Article Text


SAT0097 Success in osteoarthritis (oa) trial: celecoxib significantly reduces the risk of upper gastrointestinal (ugi) hospitalizations compared to diclofenac and naproxen in 13,274 randomised patients with oa
  1. J Goldstein1,
  2. G Eisen2,
  3. W Bensen3,
  4. N Agrawal4,
  5. G Singh5,
  6. K Pavelka6,
  7. TA Burke7,
  8. JVM Chancellor8,
  9. AD Pettitt8,
  10. AM Wilson9,
  11. J Fort7
  1. 1Department of Medicine, University of Illinois at Chicago, Chicago, USA
  2. 2Vanderbilt University School of Medicine, Nashville, USA
  3. 3St. Jospeh’s Hospital and McMaster University, Ontario, Canada
  4. 4Division of Gastroenterology, Duke University, Durham, USA
  5. 5Stanford University, Palo Alto, USA
  6. 6Czech Rheumatological Society, Prague, Czech Republic
  7. 7Pharmacia Corporation, Peapack, USA
  8. 8Global Health Outcomes, Pharmacia, Bucks, UK
  9. 9Pfizer Inc., New York, USA


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.

Abstract SAT0097 Table 1

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.

Statistics from

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.