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Clinically significant gastrointestinal (GI) adverse events rarely occurred in patients with arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs) with esomeprazole, according to a new study published in Alimentary Pharmacology and Therapeutics.
The randomized, double-blind, controlled trial (N=24,081) included patients with rheumatoid arthritis or osteoarthritis who required chronic NSAID treatment. Study patients were randomized to celecoxib 100 to 200mg twice daily, ibuprofen 600 to 800mg three times daily or naproxen 375 to 500mg twice daily plus esomeprazole; patients were allowed to continue with low-dose aspirin or corticosteroids if already prescribed. Researchers analyzed the incidence of clinically significant GI events (defined as bleeding, obstruction, perforation events from stomach downwards or symptomatic ulcers) and iron deficiency anemia (IDA).
During treatment and up to 30 days after, clinically significant GI events were seen in 0.34% of patients taking celecoxib, 0.66% of patients taking naproxen, and 0.74% of patients taking ibuprofen. The hazard ratios (HR) were 0.43 (95% CI: 0.0.27–0.62; P =.0003) for celecoxib vs ibuprofen, and 0.51 (95% CI: 0.32–0.81; P =.004) for celecoxib vs naproxen.
There were fewer incidences of IDA with celecoxib (HR 0.43, 95% CI: 0.27–0.68; P =.0003) vs ibuprofen (HR 0.40, 95% CI: 0.25–0.62; P <.0001) vs naproxen. Celecoxib taken with concomitant low-dose aspirin still exhibited fewer clinically significant GI events than with ibuprofen (HR 0.52, 95% CI: 0.29–0.94; P =.03), and fewer IDA occurrences vs naproxen (HR 0.42, 95% CI: 0.23–0.77; P =.005).
Concomitant use of corticosteroids was associated with increased total GI events and clinically significant GI events, while H. pylori status had no influence on the outcome.
“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,” the authors concluded.
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