Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis.

AIM

To test whether treatment with celecoxib reduces the incidence of gastroduodenal ulcers compared to diclofenac in Asian patients with osteoarthritis (OA) or rheumatoid arthritis (RA) with minimal significant risk factors.

METHODS

Patients with a clinical diagnosis of OA or RA of at least 3 months were randomized to 12 weeks of double-blind treatment with celecoxib 100 mg twice daily (n = 440) or diclofenac 50 mg twice daily (n = 440). The primary outcome was the gastric and/or duodenal ulcer rate at endpoint as determined by upper gastrointestinal endoscopy performed during the screening week, and at endpoint.

RESULTS

There was no significant difference in the overall incidence of gastroduodenal ulcers at 12-week endpoint for celecoxib compared to diclofenac (2.8% vs. 5.1%; Cochran-Mantel-Haenszel [CMH] chi(2) P = 0.083). However, there was a significantly lower incidence of gastric ulcers on celecoxib versus diclofenac (0.5% vs. 3.6%; CMH chi(2) P = 0.002). Approximately 59% of patients in both treatment groups had no visible gastric lesions at endpoint; and a similar proportion were found to have one or more erosions on celecoxib (n = 85; 21.4%) and diclofenac (N = 91; 23.3%). A survival analysis of time to ulcer was significant for gastric ulcers (log-rank P = 0.004), but not for duodenal ulcers, or for gastroduodenal ulcers combined. Fewer patients reported at least one adverse event on celecoxib compared to diclofenac (42.4% vs. 50.3%; chi(2), 5.52; P = 0.019).

CONCLUSIONS

In Asian patients with minimal significant risk factors, treatment with celecoxib was associated with a modest but significantly reduced incidence of gastric ulcers at the end of 12 weeks.