Clinical-alimentary tractCelecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial
Section snippets
Study population and setting
We screened consecutive patients with arthritis who presented with ulcer bleeding while receiving NSAIDs to the Endoscopy Center of Prince of Wales Hospital at The Chinese University of Hong Kong. The inclusion criteria were ulcer healing confirmed on follow-up endoscopy, a negative test for Helicobacter pylori or successful eradication of Helicobacter pylori based on histology, and anticipated regular use of NSAIDs for the duration of the trial. The exclusion criteria were concomitant use of
Results
A total of 287 patients were enrolled. Twenty-four patients developed recurrent GI bleeding; 7 in the celecoxib group and 9 in the diclofenac plus omeprazole group were adjudicated to have recurrent ulcer bleeding according to prespecified criteria.10 Among patients with recurrent ulcer bleeding, 3 used concomitant low-dose aspirin (1 in the celecoxib group and 2 in the diclofenac plus omeprazole group), and 1 who received diclofenac plus omeprazole had relapse of H. pylori infection. Eighteen
Discussion
We studied the overall incidence of ulcers to evaluate the gastric safety of long-term treatment with celecoxib or diclofenac plus omeprazole in very high-risk patients, i.e., those with a recent episode of ulcer bleeding. Among patients without recurrent gastrointestinal complications within the study period, the incidence of recurrent gastroduodenal ulcers was unexpectedly high: 19% of patients receiving celecoxib and 26% of patients receiving diclofenac plus omeprazole had recurrent ulcers
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Supported by a research grant from the Health Services Research Committee of Hong Kong (HSRC S111009).
Dr. Francis Chan received a consulting fee from Pfizer in 2002.