Background The Celecoxib Long-term Arthritis Safety Study (CLASS), a North American prospective outcomes study, demonstrated a significant reduction in UGI ulcer complications and improved tolerability.

Objectives To extend our understanding of the UGI safety advantages of celecoxib over conventional NSAIDs, a naturalistic study was conducted worldwide.

Methods SUCCESS I, a large, 12-week, multinational, prospective, double-blind, randomised trial in 13,274 osteoarthritis patients, was conducted in 39 countries. There were 6547 patients from Europe/Africa, 2756 from North America, 2889 from Latin America, and 1082 from Asia/Pacific. Celecoxib 200 mg/d (n = 4421) and 400 mg/d (n = 4429) was compared with naproxen 1000 mg/d (n = 914) and diclofenac 100 mg/d (n = 3510) with regard to UGI safety. Investigators were required to report all potential clinically significant UGI events and were allowed/requested to follow local standards of care with regard to work-up and treatment of events. Events data were collected prospectively. An independent Gastrointestinal Events Committee (GEC) reviewed all data in a blinded fashion. Events were categorised as UGI ulcer complications (perforations, gastric outlet obstruction, bleeding) or symptomatic UGI ulcerations (predefined as in CLASS). A total of 144 cases were reviewed and adjudicated by the GEC.

Results See Table 1.

Conclusion These data confirm CLASS results that celecoxib is associated with significantly fewer ulcer complications and symptomatic UGI ulcerations than conventional NSAIDs. The differences in event rates between SUCCESS and CLASS may relate to regional differences in surveillance or clinical practice.

Sponsored by Pharmacia Corporation and Pfizer, Inc.