Evidence map›Paper›PMID 40847481›Full record

Trial reportJournal of the American Heart Association2025

Effect of PCSK9 Inhibition With Alirocumab in Patients With Probable Familial Hypercholesterolemia or Type III Hyperlipoproteinemia: Results From the ODYSSEY OUTCOMES Trial.

Gregory P Geba, Kusha A Mohammadi, Amy Damask, Charles Paulding, Luca A Lotta, George Hindy, Robert Pordy, Garen Manvelian, Michael D Shapiro, Vera A Bittner and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01663402. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01663402 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Ran2012Enrolled18,924Registered outcomes15Posted comparisons6ConditionsAtherosclerotic Cardiovascular DiseaseArmsAlirocumab, LMT, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Familial Hypercholesterolemia.Methodist DeBakey cardiovascular journal · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Gregory P GebaRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.
Kusha A MohammadiRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0002-7844-7537
Amy DamaskRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0003-4995-908X
Charles PauldingRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0002-7918-3561
Luca A LottaRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.
George HindyRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.
Robert PordyRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0002-8001-6795
Garen ManvelianRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0002-5491-1032
Michael D ShapiroSection of Cardiovascular Medicine, Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC USA.ORCID 0000-0002-9071-3287
Vera A BittnerDivision of Cardiovascular Disease University of Alabama at Birmingham Birmingham AL USA.ORCID 0000-0001-9456-850X
Deepak L BhattMount Sinai Fuster Heart Hospital Icahn School of Medicine at Mount Sinai New York NY USA.ORCID 0000-0002-1278-6245
Michael SzarekCPC Clinical Research and Division of Cardiology University of Colorado School of Medicine Aurora CO USA.ORCID 0000-0002-0046-0264
Gregory G SchwartzDivision of Cardiology University of Colorado School of Medicine Aurora CO USA.ORCID 0000-0003-2954-0695
Ph Gabriel StegDepartment of Cardiology Université Paris-Cité, Institut Universitaire de France, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), and INSERM U1148 Paris France.ORCID 0000-0001-6896-2941
Sergio FazioRegeneron Pharmaceuticals, Inc. Tarrytown NY USA.ORCID 0000-0002-8145-8034

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this post hoc analysis of the ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, we evaluated the efficacy of alirocumab in patients with probable heterozygous familial hypercholesterolemia (HeFH) or type III hyperlipoproteinemia (T3HLP).

methodsPatients had clinical HeFH if baseline low-density lipoprotein cholesterol was ≥250 mg/dL and the qualifying acute coronary syndrome event occurred before age 55 (men) or 60 years (women), or if baseline low-density lipoprotein cholesterol was ≥330 mg/dL. Patients had T3HLP if the ratio, validated using the UK Biobank database, of non-high-density lipoprotein cholesterol/apolipoprotein B was >2.6. Genetic variation affecting low-density lipoprotein cholesterol levels (HeFH) and

resultsIn total, 5.8% of patients from ODYSSEY OUTCOMES and 5.9% from the pharmacogenomics subgroup qualified as having clinical HeFH. In the pharmacogenomics subgroup, 295 patients (2.5%) had genetically confirmed HeFH; 45.8% also qualified as having clinical HeFH. Lipid responses and clinical benefits of alirocumab were similar in all patients with or without HeFH. In the ODYSSEY OUTCOMES cohort, 30 of 18 924 patients (0.16%) were identified as having T3HLP. The pharmacogenomics subgroup included 13 of these 30 patients, of whom 7 (53.8%) were

conclusionsIn ODYSSEY OUTCOMES, individuals with HeFH were common while those with T3HLP were rare. In their lipid responses, carriers of both conditions benefited from alirocumab. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT01663402.

Indexed as

Acute Coronary SyndromeAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsHyperlipoproteinemia Type IIHyperlipoproteinemia Type IIIPCSK9 InhibitorsSerine Proteinase InhibitorsAgedApolipoproteins EBiomarkersCholesterol, LDLFemaleHeterozygoteHumansMaleMiddle AgedalirocumabAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsApolipoproteins EBiomarkersCholesterol, LDLPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9Serine Proteinase Inhibitorsalirocumabheterozygous familial hypercholesterolemiaLDL‐Ctype III hyperlipoproteinemia

Identifiers

PMID40847481
PMCPMC12553435

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.