Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study
- C J Hawkey 1, L Laine , T Simon
- 1University Hospital, Nottingham, United Kingdom. cj.hawkey@nottingham.ac.uk
- 0University Hospital, Nottingham, United Kingdom. cj.hawkey@nottingham.ac.uk
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View abstract on PubMed
Summary
This summary is machine-generated.Rofecoxib significantly reduced gastroduodenal ulcers in rheumatoid arthritis patients compared to naproxen. This selective COX-2 inhibitor showed a lower incidence of ulcers, suggesting improved gastrointestinal safety for NSAID users.
Area Of Science
- Gastroenterology
- Rheumatology
- Pharmacology
Background
- Previous research indicated selective cyclooxygenase (COX)-2 inhibitors like rofecoxib may cause less gastrointestinal damage than non-selective NSAIDs.
- This study investigated the incidence of gastroduodenal ulcers in rheumatoid arthritis patients treated with rofecoxib versus a non-selective NSAID.
Purpose Of The Study
- To compare the incidence of endoscopically detected gastroduodenal ulcers in rheumatoid arthritis patients receiving rofecoxib or naproxen.
- To evaluate the gastrointestinal safety profile of rofecoxib in this patient population.
Main Methods
- A 12-week, multicentre, randomized, double-blind study involving rheumatoid arthritis patients.
- Patients were assigned to rofecoxib 50 mg daily, naproxen 500 mg twice daily, or placebo.
- Endoscopic evaluation for gastroduodenal ulcers and erosions was performed at baseline and at 6 and 12 weeks.
Main Results
- The cumulative incidence of ulcers (≥3 mm) at 12 weeks was significantly higher with naproxen (25.5%) compared to rofecoxib (6.8%) and placebo (2.9%).
- The difference in ulcer incidence between rofecoxib and placebo was not statistically significant (p=0.066).
- Adverse event incidence was similar across all treatment groups.
Conclusions
- Rofecoxib 50 mg daily demonstrated a lower incidence of endoscopically detected gastroduodenal ulcers and erosions compared to naproxen 500 mg twice daily.
- These findings suggest a potential gastrointestinal benefit of rofecoxib over naproxen in rheumatoid arthritis patients, despite a higher than recommended dose.
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