Evolocumab

Evolocumab is an antibody, given by injection, that blocks the PCSK9 protein and lowers LDL cholesterol by about 60% in the FOURIER abstract. In FOURIER it reduced heart and blood-vessel events in people with cardiovascular disease who already took a statin.

Also called AMG 145

Drug
In this atlas

Overview

Technical summary

RxNorm ingredient 1665684. Human monoclonal IgG2 directed against PCSK9 per the FDA label. Brand product: Repatha. Outcomes evidence: FOURIER.

About this drug

Level: Substance
Mechanism: Monoclonal antibody that inhibits PCSK9, so more LDL receptors are available to clear LDL from the blood (FDA label)

Claims and evidence

Context Adults aged 40 to 85 with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL or higher on statin therapy (FOURIER)

Recipient: Adult
Population: Patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy (abstract). The registry gives ages 40 to 85 years and all sexes.
Care setting: Multicentre outpatient trial (abstract); site list not read
Geography: Multinational: the study record lists every country the registry names
Life stage: Adult, 40 to 85 years (registry)
Follow-up: Median follow-up 2.2 years (abstract).

Eligibility: 2 inclusion criteria; exclusion criteria not stated

Included: Atherosclerotic cardiovascular disease
LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher on statin therapy (abstract)
Excluded: None stated

Effect Interventional Certainty not assessed

In FOURIER, 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL or higher on statin therapy received evolocumab or placebo by injection. At 48 weeks the LDL cholesterol was 59% lower with evolocumab than with placebo, to a median of 30 mg/dL. The primary composite end point occurred in 1344 patients (9.8%) on evolocumab and 1563 (11.3%) on placebo (hazard ratio 0.85, 95% CI 0.79 to 0.92). The key secondary composite occurred in 816 (5.9%) and 1013 (7.4%) (hazard ratio 0.80, 95% CI 0.73 to 0.88). The abstract reports no significant difference in adverse events except injection-site reactions, more common with evolocumab (2.1% against 1.6%).
Applies to Adult
- Patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy (abstract). The registry gives ages 40 to 85 years and all sexes.
- Multicentre outpatient trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- Adult, 40 to 85 years (registry)
Follow-up Median follow-up 2.2 years (abstract).
Certainty method
Not assessed

Limitations
One randomised, double-blind, placebo-controlled trial with a median follow-up of 2.2 years, funded by Amgen according to the abstract. The population is defined by atherosclerotic cardiovascular disease, which is wider than coronary artery disease. Abstract only.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (13)
1. Supports Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, METHODS, sentence 1, fragment 1 of 2: "We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8"
  
  How it applies
  Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, METHODS, sentence 1, fragment 2 of 2: "mmol per liter) or higher who were receiving statin therapy."
  
  How it applies
  Statin background.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, METHODS, sentence 3: "The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization."
  
  How it applies
  Primary end point.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, METHODS, sentence 4: "The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke."
  
  How it applies
  Key secondary end point.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, METHODS, sentence 5: "The median duration of follow-up was 2.2 years."
  
  How it applies
  Median follow-up.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 1, fragment 1 of 2: "At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%,"
  
  How it applies
  LDL cholesterol reduction at 48 weeks.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 1, fragment 2 of 2: "from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001)."
  
  How it applies
  Baseline and achieved median LDL cholesterol.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 1 of 3: "Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85;"
  
  How it applies
  Primary end point counts and hazard ratio.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 2 of 3: "95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI,"
  
  How it applies
  Key secondary end point counts.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 3 of 3: "0.73 to 0.88; P<0.001)."
  
  How it applies
  Key secondary hazard ratio interval.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 4, fragment 1 of 2: "There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events),"
  
  How it applies
  Adverse events.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, RESULTS, sentence 4, fragment 2 of 2: "with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%)."
  
  How it applies
  Injection-site reactions.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
  
  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 2017-05-04 · DOI: 10.1056/NEJMoa1615664 · PMID: 28304224
  
  Locator
  Abstract, CONCLUSIONS, sentence 3: "(Funded by Amgen; FOURIER ClinicalTrials.gov number, NCT01764633 .)."
  
  How it applies
  Funding note in the abstract.
  
  Retrieved
  2026-10-14T18:18:33Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48
  
  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 on top of a statin: Coronary artery disease (Evaluated for)
Applies to Adult
- Patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy (abstract). The registry gives ages 40 to 85 years and all sexes.
- Multicentre outpatient trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- Adult, 40 to 85 years (registry)
Follow-up Median follow-up 2.2 years (abstract).
In FOURIER, 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL or higher on statin therapy received evolocumab or placebo by injection. At 48 weeks the LDL cholesterol was 59% lower with evolocumab than with placebo, to a median of 30 mg/dL. The primary composite end point occurred in 1344 patients (9.8%) on evolocumab and 1563 (11.3%) on placebo (hazard ratio 0.85, 95% CI 0.79 to 0.92). The key secondary composite occurred in 816 (5.9%) and 1013 (7.4%) (hazard ratio 0.80, 95% CI 0.73 to 0.88). The abstract reports no significant difference in adverse events except injection-site reactions, more common with evolocumab (2.1% against 1.6%).
Limitations. One randomised, double-blind, placebo-controlled trial with a median follow-up of 2.2 years, funded by Amgen according to the abstract. The population is defined by atherosclerotic cardiovascular disease, which is wider than coronary artery disease. Abstract only.

Record details

Record id: cardio:evolocumab
Content hash: 8be8476574c347343f4c03322737922d85716f2a2e16bbad4ea8a3a7201f55d1