# Evolocumab Drug · id `cardio:evolocumab` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: AMG 145 Browse, condition area: Coronary and vascular disease ## In plain language 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. ## Technical summary RxNorm ingredient 1665684. Human monoclonal IgG2 directed against PCSK9 per the US drug label. Brand product: Repatha. Outcomes evidence: FOURIER. ## Claims, with the population each applies to ## 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). ### 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%). - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - 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 - Sources: 1. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Abstract of the paper from PubMed; the full text was not read. 2. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, METHODS, sentence 1, fragment 2 of 2: "mmol per liter) or higher who were receiving statin therapy.". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Statin background. 3. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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.". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Primary end point. 4. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, METHODS, sentence 4: "The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke.". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Key secondary end point. 5. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, METHODS, sentence 5: "The median duration of follow-up was 2.2 years.". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Median follow-up. 6. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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%,". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: LDL cholesterol reduction at 48 weeks. 7. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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).". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Baseline and achieved median LDL cholesterol. 8. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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;". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Primary end point counts and hazard ratio. 9. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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,". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Key secondary end point counts. 10. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentence 2, fragment 3 of 3: "0.73 to 0.88; P<0.001).". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Key secondary hazard ratio interval. 11. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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),". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Adverse events. 12. Supports: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) 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%).". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Injection-site reactions. 13. Background: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, CONCLUSIONS, sentence 3: "(Funded by Amgen; FOURIER ClinicalTrials.gov number, NCT01764633 .).". Retrieved 2026-10-14T18:18:33Z. Source state: Current. Snapshot hash: c3ef00520132a1d8f7d900daf5951bc679007161222b6d308b59048d85116c48. How it applies: Funding note in the abstract. ## Connected pages - Fewer major cardiovascular events on top of a statin: Coronary artery disease (`cardio:coronary-artery-disease`) [a claim, not a settled fact; see claim `cardio:claim-fourier-evolocumab-cardiovascular-events` and its context] - Binds PCSK9: PCSK9 (gene and protein) (`cardio:pcsk9`) - Files under this front: Medicines (`cardio:front-medicines`) - Contained in: Evolocumab (Repatha) (`cardio:repatha`) - Investigated in: FOURIER (evolocumab in people with cardiovascular disease) (`cardio:fourier`) ## Provenance Content hash: fb1d96d60146d1b181530606902580ee67a69db863c2cbcae5f7d9d6dec066e7 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-14