Evidence map›Paper›PMID 27705888›Full record

Trial reportEuropean heart journal2017

Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT).

Thomas M MacDonald, Chris J Hawkey, Ian Ford, John J V McMurray, James M Scheiman, Jesper Hallas, Evelyn Findlay, Diederick E Grobbee, F D Richard Hobbs, Stuart H Ralston and 11 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00447759 (Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
11.6field-weighted citation impact, top 1% 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.

NCT00447759 phase4completednot on this map

Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's

TypeinterventionalSponsorUniversity of DundeeRan2007 to 2015Enrolled7,297ConditionsOsteoarthritis, Rheumatoid ArthritisArmsCelecoxib, Diclofenac
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.

  1. Pooled it
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  10. Prostanoids in Cardiac and Vascular Remodeling.Arteriosclerosis, thrombosis, and vascular biology · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 10 institutions in 3 countries.

Thomas M MacDonaldMedicines Monitoring Unit (MEMO), Division of Molecular & Clinical Medicine, University of Dundee, Ninewells Hospital & Medical School Dundee, Dundee DD1 9SY, UK.
Chris J HawkeyFaculty of Medicine & Health Sciences, University of Nottingham, Queen's Medical Centre Nottingham, Nottingham NG7 2UH, UK.
Ian FordRobertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ, UK.
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow,126 University Place, GlasgowG12 8TA, UK.
James M ScheimanDivision of Gastroenterology, University of Michigan Medical School, 1500 E Medical Center Drive, Ann Arbor, MI 48109, USA.
Jesper HallasDepartment of Public Health, Clinical Pharmacology, University of Southern Denmark, J. B. Winsløws Vej 19, 2.5000 Odense, Denmark.
Evelyn FindlayMedicines Monitoring Unit (MEMO), Division of Molecular & Clinical Medicine, University of Dundee, Ninewells Hospital & Medical School Dundee, Dundee DD1 9SY, UK.
Diederick E GrobbeeJulius Center for Health Sciences and Primary Care and Julius Clinical Academic Research Organization, Utrecht, The Netherlands.
F D Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.
Stuart H RalstonCentre for Genomic and Experimental Medicine, Institute of Genetics and Molecular Medicine, University of Edinburgh, Western General Hospital Edinburgh, Edinburgh EH4 2XU, UK.
David M ReidSchool of Medicine & Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
Matthew R WaltersBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow,126 University Place, GlasgowG12 8TA, UK.
John WebsterSchool of Medicine & Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
Frank RuschitzkaDepartment of Cardiology, University Heart Center, Rämistrasse 100, 8091Zürich, Switzerland.
Lewis D RitchieCentre of Academic Primary Care, School of Medicine and Dentistry, University of Aberdeen, AberdeenAB25 2ZD, UK.
Susana Perez-GutthannRTI Health Solutions, Trav. Gracia 56, Atico 1, Barcelona 08006, Spain.
Eugene ConnollyBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow,126 University Place, GlasgowG12 8TA, UK.
Nicola GreenlawRobertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ, UK.
Adam WilsonMedicines Monitoring Unit (MEMO), Division of Molecular & Clinical Medicine, University of Dundee, Ninewells Hospital & Medical School Dundee, Dundee DD1 9SY, UK.
Li WeiDepartment of Practice and Policy, University College London, London WC1H 9JP, UK.
Isla S MackenzieMedicines Monitoring Unit (MEMO), Division of Molecular & Clinical Medicine, University of Dundee, Ninewells Hospital & Medical School Dundee, Dundee DD1 9SY, UK.
University of Glasgow · GBUniversity of Aberdeen · GBUniversity of Dundee · GBNinewells Hospital · GBQueen's Medical Centre · GBUniversity College London · GBUniversity of Edinburgh · GBUniversity of Michigan–Ann Arbor · USUniversity of Oxford · GBUniversity of Southern Denmark · DK

Funding

Medical Research Council G106/1249
6 · The paper itself

Abstract

backgroundSelective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting.

methodPatients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR).

resultsIn total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than celecoxib, but more patients withdrew from celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001).

interpretationIn subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib. CLINICAL

trial registrationhttps://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

Indexed as

Acute Coronary SyndromeAgedAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidCelecoxibCyclooxygenase 2 InhibitorsDenmarkDrug SubstitutionFemaleHospitalizationHumansMaleMiddle AgedMyocardial InfarctionNetherlandsOsteoarthritisAnti-Inflammatory Agents, Non-SteroidalCelecoxibCyclooxygenase 2 InhibitorsArthritisCardiovascularCelecoxibNSAIDs

Identifiers

PMID27705888
PMCPMC5837371
OpenAlexW2529472149

What OpenQuestion holds

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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 OpenQuestion graph.