Randomised clinical trial: gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial.
- Yeomans ND Department of Medicine, Austin Hospital, University of Melbourne, Melbourne, Victoria, Australia.
- Graham DY Baylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA.
- Husni ME Cleveland Clinic, Cleveland, OH, USA.
- Solomon DH Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.
- Stevens T Cleveland Clinic, Cleveland, OH, USA.
- Vargo J Cleveland Clinic, Cleveland, OH, USA.
- Wang Q Cleveland Clinic, Cleveland, OH, USA.
- Wisniewski LM Cleveland Clinic, Cleveland, OH, USA.
- Wolski KE Cleveland Clinic, Cleveland, OH, USA.
- Borer JS Downstate College of Medicine, State University of New York, New York, NY, USA.
- Libby P Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.
- Lincoff AM Cleveland Clinic, Cleveland, OH, USA.
- Lüscher TF Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.
- Bao W Pfizer, New York, NY, USA.
- Walker C Pfizer Ltd, Tadworth, UK.
- Nissen SE Cleveland Clinic, Cleveland, OH, USA.
- 2018-04-19
Published in:
- Alimentary pharmacology & therapeutics. - 2018
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Arthritis, Rheumatoid
Aspirin
Celecoxib
Double-Blind Method
Drug Therapy, Combination
Esomeprazole
Female
Gastrointestinal Diseases
Humans
Ibuprofen
Male
Middle Aged
Naproxen
Osteoarthritis
Treatment Outcome
English
AIM
To evaluate GI safety of celecoxib compared with 2 nonselective (ns) NSAIDs, as a secondary objective of a large trial examining multiorgan safety.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
To evaluate GI safety of celecoxib compared with 2 nonselective (ns) NSAIDs, as a secondary objective of a large trial examining multiorgan safety.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1111/apt.14610
- PMID 29667211
- Persistent URL
- https://fredi.hepvs.ch/global/documents/133037
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