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Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly prescribed medications worldwide; however, prolonged NSAID therapy is strongly linked with an increased risk of upper gastrointestinal (GI) complications, including gastroduodenal ulceration.
Celecoxib substantially reduces the incidence of endoscopic gastroduodenal ulcers compared with loxoprofen while maintaining a favorable safety profile.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly prescribed medications worldwide; however, prolonged NSAID therapy is strongly linked with an increased risk of upper gastrointestinal (GI) complications, including gastroduodenal ulceration. This study sought to explore whether celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, offers superior gastroduodenal safety compared with loxoprofen by assessing the incidence of endoscopically confirmed gastroduodenal ulcers.
A randomized phase IV clinical trial was executed in healthy Japanese adults (mean age 57.5 years; 40–74 years; >70% female). Volunteers were stratified according to Helicobacter pylori (H. pylori) infection status (~40% positive) and randomly allocated (2:2:1) to get celecoxib 100 mg twice daily, loxoprofen 60 mg three times daily, or placebo for 2 weeks. The primary endpoint ascertained was the occurrence of gastroduodenal ulcers detected by endoscopy at the end of treatment.
Among 190 randomized subjects, 189 received a minimum of one dose of medication. The incidence of gastroduodenal ulcers was markedly lower in the celecoxib group (1.4%) compared with the loxoprofen group (27.6%) and placebo group (2.7%). Overall adverse event rates were 34.2% with celecoxib, 51.3% with loxoprofen, and 21.6% with placebo. Across all treatment arms, no severe adverse events were reported.
Celecoxib depicted clear superiority over loxoprofen in minimizing the risk of gastroduodenal endoscopic ulcers over a two-week treatment period. Celecoxib was well-tolerated, with a favorable GI safety profile and no profound safety concerns, supporting its role as a safer NSAID option for those at risk of GI complications.
Alimentary Pharmacology & Therapeutics
Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study
C Sakamoto et al.
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