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Randomised clinical trial: Gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial

Alimentary Pharmacology and Therapeutics Apr 25, 2018

Yeomans ND, et al. - Authors assessed the GI safety of celecoxib compared with 2 nonselective (ns) NSAIDs, as a secondary objective of a large trial examining multiorgan safety. Infrequent clinically significant gastrointestinal events were seen in arthritis patients taking NSAIDs plus esomeprazole. Celecoxib had better overall GI safety than ibuprofen or naproxen at these doses when co-prescribed with esomeprazole, despite treatment with low-dose aspirin or corticosteroids.

Methods

  • Experts analyzed 24,081 patients in this randomised, double-blind controlled trial.
  • They randomised osteoarthritis or rheumatoid arthritis patients, needing ongoing NSAID treatment, 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.
  • Researchers blindly adjudicated clinically significant GI events (CSGIE—bleeding, obstruction, perforation events from stomach downwards or symptomatic ulcers) and iron deficiency anaemia (IDA).

Results

  • As per the data, mean treatment and follow-up durations were 20.3 and 34.1 months.
  • Authors nothed that while on treatment or 30 days after, CSGIE occurred in 0.34%, 0.74% and 0.66% taking celecoxib, ibuprofen and naproxen.
  • Findings suggested that 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.
  • Results demonstrated that 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, compared to ibuprofen (HR 0.52 [0.29-0.94],P=0.03), fewer CSGIE occurred on celecoxib, and less IDA vs naproxen (0.42 [0.23-0.77,P=0.005]).
  • Total GI events and CSGIE were increased by corticosteroid use.
  • No influence of H. Pyloriserological status was noted.

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