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Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial

Jankowski, Janusz A.Z.; de Caestecker, John; Love, Sharon B.; Reilly, Gavin; Watson, Peter; Sanders, Scott; Ang, Yeng; Morris, Danielle; Bhandari, Pradeep; Attwood, Stephen; Ragunath, Krish; Rameh, Bashir; Fullarton, Grant; Tucker, Art; Penman, Ian; Rodgers, Colin; Neale, James; Brooks, Claire; Wise, Adelyn; Jones, Stephen; Church, Nicholas; Gibbons, Michael; Johnston, David; Vaidya, Kishor; Anderson, Mark; Balata, Sherzad; Davies, Gareth; Dickey, William; Goddard, Andrew; Edwards, Cathryn; Gore, Stephen; Haigh, Chris; Harding, Timothy; Isaacs, Peter; Jackson, Lucina; Lee, Thomas; Lim, Peik Loon; Macdonald, Christopher; Mairs, Philip; McLoughlin, James; Monk, David; Murdock, Andrew; Murray, Iain; Preston, Sean; Pugh, Stirling; Smart, Howard; Soliman, Ashraf; Todd, John; Turner, Graham; Worthington, Joy; Harrison, Rebecca; Barr, Hugh; Moayyedi, Paul

Authors

Janusz A.Z. Jankowski

John de Caestecker

Sharon B. Love

Gavin Reilly

Peter Watson

Scott Sanders

Yeng Ang

Danielle Morris

Pradeep Bhandari

Stephen Attwood

Krish Ragunath K.Ragunath@nottingham.ac.uk

Bashir Rameh

Grant Fullarton

Art Tucker

Ian Penman

Colin Rodgers

James Neale

Claire Brooks

Adelyn Wise

Stephen Jones

Nicholas Church

Michael Gibbons

David Johnston

Kishor Vaidya

Mark Anderson

Sherzad Balata

Gareth Davies

William Dickey

Andrew Goddard

Cathryn Edwards

Stephen Gore

Chris Haigh

Timothy Harding

Peter Isaacs

Lucina Jackson

Thomas Lee

Peik Loon Lim

Christopher Macdonald

Philip Mairs

James McLoughlin

David Monk

Andrew Murdock

Iain Murray

Sean Preston

Stirling Pugh

Howard Smart

Ashraf Soliman

John Todd

Graham Turner

Joy Worthington

Rebecca Harrison

Hugh Barr

Paul Moayyedi



Abstract

Background: Oesophageal adenocarcinoma (OA) is the sixth commonest cause of cancer death worldwide and Barrett’s oesophagus (BO) is the most significant risk factor. We evaluated the efficacy of high-dose esomeprazole proton pump inhibitor acid suppression (PPI) and aspirin in improving outcome for BO patients in the largest such randomized controlled trial.
Methods: Patients with ≥1cm BO in UK and Canadian hospitals were randomized 1:1:1:1 using a computer-generated schedule held in a central trials unit in a 2X2 factorial design to high-dose (40mg twice-daily) or low-dose (20mg once-daily) PPI, alone or with aspirin (UK: 300mg/day, Canada: 325mg/day), unblinded (reporting pathologists blinded). The primary composite endpoint was time to all-cause mortality, OA, or high-grade dysplasia, analysed using accelerated failure time modelling adjusted for minimization factors (age, BO length, intestinal metaplasia).
Findings: Recruited patients (N=2557) were followed for 8·9 years (median; interquartile range 8·2–9·8), collecting 20,095 follow-up years and 99·9% of planned data. There were 313 primary events. High-dose PPI was superior to low-dose PPI (p=0·037, N=1265 (low dose), N=1270 (high dose), time ratio (TR)=1·27, 95%CI=1·01–1·58). Aspirin was not significantly better than no aspirin (p=0·068, N=1142 (no aspirin), N = 1138 (aspirin), TR=1·24, 95%CI=0·98–1·57). If patients using NSAIDs were censored at time of first use,aspirin was significantly better than no Aspirin (p=0·043, N=2,236, TR=1·29 95%CI=1·01– 1·66). Combining high-dose PPI with aspirin had the strongest effect compared with low dose PPI without aspirin (p=0·0068, TR=1·59, 95%CI=1·14–2·23). NNT for PPI and aspirin benefit is 34 and 43, respectively. Only 1·0% (28) of participants reported study-treatment related serious adverse events.
Interpretation: High-dose PPI and aspirin chemoprevention therapy, especially in combination, significantly and safely improve outcome in BO patients.

Citation

Jankowski, J. A., de Caestecker, J., Love, S. B., Reilly, G., Watson, P., Sanders, S., …Moayyedi, P. (2018). Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial. Lancet, 392(10145), (400-408). doi:10.1016/S0140-6736(18)31388-6. ISSN 1474-547X

Journal Article Type Article
Acceptance Date Jun 27, 2018
Online Publication Date Jul 26, 2018
Publication Date Aug 4, 2018
Deposit Date Jul 11, 2018
Publicly Available Date Jul 26, 2018
Journal Lancet Gastroenterology and Hepatology
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 392
Issue 10145
Pages 400-408
DOI https://doi.org/10.1016/S0140-6736%2818%2931388-6
Keywords Aspirin, Barrett’s oesophagus, cancer, chemoprevention, randomized clinical trial, proton pump inhibitors.
Public URL http://eprints.nottingham.ac.uk/id/eprint/52852
Publisher URL https://www.sciencedirect.com/science/article/pii/S0140673618313886?via%3Dihub
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0
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