Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
Open accessAbstract
BACKGROUND: Bempedoic acid, an ATP citrate lyase inhibitor, reduces low-density lipoprotein (LDL) cholesterol levels and is associated with a low incidence of muscle-related adverse events; its effects on cardiovascular outcomes remain uncertain. METHODS: We conducted a double-blind, randomized, placebo-controlled trial involving patients who were unable or unwilling to take statins owing to unacceptable adverse effects ("statin-intolerant" patients) and had, or were at high risk for, cardiovascular disease. The patients were assigned to receive oral bempedoic acid, 180 mg daily, or placebo. The primary end point was a four-component composite of major adverse cardiovascular events, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. RESULTS: A total of 13,970 patients underwent randomization; 6992 were assigned to the bempedoic acid group and 6978 to the placebo group. The median duration of follow-up was 40.6 months. The mean LDL cholesterol level at baseline was 139.0 mg per deciliter in both groups, and after 6 months, the reduction in the level was greater with bempedoic acid than with placebo by 29.2 mg per deciliter; the observed difference in the percent reductions was 21.1 percentage points in favor of bempedoic acid. The incidence of a primary end-point event was significantly lower with bempedoic acid than with placebo (819 patients [11.7%] vs. 927 [13.3%]; hazard ratio, 0.87; 95% confidence interval [CI], 0.79 to 0.96; P = 0.004), as were the incidences of a composite of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (575 [8.2%] vs. 663 [9.5%]; hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P = 0.006); fatal or nonfatal myocardial infarction (261 [3.7%] vs. 334 [4.8%]; hazard ratio, 0.77; 95% CI, 0.66 to 0.91; P = 0.002); and coronary revascularization (435 [6.2%] vs. 529 [7.6%]; hazard ratio, 0.81; 95% CI, 0.72 to 0.92; P = 0.001). Bempedoic acid had no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, and death from any cause. The incidences of gout and cholelithiasis were higher with bempedoic acid than with placebo (3.1% vs. 2.1% and 2.2% vs. 1.2%, respectively), as were the incidences of small increases in serum creatinine, uric acid, and hepatic-enzyme levels. CONCLUSIONS: Among statin-intolerant patients, treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization). (Funded by Esperion Therapeutics; CLEAR Outcomes ClinicalTrials.gov number, NCT02993406.).
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In CLEAR Outcomes, bempedoic acid compared with placebo in 13,970 patients with established or high risk for CVD, intolerance to statins, and LDL-C level ≥100 mg/dL reduced the risk of MACE by −13% (HR 0.87, 95% CI 0.79-0.96, p = 0.004) and resulted in a −21.1% greater reduction in LDL-C levels.
“The CLEAR Outcomes trial randomized 13,970 patients with established or high risk for CVD, intolerance to statins, and LDL-C level ≥ 100 mg/dL to receive bempedoic acid (180 mg daily) or placebo [131]. Bempedoic acid reduced the risk of MACE by − 13% (HR 0.87, 95% CI 0.79–0.96, p = 0.004) and resulted in a − 21.1% greater reduction in LDL-C levels”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [133]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn CLEAR Outcomes, ∼19% of individuals were on very-low-dose statin therapy at baseline.
“It is important to note that ∼19% of individuals were on very-low-dose statin therapy at baseline (135).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [135]
The Trial Population section says patients taking a very low average daily statin dose could enroll. The Results report that 22.7% of participants were taking a statin at baseline, but do not establish that approximately 19% were taking a very-low-dose statin. (LLM, conf=0.83)
Experimental — accuracy not yet measuredEzetimibe lowers LDL-C by 18-25%, bempedoic acid by 17-21%, and their combination by ∼36-40%.
“This substantially exceeded other oral non-statin therapies, as ezetimibe lowers LDL-C by 18–25%, bempedoic acid by 17–21%, and their combination by ∼36–40% [[21], [22], [23], [24]]”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [23]
The paper’s introductory passage reports LDL-C reductions of 17–28% with bempedoic acid, and ‘Effect on LDL Cholesterol and High-Sensitivity CRP’ reports a 21.1-percentage-point difference versus placebo at six months. Those findings support the bempedoic-acid portion broadly, but the copy does not give the claimed 18–25% reduction for ezetimibe or ∼36–40% for the combination. Page numbers were not provided for these passages. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the CLEAR-Outcomes trial, bempedoic acid's relative risk reduction for the primary composite outcome differed significantly between primary and secondary prevention groups (hazard ratios 0.68 versus 0.91).
“In the CLEAR-Outcomes trial, an intriguing observation was that BA’s relative risk reduction for the primary composite outcome differed significantly between the primary and secondary prevention groups (with hazard ratios of 0.68 versus 0.91 respectively) [7].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [7]
The Discussion (page unavailable) says the hazard ratio for the primary endpoint was lower in the primary-prevention subgroup than in the secondary-prevention group. Our copy does not give the claimed subgroup hazard ratios of 0.68 and 0.91 or establish a statistically significant difference between them; it cautions that subgroup analyses were not adjusted for multiplicity and do not provide definitive conclusions. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn CLEAR Outcomes, a higher frequency of gout (3.1% versus 2.1%) and cholelithiasis (2.2% versus 1.2%) was observed with bempedoic acid than with placebo.
“A higher frequency of gout (3.1% versus 2.1%) and cholelithiasis (2.2% versus 1.2%) was observed with bempedoic acid than with placebo [133].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [133]
The CLEAR Outcomes trial found a reduction in four-point major adverse cardiovascular events by 13% compared with placebo for individuals with established ASCVD (70% of population) or at high risk for ASCVD (30% of population) and considered to be intolerant to statin therapy.
“The Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid or Placebo (CLEAR Outcomes) trial found a reduction in four-point major adverse cardiovascular events by 13% compared with placebo for individuals with established ASCVD (70% of population) or at high risk for ASCVD (30% of population) a”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [141]
The CLEAR Outcomes trial demonstrated a significant reduction in MACE compared with placebo in patients who are statin intolerant.
“Clinical trials have shown bempedoic acid reduces LDL-C levels and the CLEAR Outcomes trial demonstrated a significant reduction in MACE compared with placebo in patients who are statin intolerant [[12], [13], [14], [15],17].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [17]
The CLEAR Outcomes trial reported cardiovascular outcomes in a mixed population of primary and secondary prevention patients unable or unwilling to take guideline-recommended doses of statins.
“The CLEAR Outcomes (Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen) trial reported cardiovascular outcomes in a mixed population of primary and secondary prevention patients unable or unwilling to take guideline-recommended doses of statins.11”
From Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients (2023) · cites this paper as [11]
This primary prevention cohort was a prespecified subgroup that represented 30% of the total enrolled within a larger trial that included a mixed population of primary and secondary prevention patients.
“This primary prevention cohort was a prespecified subgroup that represented 30% of the total enrolled within a larger trial that included a mixed population of primary and secondary prevention patients.11”
From Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients (2023) · cites this paper as [11]
The CLEAR Outcomes trial showed reductions in clinical events with bempedoic acid.
“This was followed by recent data from the CLEAR Outcomes trial showing reductions in clinical events [7].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [7]
Differences between these results and previous meta-analyses are likely attributable to lack of statistical power and imprecise estimates because CLEAR Outcomes had not yet been published at the time of the previous meta-analyses but is included in this meta-analysis.
“These differences are likely attributable to a lack of statistical power and imprecise estimates as the largest outcomes-based trial, CLEAR Outcomes, had not yet been published at the time of the previous meta-analyses but is included in our meta-analysis [7].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [7]
Most included trials had relatively short follow-up durations, except CLEAR Outcomes and CLEAR Harmony.
“Additionally, most of the trials included in this analysis had relatively short follow-up durations with the exception of CLEAR Outcomes [7] and CLEAR Harmony [12].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [7]
Overall risk of bias was low in 7 of 11 included trials and moderate in 4 trials.
“The overall risk of bias was low 7 of 11 trials [7, 9–12, 15, 16], with 4 trials being assessed as having a moderate risk of bias [8, 13, 14, 17].”
From The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials (2024) · cites this paper as [7]
The Trial Organization and Oversight section describes one randomized, placebo-controlled trial, and the Statistical Analysis section describes its analysis. Our copy does not report a risk-of-bias assessment of 11 included trials or classify seven as low risk and four as moderate risk (searched for those counts and for risk-of-bias assessment of included studies). (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn the CLEAR Outcomes study, among the 6992 patients assigned to the active arm, 45% had type 2 diabetes; bempedoic acid was associated with a significantly lower incidence of the four-component composite primary endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization and a higher incidence of some adverse events (gout and cholelithiasis)
“Among the 6992 patients assigned to the active arm of the study 45% had T2DM.Bempedoic acid was associated with a significantly lower incidence of the four-component composite primary endpoint of CV death, non-fatal MI, non-fatal stroke, or coronary revascularization and a higher incidence of some adverse events (gout and cholelithiasis) at the 40.6 month follow-up.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [282]
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- Authors
- Nissen, S. E., Lincoff, A. M., Brennan, D., Ray, K. K., Mason, D., Kastelein, J. J. P., Thompson, P. D., Libby, P., Cho, L., Plutzky, J., Bays, H. E., Moriarty, P. M., Menon, V., Grobbee, D. E., Louie, M. J., Chen, C.-F., Li, N., Bloedon, L., Robinson, P., Horner, M., Sasiela, W. J., McCluskey, J., Davey, D., Fajardo-Campos, P., Petrovic, P., Fedacko, J., Zmuda, W., Lukyanov, Y., & Nicholls, S. J.
- Affiliations
- Brigham and Women's Hospital (US)
- From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) — both in the Netherlands; Hartford Hospital, Hartford, CT (P.D.T.); Brigham and Women’s Hospital, Harvard Medical School, Boston (P.L., J.P.); Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); University of Kansas Medical Center, Kansas City (P.M.M.); Esperion Therapeutics, Ann Arbor, MI (M.J.L., C.-F.C., N.L., L.B., P.R., M.H., W.J.S.); Centro de Investigación Cardiovascular y Metabólica, Tijuana, Mexico (P.F.-C.); General Hospital Sveti Luka, Smederevo, Serbia (P.P.); Center of Clinical and Preclinical Research Medipark, Pavol Jozef Šafárik University, Košice, Slovakia (J.F.); Medicome, Oświęcim, Poland (W.Z.); Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia (Y.L.); and Victorian Heart I...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2023-04-13
- Volume
- 388
- Issue
- 15
- Pages
- 1353-1364
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4323075797
- Semantic Scholar
- 33b876475ba15ddd5ffc66ad5046afe4cb9173b0
- Cited by
- 988
- References
- 21
- Citations by year
- 2026: 266 · 2025: 261 · 2024: 270 · 2023: 189 · 2017: 2
- FWCI
- 263.23
- Type
- journal article
- Language
- en
- Open access
- green
- pure.amsterdamumc.nl
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Esperion Therapeutics
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- bempedoic acid, statin intolerance, ATP-citrate lyase inhibitor, LDL cholesterol lowering, major adverse cardiovascular events, cardiovascular disease prevention, LDL cholesterol targets, cardiovascular mortality, myocardial infarction, stroke, coronary revascularization, hypercholesterolemia, lipid-lowering therapy, statin adverse effects
- MeSH terms
- Administration, Oral, Hypolipidemic Agents, Cardiovascular Diseases, Dicarboxylic Acids, Double-Blind Method, Fatty Acids, Humans, Myocardial Infarction, Myocardial Revascularization, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Stroke
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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