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dc.contributor.authorYeomans, Neville D-
dc.contributor.authorGraham, D Y-
dc.contributor.authorHusni, M E-
dc.contributor.authorSolomon, D H-
dc.contributor.authorStevens, T-
dc.contributor.authorVargo, J-
dc.contributor.authorWang, Q-
dc.contributor.authorWisniewski, L M-
dc.contributor.authorWolski, K E-
dc.contributor.authorBorer, J S-
dc.contributor.authorLibby, P-
dc.contributor.authorLincoff, A M-
dc.contributor.authorLüscher, T F-
dc.contributor.authorBao, W-
dc.contributor.authorWalker, C-
dc.contributor.authorNissen, S E-
dc.identifier.citationAlimentary pharmacology & therapeutics 2018; 47(11): 1453-1463-
dc.description.abstractWe evaluated GI safety of celecoxib compared with 2 nonselective (ns) NSAIDs, as a secondary objective of a large trial examining multiorgan safety. This randomised, double-blind controlled trial analysed 24 081 patients. Osteoarthritis or rheumatoid arthritis patients, needing ongoing NSAID treatment, were randomised to receive celecoxib 100-200 mg b.d., ibuprofen 600-800 mg t.d.s. or naproxen 375-500 mg b.d. plus esomeprazole, and low-dose aspirin or corticosteroids if already prescribed. Clinically significant GI events (CSGIE-bleeding, obstruction, perforation events from stomach downwards or symptomatic ulcers) and iron deficiency anaemia (IDA) were adjudicated blindly. Mean treatment and follow-up durations were 20.3 and 34.1 months. While on treatment or 30 days after, CSGIE occurred in 0.34%, 0.74% and 0.66% taking celecoxib, ibuprofen and naproxen. Hazard ratios (HR) were 0.43 (95% CI 0.27-0.68, P = 0.0003) celecoxib vs ibuprofen and 0.51 (0.32-0.81, P = 0.004) vs naproxen. There was also less IDA on celecoxib: HR 0.43 (0.27-0.68, P = 0.0003) vs ibuprofen; 0.40 (0.25-0.62, P < 0.0001) vs naproxen. Even taken with low-dose aspirin, fewer CSGIE occurred on celecoxib than ibuprofen (HR 0.52 [0.29-0.94], P = 0.03), and less IDA vs naproxen (0.42 [0.23-0.77, P = 0.005]). Corticosteroid use increased total GI events and CSGIE. H. pylori serological status had no influence. Arthritis patients taking NSAIDs plus esomeprazole have infrequent clinically significant gastrointestinal events. Co-prescribed with esomeprazole, celecoxib has better overall GI safety than ibuprofen or naproxen at these doses, despite treatment with low-dose aspirin or corticosteroids.-
dc.titleRandomised clinical trial: gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial.-
dc.typeJournal Article-
dc.identifier.journaltitleAlimentary pharmacology & therapeutics-
dc.identifier.affiliationDepartment of Medicine, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia-
dc.identifier.affiliationWestern Sydney University, Campbelltown, NSW, Australia-
dc.identifier.affiliationBaylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA-
dc.identifier.affiliationCleveland Clinic, Cleveland, OH, USA-
dc.identifier.affiliationHarvard Medical School, Brigham and Women's Hospital, Boston, MA, USA-
dc.identifier.affiliationDownstate College of Medicine, State University of New York, New York, NY, USA-
dc.identifier.affiliationCardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland-
dc.identifier.affiliationPfizer, New York, NY, USA-
dc.identifier.affiliationPfizer Ltd, Tadworth, UK-
dc.type.austinJournal Article-, Neville D
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.languageiso639-1en- (University of Melbourne)- for Research-
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