Reduced incidence of gastroduodenal ulcers associated with lumiracoxib compared with ibuprofen in patients with rheumatoid arthritis
Article first published online: 29 APR 2004
Alimentary Pharmacology & Therapeutics
Volume 19, Issue 11, pages 1189–1198, June 2004
How to Cite
Kivitz, A. J., Nayiager, S., Schimansky, T., Gimona, A., Thurston, H. J. and Hawkey, C. (2004), Reduced incidence of gastroduodenal ulcers associated with lumiracoxib compared with ibuprofen in patients with rheumatoid arthritis. Alimentary Pharmacology & Therapeutics, 19: 1189–1198. doi: 10.1111/j.1365-2036.2004.01956.x
- Issue published online: 29 APR 2004
- Article first published online: 29 APR 2004
- Accepted for publication 17 March 2004
Background : Lumiracoxib (Prexige; Novartis Pharma AG, Basel, Switzerland) is a cyclooxygenase-2 selective inhibitor associated with improved gastrointestinal safety compared with nonsteroidal anti-inflammatory drugs, in patients with osteoarthritis.
Aim : To compare the gastroduodenal safety of lumiracoxib with ibuprofen and celecoxib in patients with rheumatoid arthritis.
Methods : A total of 893 patients with rheumatoid arthritis were randomized to lumiracoxib 400 mg once daily, lumiracoxib 800 mg once daily, ibuprofen 800 mg three times daily or celecoxib 200 mg twice daily for 13 weeks, in a double-blind randomised controlled clinical trial. The primary endpoint was the cumulative incidence of gastroduodenal ulcers over 13 weeks.
Results : The incidence of gastroduodenal ulcers ≥3 mm with lumiracoxib 400 mg once daily (2.8%) or lumiracoxib 800 mg once daily (4.3%) was significantly lower than with ibuprofen (13.6%, all P < 0.01) and not different from celecoxib (1.9%). The incidence of adverse events was similar for lumiracoxib 400, 800 mg and celecoxib (78, 75 and 77%, respectively) and higher with ibuprofen (86%). Discontinuation for adverse events was highest for ibuprofen (12.5% vs. 7.9–8.8% for the other groups).
Conclusions : Lumiracoxib demonstrated gastroduodenal safety superior to ibuprofen and similar to celecoxib in patients with rheumatoid arthritis.