Reduced Incidence of Gastroduodenal Ulcers With Celecoxib, A Novel Cyclooxygenase-2 Inhibitor, Compared To Naproxen in Patients With Arthritis

• DOI: 10.1111/j.1572-0241.2001.03740.x
• Publication Date: 2004-03-29T10:45:50Z
• Authors: J L Goldstein; P Correa; W W Zhao; A M Burr; R C Hubbard; K M Verburg; G S Geis
• Keywords: Celecoxib; Valdecoxib; Gastroduodenal ulcer

OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) block prostaglandin production by inhibiting cyclooxygenase (COX); they are believed to cause gastroduodenal damage the COX-1 isoform and have analgesic effects COX-2 isoform. As compared conventional NSAIDs, celecoxib, a specific inhibitor, has been shown in previous single posttreatment endoscopy studies be associated with lower ulcer rates. In response concerns that such may under-represent ulceration rates, present serial study was designed compare cumulative rates use of celecoxib those naproxen, NSAID. METHODS: this double-blind, parallel-group, multicenter study, 537 patients osteoarthritis (OA) or rheumatoid arthritis (RA) were randomized treatment 200 mg b.i.d. (n = 270) naproxen 500 267) for 12 wk. Gastroduodenal determined from esophagogastroduodenoscopy after 4, 8, wk therapy. Arthritis efficacy evaluated Patient's Physician's Global Assessments. RESULTS: 4% versus 19% 0–4 interval (p < 0.001), 2% 14% 4–8 10% 8–12 respectively. After treatment, incidence ulcers 9% 41% naproxen. group, significantly Helicobacter pylori status 0.05), concurrent aspirin usage history 0.010), but not disease type (OA/RA), age, gender, other relevant medical histories, corticosteroid disease-modifying antirheumatic > 0.05). Celecoxib produced rate both gastric 0.001) duodenal 0.030) ulcers. The two agents similar improvements Assessments efficacy. adverse events withdrawal did differ between treatments. CONCLUSIONS: (500 b.i.d.), (200 agent, at recommended RA dose twice most frequently prescribed OA dose, gastric, duodenal, had comparable efficacy, RA.