AGE AND RISK OF NSAID-INDUCED UPPER GASTROINTESTINAL (UGI) SYMPTOMS: ANALYSIS OF SUCCESS I, A DOUBLE BLIND, RANDOMIZED, CONTROLLED TRIAL IN 13,194 PATIENTS WITH OSTEOARTHRITIS (OA)

Background: Age has been identified as a risk factor for NSAID-induced, serious UGI events. However, there is little data on the relationship of age with NSAID-induced dyspepsia. While it is known that COX-2 specific inhibitors are associated with an improved UGI tolerability compared to nonspecific NSAIDs, it is unclear whether this advantage persists across age groups.Objectives: To determine the effect of increasing age on the incidence of NSAID-induced UGI symptoms and to compare the rate of UGI symptoms in patients on celecoxib and non-specific NSAIDs in different age groups.Methods: SUCCESS I, a double blind, randomized controlled trial enrolled 13,194 (ITT population) in over 39 countries. Patients were 76% female with a mean age of 62 years and a diagnosis of OA of the hip, knee or hand. Of these, 8,800 took celecoxib at a dose of 200-400 mg/day and 4,394 took NSAIDs (naproxen 1000 mg/day or diclofenac 100 mg/day). Adverse events were reported by investigators and classified using World Health Organization standardized coding and terminology. All mild, moderate and severe abdominal pain, nausea or dyspepsia were designated as NSAID-induced UGI events and analyzed.Results: There was no correlation between age and incidence of UGI symptoms in both treatment arms. For all ages, the incidence of UGI symptoms was significantly higher in patients taking NSAIDs compared to those on celecoxib (OR 1.34; 95% CI: 1.20-1.49; P<.0001). Percent Incidence Age <45 46-55 56-65 66-75 >75 NSAIDs 13 14 14 13 14 Celecoxib 10 11 11 9 10 ]Conclusion: Increasing age is not a risk factor for the development of NSAID-induced UGI symptoms. Celecoxib was associated with a significant reduction in UGI symptoms as compared to NSAIDs regardless of a patient's age.Disclosure: Sponsored by Pharmacia Corporation and Pfizer Incorporated.Citation: , volume , supplement , year 2003, page Session: Osteoarthritis – Clinical aspects and treatment