Evidence map›Paper›PMID 37458138›Full record

ArticleCancer medicine2023

Effect of proprotein convertase subtilisin/kexin type 9 inhibition on cancer events: A pooled, post hoc, competing risk analysis of alirocumab clinical trials.

Kusha A Mohammadi, Taylor Brackin, Gregory G Schwartz, Philippe Gabriel Steg, Michael Szarek, Garen Manvelian, Robert Pordy, Sergio Fazio, Gregory P Geba

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
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  4. Review
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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

9 authors at 4 institutions in 2 countries.

Kusha A MohammadiRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Taylor BrackinRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Gregory G SchwartzUniversity of Colorado School of Medicine, Aurora, Colorado, USA.
Philippe Gabriel StegUniversité Paris-Cité, Paris, France.
Michael SzarekState University of New York, Downstate School of Public Health, Brooklyn, New York, USA.
Garen ManvelianRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Robert PordyRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Sergio FazioRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Gregory P GebaRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.ORCID 0000-0001-8936-748X
Regeneron (United States) · USInserm · FRState University of New York · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAssess the risk of new and worsening cancer events among participants who received the lipid-lowering therapy alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor.

designPooled post hoc analysis.

settingSix phase 3 or phase 4 placebo-controlled randomised trials with alirocumab.

participantsA total of 24,070 patients from the safety population with complete dosing data (alirocumab, n = 12,533; placebo, n = 11,537).

interventionAlirocumab 75 mg, alirocumab 150 mg, alirocumab 75 mg increasing to 150 mg if low-density lipoprotein cholesterol <50 mg/dL not achieved, or placebo, all every 2 weeks. All participants received background high-intensity or maximum-tolerated statin therapy. OUTCOMES AND MEASURES: The first new or worsening incident cancer events were assessed during the treatment-emergent adverse event period. Four outcomes were evaluated: any-neoplasm, malignant neoplasms, broad definition of hormone-sensitive cancers, and stricter definition of hormone-sensitive cancers. Sub-distribution hazard ratios and 95% confidence intervals (CIs) were estimated using a competing risk framework, with death as a competing risk.

resultsConsidering both treatment arms in aggregate, 969 (4.03%), 779 (3.24%), 178 (0.74%) and 167 (0.69%) patients developed any neoplasm, malignant neoplasms, broad definition of hormone-sensitive cancer and strict definition of hormone-sensitive cancer events, respectively. There was no significant difference in the risk of having any neoplasm in the alirocumab versus the placebo group (sub-distribution hazards ratio [95% CI], 0.93 [0.82-1.1]; p = 0.28). A nominally lower risk of having any neoplasms with alirocumab was observed among subjects aged ≥64 years (sub-distribution hazards ratio 0.83; 95% CI, 0.70-0.99).

conclusionsIntensive low-density lipoprotein cholesterol lowering with a proprotein convertase subtilisin/kexin type 9 inhibitor combined with statin does not appear to increase the risk of new or worsening cancer events.

Indexed as

Antibodies, MonoclonalNeoplasmsPCSK9 InhibitorsAntibodies, Monoclonal, HumanizedCholesterol, LDLHumansHydroxymethylglutaryl-CoA Reductase InhibitorsRisk AssessmentSubtilisinsTreatment OutcomealirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 InhibitorsSubtilisinsalirocumabcholesterolincident cancerLDL-CPCSK9 inhibitorserum lipids

Identifiers

PMID37458138
PMCPMC10501297
OpenAlexW4384493093

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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 OpenQuestion graph.