Gastrointestinal tolerability of lumiracoxib in patients with osteoarthritis and rheumatoid arthritis.

BACKGROUND & AIMS: The aim of this study was to evaluate the gastrointestinal safety of lumiracoxib, a novel selective cyclooxygenase-2 inhibitor.

METHODS

Results from 15 Phase II and III randomized studies of lumiracoxib in osteoarthritis and rheumatoid arthritis were pooled. Patients received lumiracoxib (200/400 mg/day), celecoxib (200/400 mg/day), rofecoxib (25 mg once daily), diclofenac (75 mg twice daily), ibuprofen (800 mg 3 times daily), naproxen (500 mg twice daily), or placebo. Outcome measures included the incidence of definite or probable ulcer complications (perforations, obstructions, or bleedings as confirmed by an adjudication committee) and symptomatic upper gastrointestinal ulcers, the incidence of prespecified gastrointestinal adverse events, and the discontinuation rate caused by adverse events. All suspected ulcer complications in these 15 studies were adjudicated prospectively. Data from 2 endoscopic studies were pooled separately to assess the cumulative incidence of gastroduodenal ulcers >or=3 mm in diameter.

RESULTS

Symptomatic upper gastrointestinal ulcers and ulcer complications were reduced nearly 10-fold with lumiracoxib (1.7 events per 100 patient-years [95% confidence interval, 1.09-2.39]) compared with nonselective nonsteroidal anti-inflammatory drugs (13.7 events per 100 patient-years [95% confidence interval, 9.47-18.82]). Symptomatic ulcer frequency was markedly lower with lumiracoxib (0.4%) than with nonselective nonsteroidal anti-inflammatory drugs (2.5%). Discontinuation rates due to gastrointestinal adverse events were higher for nonselective nonsteroidal anti-inflammatory drugs (8.4%) than for lumiracoxib (3.3%). In the endoscopy analysis, the cumulative frequency of ulcers >or=3 mm in diameter was reduced by >70% for lumiracoxib versus ibuprofen.

CONCLUSIONS

Lumiracoxib exhibited a gastrointestinal safety profile superior to nonselective nonsteroidal anti-inflammatory drugs.