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Bempedoic acid for the treatment of dyslipidemia
Joel C Marrs1, Sarah L Anderson1
1Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
Insights
Bempedoic acid effectively lowers LDL-C, offering a vital non-statin option for patients with cardiovascular disease or familial hypercholesterolemia who need additional lipid-lowering therapy beyond statins.
Area of Science:
- Cardiology
- Pharmacology
- Metabolic Diseases
Background:
- Cardiovascular disease (CVD) is a leading global cause of mortality.
- Dyslipidemia, particularly elevated low-density lipoprotein-cholesterol (LDL-C), is a major CVD risk factor.
- Many patients require additional lipid-lowering therapies beyond statins to achieve optimal LDL-C levels.
Purpose of the Study:
- To review the efficacy and safety of bempedoic acid as a non-statin therapy for lowering LDL-C.
- To highlight the role of bempedoic acid, alone and in combination with ezetimibe, for patients with atherosclerotic CVD and familial hypercholesterolemia.
- To discuss the potential impact of the ongoing CLEAR OUTCOMES trial on bempedoic acid's clinical role.
Main Methods:
- Review of clinical trial data demonstrating bempedoic acid's efficacy and safety.
- Analysis of LDL-C reduction percentages achieved with bempedoic acid and bempedoic acid/ezetimibe combination therapy.
- Consideration of FDA approvals and ongoing outcome trials.
Main Results:
- Bempedoic acid inhibits adenosine triphosphate citrate lyase, reducing hepatic LDL-C production.
- Clinical trials show bempedoic acid lowers LDL-C by 15-25%, and up to 38% when combined with ezetimibe.
- Bempedoic acid and its combination with ezetimibe are FDA-approved for specific patient populations requiring additional LDL-C lowering.
Conclusions:
- Bempedoic acid represents a significant advancement in non-statin lipid-lowering therapies.
- The combination of bempedoic acid with ezetimibe offers enhanced LDL-C reduction for eligible patients.
- The CLEAR OUTCOMES trial is anticipated to provide crucial data on bempedoic acid's ability to reduce cardiovascular events.
Abstract:
Cardiovascular disease (CVD) is the leading cause of death worldwide and one key factor associated with the increased CVD risk is dyslipidemia. Statin therapy remains the first-line treatment to manage dyslipidemia, yet many patients do not achieve optimal low-density lipoprotein-cholesterol (LDL-C) levels even after taking moderate- or high-intensity statins; therefore, additional, non-statin therapy is often needed. Bempedoic acid is a prodrug that, once activated, decreases LDL-C levels by the inhibition of adenosine triphosphate citrate lyase in the liver. Five clinical trials have demonstrated the safety and efficacy of bempedoic acid and the bempedoic acid/ezetimibe combination in lowering LDL-C in patients with atherosclerotic CVD and heterozygous familial hypercholesterolemia and also in high-risk primary prevention, and statin-intolerant patients. Bempedoic acid has been demonstrated to lower LDL-C levels by 15-25% in clinical trials and up to 38% when combined with ezetimibe. In 2020, the FDA approved bempedoic acid. Furthermore, the combination of bempedoic acid with ezetimibe is FDA approved for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic CVD who require additional LDL-C lowering after maximally tolerated statin therapy. The ongoing CLEAR OUTCOMES trial aims to evaluate whether bempedoic acid can reduce cardiovascular events in patients with statin intolerance and results will be available in the next 3 years. This outcomes trial will be pivotal for determining the role of bempedoic acid in the non-statin lipid-lowering armamentarium.
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