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Role of Bempedoic Acid in Dyslipidemia Management
Michael S Kelly1, Elisabeth M Sulaica2, Craig J Beavers3
1Department of Pharmacy Practice, Chapman University School of Pharmacy, Irvine, CA.
Insights
Bempedoic acid effectively lowers LDL-C and cardiovascular risk in patients needing additional lipid-lowering therapy. This novel agent offers a comparable safety profile to placebo, with potential benefits for statin-intolerant individuals.
Area of Science:
- Cardiology
- Pharmacology
- Lipid Metabolism
Background:
- Statins are primary agents for lowering LDL-C and ASCVD risk.
- Nonstatin agents are crucial for high-risk patients or those with heterozygous familial hypercholesterolemia on statins.
- Statin-intolerant patients require alternative LDL-C lowering strategies.
Purpose of the Study:
- To review the lipid-lowering effects of bempedoic acid.
- To assess the safety profile of bempedoic acid and its combination with ezetimibe.
- To evaluate bempedoic acid as an adjunct therapy for LDL-C reduction.
Main Methods:
- Review of lipid-lowering effects from multiple phase 2 and 3 trials.
- Analysis of safety data from clinical trials.
- Evaluation of bempedoic acid in patients with and without statin intolerance.
Main Results:
- Bempedoic acid significantly lowers LDL-C and atherogenic lipoproteins.
- It also reduces high-sensitivity C-reactive protein levels.
- Safety is comparable to placebo, with noted increases in serum uric acid and tendon rupture risk.
Conclusions:
- Bempedoic acid is effective as an adjunct therapy for lowering LDL-C.
- It offers a novel mechanism potentially avoiding statin-associated muscle symptoms.
- Further trials will clarify long-term safety and cardiovascular outcomes.
Abstract:
Statins remain the preferred agent to reduce low-density lipoprotein cholesterol (LDL-C) and lower atherosclerotic cardiovascular disease (ASCVD) risk. Additional nonstatin agents are recommended to further lower LDL-C among patients at high-risk of ASCVD or those with heterozygous familial hypercholesterolemia, despite statin therapy. Patients unable to tolerate recommended doses of statin therapy due to adverse effects, including statin-associated muscle symptoms, may also require additional nonstatin agents to lower LDL-C and ASCVD risk. Bempedoic acid is a first-in-class, once-daily oral agent, recently approved as monotherapy and in combination with ezetimibe, as an adjunct to maximally tolerated statin therapy in patients with ASCVD or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. Its novel mechanism is reported to avoid adverse muscle symptoms associated with statins. The effectiveness and safety of bempedoic acid and bempedoic acid/ezetimibe combination have been reported in multiple phase 2 and 3 trials. In this review, we report the lipid-lowering effects associated with bempedoic acid, and the safety profile from multiple clinical trials. Based on available data, bempedoic acid significantly lowers LDL-C and other atherogenic lipoprotein measures, and high-sensitivity C-reactive protein when added to background lipid-lowering therapy in patients with and without statin intolerance. Overall safety of bempedoic acid seems to be comparable to placebo, except for increased serum uric acid and tendon rupture. Ongoing clinical trials assessing the long-term safety and cardiovascular outcomes will provide additional insight into the role of bempedoic acid as an adjunct lipid-lowering medication.
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