Safety and efficacy of bempedoic acid: a systematic review and meta-analysis of randomised controlled trials
Open accessAbstract
Background and aims: Bempedoic Acid (BA) is a novel Lipid-Lowering Therapy (LLT). We performed a systematic review and meta-analysis to assess the efficacy and safety of BA in patients with hypercholesterolemia. Methods: PubMed, Scopus, and Cochrane library databases were searched for randomised controlled trials evaluating the efficacy and/or safety of BA compared with placebo. Trials investigating dosages other than 180 mg/die were excluded. Major adverse cardiovascular events (MACE) were the primary efficacy endpoint. LDL-cholesterol reduction was the primary laboratory endpoint. Pre-specified safety endpoints included muscle-related adverse events, new-onset diabetes, and gout. The protocol was registered on PROSPERO (temporary ID:399,867). Results: Study search identified 275 deduplicated results. 11 studies, encompassing 18,315 patients (9854 on BA vs 8461 on placebo/no treatment) were included. BA was associated with a reduced risk of MACE (OR 0.86, 95% CI 0.79–0.95), myocardial infarction (OR 0.76, 95% CI 0.64–0.88) and unstable angina (OR 0.69, 95% CI 0.54–0.88) compared to control, over a median follow up of 87 (15–162) weeks. BA was associated with a reduction of LDL-Cholesterol (mean difference [MD]–22.42,95% CI − 24.02% to − 20.82%), total cholesterol (− 16.50%,95% − 19.21% to − 13.79%), Apo-B lipoprotein (− 19.55%, − 22.68% to − 16.42%) and high-sensitivity CRP (− 27.83%, − 31.71% to − 23.96%) at 12 weeks. BA was associated with a higher risk of gout (OR 1.55, 95% CI 1.27–1.90) as compared with placebo. Efficacy on laboratory endpoints was confirmed, with a variable extent, across patients on statin or ezetimibe background therapy. Conclusions: The improved cholesterol control achieved with BA translates into a reduced risk of MACE, including myocardial infarction and coronary revascularisation. The drug has a satisfactory safety profile except for an increased risk of gout.
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Bempedoic acid lowers LDL cholesterol levels by 15% for those on statins and 24% for those not taking statins.
“Bempedoic acid, a novel LDL cholesterollowering agent acting in the same pathway as statin but without activity in skeletal muscle, which limits the muscle-related adverse effects, lowers LDL cholesterol levels by 15% for those on statins and 24% for those not taking statins (140).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [140]
The Results report an approximately 24% LDL-C reduction without background statins, but reductions with statins varied by intensity: 15.67% with high-intensity statins and 19.58% with moderate- or low-intensity statins. The citing sentence omits that qualification when it says 15% for those on statins. The Introduction supports its description of bempedoic acid’s pathway and lack of activation in skeletal muscle. (LLM, conf=0.90)
Experimental — accuracy not yet measuredBempedoic acid lowers LDL cholesterol levels by 15% for those on statins and 24% for those not taking statins.
“Bempedoic acid, a newer LDL cholesterol–lowering agent targeting the same pathway as statins but without activity in skeletal muscle, thus limiting muscle-related adverse effects, lowers LDL cholesterol levels by 15% for those on statins and 24% for those not taking statins (134).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [134]
The Results (page unavailable) report a 24.13% LDL-C reduction without background statin therapy and a 15.67% reduction with high-intensity statins. They report a 19.58% reduction with moderate- or low-intensity statins, so the citing sentence overgeneralizes the 15% figure to everyone taking statins. The Introduction also supports the description of bempedoic acid’s pathway and limited skeletal-muscle activity. (LLM, conf=0.91)
Experimental — accuracy not yet measuredUse of bempedoic acid with ezetimibe results in an additional 19% reduction in LDL cholesterol.
“Use of this agent with ezetimibe results in an additional 19% reduction in LDL cholesterol (140).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [140]
Use of bempedoic acid with ezetimibe results in an additional 19% reduction in LDL cholesterol.
“Use of this agent with ezetimibe results in an additional 19% reduction in LDL cholesterol (134).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [134]
Bempedoic acid has generally been well tolerated.
“The drug has generally been well tolerated, although an increased risk of gout has been observed [18].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [18]
An increased risk of gout has been observed with bempedoic acid.
“The drug has generally been well tolerated, although an increased risk of gout has been observed [18].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [18]
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- Authors
- De Filippo, O., D’Ascenzo, F., Iannaccone, M., Bertaina, M., Leone, A., Borzillo, I., Ravetti, E., Solano, A., Pagliassotto, I., Nebiolo, M., Bruno, F., Giacobbe, F., Muscoli, S., Monticone, S., Brizzi, M. F., Biondi Zoccai, G., & De Ferrari, G. M.
- Affiliations
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Ospedale San Giovanni Bosco (IT)
- University of Naples Federico II (IT)
- Policlinico Tor Vergata (IT)
- University of Turin (IT)
- Corresponding author
- D’Ascenzo, Fabrizio
- ORCID
- Venue
- Cardiovascular Diabetology
- Published
- 2023-11-28
- Volume
- 22
- Issue
- 1
- Pages
- 324-324
- ISSN
- 1475-2840 (ISSN-L)
- PMC
- PMC10685600
- OpenAlex
- W4389083456
- Cited by
- 43
- References
- 40
- Citations by year
- 2026: 16 · 2025: 19 · 2024: 7 · 2023: 1
- FWCI
- 2.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Cardiovascular Diabetology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- bempedoic acid, hypercholesterolemia, lipid-lowering therapy, LDL cholesterol lowering, major adverse cardiovascular events, myocardial infarction, unstable angina, gout, new-onset diabetes, apolipoprotein B, high-sensitivity CRP, drug safety, drug efficacy
- MeSH terms
- Cholesterol, Dicarboxylic Acids, Fatty Acids, Gout, Humans, Cholesterol, LDL, Myocardial Infarction, Randomized Controlled Trials as Topic, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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