Background NSAIDs increase the risk of serious GI hospitalizations, with studies demonstrating 5–7x increases in risk (1%?1.5% NSAID vs 0.1%-0.2% background rates). Additionally, GI-related hospitalizations impose higher cost on payers.
Objectives To compare the incidence of upper GI (UGI) hospitalizations in OA patients exposed to celecoxib, a COX-2 specific inhibitor, or conventional NSAIDs (diclofenac or naproxen).
Methods SUCCESS-1 in OA was a 12-week, multinational, double-blind, randomised trial in 13,274 patients, designed to reflect standard clinical practice. 6547 patients from Europe and Africa; 2756 from North America; 2889 from Latin America and 1082 from Australasia were enrolled. Patients were treated with celecoxib (200 mg/d [n = 4421] or 400 mg/d [n = 4429]) or conventional NSAIDs (naproxen 1000 mg/d [n = 914] or diclofenac 100 mg/d [n = 3510]). An independent Gastrointestinal Events Committee (GEC) categorised potential clinically significant UGI events in a blinded fashion as UGI ulcer complications (perforations, gastric outlet obstruction, bleeding) or symptomatic UGI ulcerations. UGI hospitalizations are reported as GI body system code events, investigator-determined potential UGI events, and GEC-confirmed ulcers/ulcer complications.
Conclusion UGI hospitalisation rates were 2–4x lower, and less UGI-related healthcare resources were utilised for celecoxib- vs NSAID-treated patients. The incidence of serious clinical UGI safety endpoints was significantly lower in the celecoxib-treated patients. Sponsored by Pharmacia Corporation and Pfizer, Inc.
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