Evidence map›Paper›PMID 27737744›Full record

Trial reportJournal of the American College of Cardiology2016

Arterial Effects of Canakinumab in Patients With Atherosclerosis and Type 2 Diabetes or Glucose Intolerance.

Robin P Choudhury, Jacqueline S Birks, Venkatesh Mani, Luca Biasiolli, Matthew D Robson, Philippe L L'Allier, Marc-Alexandre Gingras, Nadia Alie, Mary Ann McLaughlin, Craig T Basson and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00995930 (A Multi-center, Randomized , Double Blind, Placebo-controlled, Study of the Safety, Tolerability, and Effects on Arterial Structure and Function of ACZ885 in Patients With Clinically Evident Atherosclerosis and Either T2DM or IGT), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT00995930 phase2completednot on this map

A Multi-center, Randomized , Double Blind, Placebo-controlled, Study of the Safety, Tolerability, and Effects on Arterial Structure and Function of ACZ885 in Patients With Clinically Evident Atherosclerosis and Either T2DM or IGT

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2014Enrolled189ConditionsDiabetes Mellitus, Type 2, Atherosclerosis, Prediabetic StateArmsACZ885, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 89 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 3 countries.

Robin P ChoudhuryOxford Acute Vascular Imaging Centre, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: robin.choudhury@cardiov.ox.ac.uk.
Jacqueline S BirksCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford, United Kingdom.
Venkatesh ManiTranslational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Luca BiasiolliOxford Acute Vascular Imaging Centre, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
Matthew D RobsonOxford Acute Vascular Imaging Centre, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
Philippe L L'AllierMontreal Heart Institute, Université de Montréal, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, Canada.
Marc-Alexandre GingrasMontreal Heart Institute, Université de Montréal, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, Canada.
Nadia AlieNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Mary Ann McLaughlinTranslational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Craig T BassonNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Alison D SchecterNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Eric C SvenssonNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Yiming ZhangNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Denise YatesNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Jean-Claude TardifMontreal Heart Institute, Université de Montréal, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, Canada.
Zahi A FayadTranslational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: zahi.fayad@mssm.edu.
Novartis (United States) · USUniversity of Oxford · GBIcahn School of Medicine at Mount Sinai · USMontreal Heart Institute · CABoston Biomedical Research Institute · US

Funding

Wellcome TrustWellcome Trust 088291/Z/09/Z
6 · The paper itself

Abstract

backgroundEvidence suggests that interleukin (IL)-1β is important in the pathogenesis of atherosclerosis and its complications and that inhibiting IL-1β may favorably affect vascular disease progression.

objectivesThe goal of this study was to evaluate the effects of IL-1β inhibition with canakinumab versus placebo on arterial structure and function, determined by magnetic resonance imaging.

methodsPatients (N = 189) with atherosclerotic disease and either type 2 diabetes mellitus or impaired glucose tolerance were randomized to receive placebo (n = 94) or canakinumab 150 mg monthly (n = 95) for 12 months. They underwent magnetic resonance imaging of the carotid arteries and aorta.

resultsThere were no statistically significant differences between canakinumab compared with placebo in the primary efficacy and safety endpoints. There was no statistically significant change in mean carotid wall area and no effect on aortic distensibility, measured at 3 separate anatomic sites. The change in mean carotid artery wall area was -3.37 mm

conclusionsThere were no statistically significant effects of canakinumab on measures of vascular structure or function. Canakinumab reduced markers of inflammation (high-sensitivity C-reactive protein and interleukin-6), and there were modest increases in levels of total cholesterol and triglycerides. (Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients; NCT00995930).

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedArteriesAtherosclerosisDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucose IntoleranceHumansInterleukin-1betaMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedcanakinumabInterleukin-1betaC-reactive proteinhomeostasis model assessmentinflammationinterleukin-1

Identifiers

PMID27737744
PMCPMC5064025
OpenAlexW2531064413

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.