Efficacy and tolerability of oxaprozin in the elderly

Abstract

Retrospective data from controlled clinical trials with Oxaprozin, an investigational nonsteroidal antiinflammatory drug (NSAID), were stratified by patient age to ascertain whether the drug is as safe and effective in patients over 60 years old as it is in younger patients. Data for 1.423 patients with rheumatoid arthritis (RA) and osteoarthritis (OA) were studied; 1,012 of these patients received Oxaprozin (600 to 1,800 mg daily), 232 received aspirin (2,600 to 3,900 mg daily), and 179 received ibuprofen (1,200 to 2,400 mg daily). The three drugs were equally effective in treating RA and OA, and efficacy measures indicated similar improvement in patients of both age groups. Elderly patients who received Oxaprozin, aspirin, or ibuprofen were more likely to have gastrointestinal and hematologic adverse effects than their younger counterparts, and older patients who received Oxaprozin or aspirin therapy were also more likely to have adverse renal effects. The incidence of hepatic side effects was very low and comparable with all three drugs, both in older and younger patients. Thus, Oxaprozin is no more likely than other NSAIDs to increase the risk of gastrointestinal, hematologic, or renal toxicity among elderly patients with RA or OA, and the incidence of these forms of toxicity varies depending on the underlying disease. Such factors as concomitant disease, organ dysfunction, or medication may contribute to the increased incidence of NSAID toxicity observed among older patients.