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Title: Randomised clinical trial: gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial.
Austin Authors: Yeomans, Neville D ;Graham, D Y;Husni, M E;Solomon, D H;Stevens, T;Vargo, J;Wang, Q;Wisniewski, L M;Wolski, K E;Borer, J S;Libby, P;Lincoff, A M;Lüscher, T F;Bao, W;Walker, C;Nissen, S E
Affiliation: Department of Medicine, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia
Western Sydney University, Campbelltown, NSW, Australia
Baylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA
Cleveland Clinic, Cleveland, OH, USA
Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA
Downstate College of Medicine, State University of New York, New York, NY, USA
Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland
Pfizer, New York, NY, USA
Pfizer Ltd, Tadworth, UK
Issue Date: 2018
Date: 2018-04-17
Publication information: Alimentary pharmacology & therapeutics 2018; 47(11): 1453-1463
Abstract: We 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.
DOI: 10.1111/apt.14610
ORCID: 0000-0001-9870-832X
Journal: Alimentary pharmacology & therapeutics
PubMed URL: 29667211
Type: Journal Article
Appears in Collections:Journal articles

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