Bempedoic acid

Bempedoic acid is a daily pill that lowers LDL cholesterol. In CLEAR Outcomes, which enrolled people who could not take statins, it lowered a combined set of heart events in statin-intolerant people, but it did not show an effect on death.

Also called Nexletol

Drug
In this atlas

Overview

Technical summary

RxNorm ingredient 2282403. The CLEAR Outcomes abstract describes it as an ATP citrate lyase inhibitor. Outcomes evidence: CLEAR Outcomes (statin-intolerant people only).

About this drug

Level: Substance
Mechanism: ATP citrate lyase inhibitor that reduces LDL cholesterol (CLEAR Outcomes abstract)

Claims and evidence

Context Statin-intolerant adults with or at high risk for cardiovascular disease (CLEAR Outcomes)

Recipient: Adult
Population: Patients unable or unwilling to take statins because of unacceptable adverse effects (statin-intolerant) who had, or were at high risk for, cardiovascular disease (abstract). The registry gives ages 18 to 85 years.
Care setting: Multicentre trial (abstract); site list not read
Geography: Multinational: the study record lists every country the registry names
Life stage: Adult, 18 to 85 years (registry)
Follow-up: Median follow-up 40.6 months (abstract).

Eligibility: 2 inclusion criteria; exclusion criteria not stated

Included: Unable or unwilling to take statins owing to unacceptable adverse effects
Had, or at high risk for, cardiovascular disease
Excluded: None stated

Effect Interventional Certainty not assessed

In CLEAR Outcomes, 13,970 statin-intolerant patients who had, or were at high risk for, cardiovascular disease took bempedoic acid 180 mg daily (6992) or placebo (6978). Over a median of 40.6 months, the four-component primary composite occurred in 819 patients (11.7%) on bempedoic acid and 927 (13.3%) on placebo (hazard ratio 0.87, 95% CI 0.79 to 0.96). The abstract says there were no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, or death from any cause. Gout (3.1% against 2.1%) and cholelithiasis (2.2% against 1.2%) were more common with bempedoic acid, as were small increases in serum creatinine, uric acid and hepatic-enzyme levels.
Applies to Adult
- Patients unable or unwilling to take statins because of unacceptable adverse effects (statin-intolerant) who had, or were at high risk for, cardiovascular disease (abstract). The registry gives ages 18 to 85 years.
- Multicentre trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- Adult, 18 to 85 years (registry)
Follow-up Median follow-up 40.6 months (abstract).
Certainty method
Not assessed

Limitations
One randomised, double-blind trial funded by Esperion Therapeutics according to the abstract. The primary composite includes coronary revascularization, which is a softer end point than death. The result is for statin-intolerant people and does not apply to people who tolerate statins. Abstract only.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (11)
1. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 1: "A total of 13,970 patients underwent randomization; 6992 were assigned to the bempedoic acid group and 6978 to the placebo group."
  
  How it applies
  Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, METHODS, sentence 1, fragment 1 of 2: "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)"
  
  How it applies
  Statin-intolerant population.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, METHODS, sentence 1, fragment 2 of 2: "and had, or were at high risk for, cardiovascular disease."
  
  How it applies
  With, or at high risk for, cardiovascular disease.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, METHODS, sentence 2: "The patients were assigned to receive oral bempedoic acid, 180 mg daily, or placebo."
  
  How it applies
  Dose and comparator.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
5. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 2: "The median duration of follow-up was 40.6 months."
  
  How it applies
  Median follow-up.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
6. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 4, fragment 1 of 5: "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,"
  
  How it applies
  Primary end point counts.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
7. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 4, fragment 2 of 5: "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,"
  
  How it applies
  Primary end point counts and hazard ratio.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
8. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 5: "Bempedoic acid had no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, and death from any cause."
  
  How it applies
  Stroke and death results, as reported.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
9. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 6, fragment 1 of 2: "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),"
  
  How it applies
  Gout and cholelithiasis.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
10. Supports Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, RESULTS, sentence 6, fragment 2 of 2: "as were the incidences of small increases in serum creatinine, uric acid, and hepatic-enzyme levels."
  
  How it applies
  Laboratory changes.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
11. Background Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2023-04-13 · DOI: 10.1056/NEJMoa2215024 · PMID: 36876740
  
  Locator
  Abstract, CONCLUSIONS, sentence 2: "(Funded by Esperion Therapeutics; CLEAR Outcomes ClinicalTrials.gov number, NCT02993406.)."
  
  How it applies
  Funding note in the abstract.
  
  Retrieved
  2026-10-14T18:18:35Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  eb061946988abbdd8b8981c59570bfa5922d46a4046867ca220ccf6623009af5
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Fewer major cardiovascular events in statin-intolerant people: High LDL cholesterol (Evaluated for)
Applies to Adult
- Patients unable or unwilling to take statins because of unacceptable adverse effects (statin-intolerant) who had, or were at high risk for, cardiovascular disease (abstract). The registry gives ages 18 to 85 years.
- Multicentre trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- Adult, 18 to 85 years (registry)
Follow-up Median follow-up 40.6 months (abstract).
In CLEAR Outcomes, 13,970 statin-intolerant patients who had, or were at high risk for, cardiovascular disease took bempedoic acid 180 mg daily (6992) or placebo (6978). Over a median of 40.6 months, the four-component primary composite occurred in 819 patients (11.7%) on bempedoic acid and 927 (13.3%) on placebo (hazard ratio 0.87, 95% CI 0.79 to 0.96). The abstract says there were no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, or death from any cause. Gout (3.1% against 2.1%) and cholelithiasis (2.2% against 1.2%) were more common with bempedoic acid, as were small increases in serum creatinine, uric acid and hepatic-enzyme levels.
Limitations. One randomised, double-blind trial funded by Esperion Therapeutics according to the abstract. The primary composite includes coronary revascularization, which is a softer end point than death. The result is for statin-intolerant people and does not apply to people who tolerate statins. Abstract only.

Record details

Record id: cardio:bempedoic-acid
Content hash: f1710e1cafdbfc8beea3064794dd7e3a046472caf054b4df9a5b937d2d111e7f