC, is chief academic officer for the Heart, Vascular and Thoracic Institute at the Cleveland Clinic, the Lewis and Patricia Dickey chair in cardiovascular medicine, and professor of medicine at the Cleveland Clinic Lerner College of Medicine in Ohio.
Steven E. Nissen, MD, MACC: The CLEAR Tranquility trial [NCT03001076] established that bempedoic acid could lower LDL-C up to 28.% in statin intolerant patients. The CLEAR Harmony trial [NCT02666664] established that bempedoic acid could also lower LDL-C in patients on maximally tolerated statin therapy. The largest of these trials, CLEAR Outcomes [NCT02988115] showed that bempedoic acid could lower LDL-C and reduce cardiovascular events in patients unable to tolerate statins.
Pharmacy Times: What patient populations do you see as the ideal candidates for bempedoic acid therapy in clinical practice?
Nissen: Patients who are statin intolerant and for whom an additional 20% to 25% reduction in LDL-C is needed to reach treatment goals.
Pharmacy Times: Could you discuss any observed or potential drug-drug interactions with bempedoic acid that pharmacists should be aware of, especially in patients on polypharmacy regimens?
Nissen: There are moderate increases in blood levels of simvastatin [Zocor; Merck & Co] and pravastatin [Pravachol; Bristol Myers Squibb] with bempedoic acid administration. This is not an issue when the drug is administered to statin intolerant patients.
Bempedoic acid molecular structure. Image Credit: © Сергей Шиманович - stock.adobe.com
Pharmacy Times: What does the data suggest about the long-term cardiovascular outcomes associated with bempedoic acid use, and are there ongoing trials exploring this further?
Nissen: The CLEAR Outcomes trial established the benefits of bempedoic acid in both primary and secondary prevention populations intolerant to statins. The overall hazard ratio [HR] for major cardiovascular events was 0.87 (P=0.004). However, the HR for myocardial infarction was 0.77 (P=0.002) and 0.81 for coronary revascularization (P=0.001).
Pharmacy Times: Are there any special considerations for bempedoic acid use in patients with comorbidities such as diabetes, chronic kidney disease, or liver disease?
Nissen: Yes, there is a slight increased risk of gout and a reversible increase in creatinine that does not represent a reduction in estimated glomerular filtration rate.
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