Ezetimibe

Ezetimibe is a cholesterol pill that is not a statin. It works by reducing how much cholesterol the gut absorbs. In IMPROVE-IT, adding it to a statin after an acute coronary syndrome lowered LDL cholesterol further and gave a small extra reduction in heart and blood-vessel events.

Also called Zetia

  • Drug
  • In this atlas

Overview

Technical summary

RxNorm ingredient 341248. The IMPROVE-IT abstract describes it as a nonstatin drug that reduces intestinal cholesterol absorption. The evidence recorded is the combination with simvastatin; ezetimibe alone is not tested in this atlas.

About this drug

Level
Substance
Mechanism
Reduces intestinal cholesterol absorption (IMPROVE-IT abstract)

Claims and evidence

Context Adults hospitalised for an acute coronary syndrome in the previous 10 days with LDL cholesterol 50 to 100 mg/dL on lipid-lowering therapy (IMPROVE-IT)

Recipient
Adult
Population
Patients hospitalised for an acute coronary syndrome within the preceding 10 days, with LDL cholesterol 50 to 100 mg/dL if on lipid-lowering therapy or 50 to 125 mg/dL if not (abstract). The registry gives a minimum age of 18 years and all sexes.
Care setting
Hospital-recruited patients followed in a multicentre trial (abstract). Site list not read.
Geography
Not stated in the source (abstract). The registry record lists no countries.
Life stage
Adult, 18 years and older (registry minimum age)
Follow-up
Median follow-up 6 years (abstract). The registry gives up to approximately 9 years as the outcome time frame.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Hospitalised for an acute coronary syndrome in the preceding 10 days
  • LDL cholesterol 50 to 100 mg per deciliter if receiving lipid-lowering therapy, or 50 to 125 mg per deciliter if not (abstract)
Excluded
None stated
  • Effect Interventional Certainty not assessed

    In IMPROVE-IT, 18,144 patients hospitalised for an acute coronary syndrome in the previous 10 days received simvastatin 40 mg with ezetimibe 10 mg or simvastatin 40 mg with placebo. The median time-weighted LDL cholesterol was 53.7 mg/dL with ezetimibe added and 69.5 mg/dL with simvastatin alone. At 7 years the Kaplan-Meier rate of the primary composite end point was 32.7% with ezetimibe and 34.7% with simvastatin alone (absolute difference 2.0 percentage points; hazard ratio 0.936, 95% CI 0.89 to 0.99; P=0.016). The abstract says muscle, gallbladder and hepatic adverse effects and cancer were similar in the two groups.

    Applies to Adult
    • Patients hospitalised for an acute coronary syndrome within the preceding 10 days, with LDL cholesterol 50 to 100 mg/dL if on lipid-lowering therapy or 50 to 125 mg/dL if not (abstract). The registry gives a minimum age of 18 years and all sexes.
    • Hospital-recruited patients followed in a multicentre trial (abstract). Site list not read.
    • Not stated in the source (abstract). The registry record lists no countries.
    • Adult, 18 years and older (registry minimum age)
    Follow-up Median follow-up 6 years (abstract). The registry gives up to approximately 9 years as the outcome time frame.
    Certainty method
    Not assessed
    Limitations
    One randomised trial, double-blind, funded by Merck according to the abstract. The benefit is modest in absolute terms (2.0 percentage points at 7 years). The population was people after an acute coronary syndrome who took simvastatin 40 mg; the result is for adding ezetimibe to that statin, not for ezetimibe alone. Abstract only; the registry record lists Organon and Co as its current lead sponsor.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (14)
    1. Supports Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 1, fragment 1 of 4: "We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and"
      How it applies
      Abstract of the paper from PubMed; the full text was not read.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 1, fragment 2 of 4: "had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter)"
      How it applies
      LDL entry range on lipid-lowering therapy.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 1, fragment 3 of 4: "if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter)"
      How it applies
      LDL entry range when not on lipid-lowering therapy.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 2: "The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy)."
      How it applies
      The two treatment arms.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 3, fragment 1 of 2: "The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization),"
      How it applies
      Primary end point, first part.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 3, fragment 2 of 2: "or nonfatal stroke."
      How it applies
      Primary end point, last part.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, METHODS, sentence 4: "The median follow-up was 6 years."
      How it applies
      Median follow-up.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, RESULTS, sentence 1, fragment 1 of 2: "The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group,"
      How it applies
      Time-weighted LDL cholesterol, ezetimibe arm.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, RESULTS, sentence 1, fragment 2 of 2: "as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001)."
      How it applies
      Time-weighted LDL cholesterol, simvastatin-alone arm.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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 Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, RESULTS, sentence 2, fragment 1 of 2: "The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group,"
      How it applies
      Kaplan-Meier event rate at 7 years, ezetimibe arm.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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. Supports Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, RESULTS, sentence 2, fragment 2 of 2: "as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016)."
      How it applies
      Event rate, comparator arm, and hazard ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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.
    12. Supports Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, RESULTS, sentence 3: "Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups."
      How it applies
      Adverse effects and cancer were similar.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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.
    13. Background Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

      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 2015-06-18 · DOI: 10.1056/NEJMoa1410489 · PMID: 26039521

      Locator
      Abstract, CONCLUSIONS, sentence 3: "(Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.)."
      How it applies
      Funding note in the abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      95ed7a7bcbbe090b707e2d1472e160f007bde63f724c65c03b53fb9cbcb93d57
      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.
    14. Supports IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-06-18. · NCT: NCT00202878

      Locator
      protocolSection.designModule.enrollmentInfo.count: "18144"
      How it applies
      Registry enrollment count, equal to the abstract.
      Retrieved
      Source effective date
      2024-06-18
      Source state
      Current
      Snapshot hash
      591576a2ffb6fc2d9789d27fc116ad9587258642700ce74649121e0d84936c81
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/cg-ctgov-NCT00202878.json.

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.

Record details

Record id
cardio:ezetimibe
Content hash
3ebc25dddaa588e0a0b4f5eb7df4e71b858427850ebdb5b02086433c2a338065