Alirocumab

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.

Also called Praluent

Drug
In this atlas

Overview

Technical summary

RxNorm ingredient 1659152. Human monoclonal antibody to PCSK9 per the FDA label of Praluent (BLA125559), which is the source of the target link. A page for the branded product can be added later.

About this drug

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

Claims and evidence

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).

Eligibility: 3 inclusion criteria; exclusion criteria not stated

Included: Acute coronary syndrome 1 to 12 months earlier
LDL cholesterol at least 70 mg/dL, or non-HDL cholesterol at least 100 mg/dL, or apolipoprotein B at least 80 mg/dL
High-intensity statin or maximum tolerated dose
Excluded: None stated

Effect Interventional Certainty not assessed

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).
Applies to Adult
- 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.
- Multicentre trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- Adult, 40 years and older (registry minimum age)
Follow-up Median follow-up 2.8 years (abstract).
Certainty method
Not assessed

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

Next evidence check due
Not scheduled
Sources and citations (15)
1. Supports Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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,"
  
  How it applies
  Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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."
  
  How it applies
  Statin background.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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."
  
  How it applies
  Dose and schedule of alirocumab and placebo.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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,"
  
  How it applies
  Primary end point, first part.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  Locator
  Abstract, METHODS, sentence 4, fragment 2 of 2: "or unstable angina requiring hospitalization."
  
  How it applies
  Primary end point, last part.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  Locator
  Abstract, RESULTS, sentence 1: "The median duration of follow-up was 2.8 years."
  
  How it applies
  Median follow-up.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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%)"
  
  How it applies
  Primary end point counts.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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)."
  
  How it applies
  Primary end point hazard ratio.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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,"
  
  How it applies
  Deaths, counts and hazard ratio.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  Locator
  Abstract, RESULTS, sentence 3, fragment 2 of 2: "0.73 to 0.98)."
  
  How it applies
  Deaths, interval.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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"
  
  How it applies
  Baseline LDL subgroup.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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."
  
  How it applies
  Baseline LDL subgroup, threshold.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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. Supports Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  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."
  
  How it applies
  Adverse events.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  Locator
  Abstract, RESULTS, sentence 5, fragment 2 of 2: "2.1% in the placebo group)."
  
  How it applies
  Injection-site reactions, placebo.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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.
15. Background Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
  
  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 2018-11-29 · DOI: 10.1056/NEJMoa1801174 · PMID: 30403574
  
  Locator
  Abstract, CONCLUSIONS, sentence 2: "(Funded by Sanofi and Regeneron Pharmaceuticals; ODYSSEY OUTCOMES ClinicalTrials.gov number, NCT01663402 .)."
  
  How it applies
  Funding note in the abstract.
  
  Retrieved
  2026-10-14T18:18:34Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  9e2c9d0adf253dc689cbf8a36caaf42917565582fe941874a0e1b65733c11079
  
  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 events after acute coronary syndrome: Coronary artery disease (Evaluated for)
Applies to Adult
- 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.
- Multicentre trial (abstract); site list not read
- Multinational: the study record lists every country the registry names
- 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).
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.

Record details

Record id: cardio:alirocumab
Content hash: a4fa34d6bccadf64fcb9873b673cb5b90dc75c9376fb64999ee3c176f107bfa3