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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
Author(s) -
CHEUNG Raymond,
CHENG TienTsai,
DONG Yi,
LIN HsiaoYi,
LAI Kamchuen,
LAU Chaksing,
FENG Huang,
PARSONS Bruce
Publication year - 2010
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/j.1756-185x.2010.01463.x
Subject(s) - medicine , diclofenac , celecoxib , osteoarthritis , rheumatoid arthritis , gastroenterology , incidence (geometry) , arthritis , clinical endpoint , adverse effect , clinical trial , anesthesia , pathology , optics , physics , alternative medicine
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] χ 2 P = 0.083). However, there was a significantly lower incidence of gastric ulcers on celecoxib versus diclofenac (0.5% vs. 3.6%; CMH χ 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%; χ 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.