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Eur Heart J. 2017 Jun 14;38(23):1843-1850. doi: 10.1093/eurheartj/ehw387.

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

Author information

1
Medicines Monitoring Unit (MEMO), Division of Molecular & Clinical Medicine, University of Dundee, Ninewells Hospital & Medical School Dundee, Dundee DD1 9SY, UK.
2
Faculty of Medicine & Health Sciences, University of Nottingham, Queen's Medical Centre Nottingham, Nottingham NG7 2UH, UK.
3
Robertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ, UK.
4
British Heart Foundation Cardiovascular Research Centre, University of Glasgow,126 University Place, GlasgowG12 8TA, UK.
5
Division of Gastroenterology, University of Michigan Medical School, 1500 E Medical Center Drive, Ann Arbor, MI 48109, USA.
6
Department of Public Health, Clinical Pharmacology, University of Southern Denmark, J. B. Winsløws Vej 19, 2.5000 Odense, Denmark.
7
Julius Center for Health Sciences and Primary Care and Julius Clinical Academic Research Organization, Utrecht, The Netherlands.
8
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.
9
Centre for Genomic and Experimental Medicine, Institute of Genetics and Molecular Medicine, University of Edinburgh, Western General Hospital Edinburgh, Edinburgh EH4 2XU, UK.
10
School of Medicine & Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
11
Department of Cardiology, University Heart Center, Rämistrasse 100, 8091Zürich, Switzerland.
12
Centre of Academic Primary Care, School of Medicine and Dentistry, University of Aberdeen, AberdeenAB25 2ZD, UK.
13
RTI Health Solutions, Trav. Gracia 56, Atico 1, Barcelona 08006, Spain.
14
Department of Practice and Policy, University College London, London WC1H 9JP, UK.

Erratum in

Abstract

Background:

Selective 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.

Method:

Patients 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).

Results:

In 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).

Interpretation:

In 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 Registration:

https://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

KEYWORDS:

Arthritis; Cardiovascular; Celecoxib; NSAIDs

PMID:
27705888
PMCID:
PMC5837371
DOI:
10.1093/eurheartj/ehw387
[Indexed for MEDLINE]
Free PMC Article

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