# Alirocumab Drug · id `cardio:alirocumab` · 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: Praluent Browse, condition area: Coronary and vascular disease ## In plain language Alirocumab is an antibody, given by injection, that blocks the PCSK9 protein and lowers LDL cholesterol. In ODYSSEY OUTCOMES it lowered the rate of further heart and blood-vessel events in people after an acute coronary syndrome who took a strong statin. ## Technical summary RxNorm ingredient 1659152. Human monoclonal antibody to PCSK9 per the US drug label of Praluent (BLA125559), which is the source of the target link. A page for the branded product can be added later. ## Claims, with the population each applies to ## Context: Adults 1 to 12 months after an acute coronary syndrome on high-intensity or maximum tolerated statin with raised atherogenic lipids (ODYSSEY OUTCOMES) Recipient: Adult; Population: Patients who had an acute coronary syndrome 1 to 12 months earlier, with LDL cholesterol of at least 70 mg/dL, non-HDL cholesterol of at least 100 mg/dL or apolipoprotein B of at least 80 mg/dL, receiving statin at a high-intensity dose or the maximum tolerated dose (abstract). The registry gives a minimum age of 40 years.; Care setting: Multicentre trial (abstract); site list not read; Geography: Multinational: the study record lists every country the registry names; Life stage: Adult, 40 years and older (registry minimum age); Follow-up: Median follow-up 2.8 years (abstract). ### In ODYSSEY OUTCOMES, 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier and were on high-intensity or maximum tolerated statin received alirocumab or placebo every 2 weeks. Over a median of 2.8 years, the primary composite end point occurred in 903 patients (9.5%) on alirocumab and 1052 (11.1%) on placebo (hazard ratio 0.85, 95% CI 0.78 to 0.93). Death occurred in 334 patients (3.5%) on alirocumab and 392 (4.1%) on placebo (hazard ratio 0.85, 95% CI 0.73 to 0.98). The abstract reports similar adverse events except local injection-site reactions (3.8% on alirocumab, 2.1% on placebo). - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: Recipient: Adult; Population: Patients who had an acute coronary syndrome 1 to 12 months earlier, with LDL cholesterol of at least 70 mg/dL, non-HDL cholesterol of at least 100 mg/dL or apolipoprotein B of at least 80 mg/dL, receiving statin at a high-intensity dose or the maximum tolerated dose (abstract). The registry gives a minimum age of 40 years.; Care setting: Multicentre trial (abstract); site list not read; Geography: Multinational: the study record lists every country the registry names; Life stage: Adult, 40 years and older (registry minimum age); Follow-up: Median follow-up 2.8 years (abstract). - Limitations: One randomised, double-blind trial funded by Sanofi and Regeneron according to the abstract. The abstract reports the death result as a secondary finding without saying how it was tested; this record does not claim a survival benefit beyond the numbers given. The abstract says the absolute benefit was greater in patients with baseline LDL cholesterol of 100 mg/dL or more. Abstract only. - Last checked: 2026-10-14 - Sources: 1. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 5: "We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier,". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Abstract of the paper from PubMed; the full text was not read. 2. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 5 of 5: "and were receiving statin therapy at a high-intensity dose or at the maximum tolerated dose.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Statin background. 3. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 2: "Patients were randomly assigned to receive alirocumab subcutaneously at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Dose and schedule of alirocumab and placebo. 4. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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, fragment 1 of 2: "The primary end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke,". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Primary end point, first part. 5. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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, fragment 2 of 2: "or unstable angina requiring hospitalization.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Primary end point, last part. 6. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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: "The median duration of follow-up was 2.8 years.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Median follow-up. 7. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 2: "A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%)". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Primary end point counts. 8. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 2: "in the placebo group (hazard ratio, 0.85; 95% confidence interval \[CI\], 0.78 to 0.93; P<0.001).". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Primary end point hazard ratio. 9. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 3, fragment 1 of 2: "A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI,". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Deaths, counts and hazard ratio. 10. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 3, fragment 2 of 2: "0.73 to 0.98).". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Deaths, interval. 11. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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: "The absolute benefit of alirocumab with respect to the composite primary end point was greater among patients who had a baseline LDL cholesterol level". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Baseline LDL subgroup. 12. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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: "of 100 mg or more per deciliter than among patients who had a lower baseline level.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Baseline LDL subgroup, threshold. 13. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 5, fragment 1 of 2: "The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs.". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Adverse events. 14. Supports: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 5, fragment 2 of 2: "2.1% in the placebo group).". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Injection-site reactions, placebo. 15. Background: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (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 2: "(Funded by Sanofi and Regeneron Pharmaceuticals; ODYSSEY OUTCOMES ClinicalTrials.gov number, NCT01663402 .).". Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079. How it applies: Funding note in the abstract. ## Connected pages - Fewer events after acute coronary syndrome: Coronary artery disease (`cardio:coronary-artery-disease`) [a claim, not a settled fact; see claim `cardio:claim-odyssey-alirocumab-after-acs` and its context] - Binds PCSK9: PCSK9 (gene and protein) (`cardio:pcsk9`) - Files under this front: Medicines (`cardio:front-medicines`) - Investigated in: ODYSSEY OUTCOMES (alirocumab after acute coronary syndrome) (`cardio:odyssey-outcomes`) ## Provenance Content hash: da8c21e47675583770b286a8e43fd95c80f56fed5e2f8b9180bb4facea6e0bbf Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-14