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Gastrointestinal toxicity in elderly osteoarthritis patients treated with NSAIDs

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image of Inflammopharmacology

Purpose: The elderly are at increased risk for gastrointestinal (GI) toxicity during treatment with nonsteroidal anti-inflammatory drugs (NSAID). Previous studies have suggested that nabumetone is associated with fewer perforations, ulcers, and bleeds (PUBs) than older NSAIDs in the general arthritis population. The purpose of this analysis was to evaluate the risk of upper GI PUBs associated with nabumetone and various comparator NSAIDs in elderly patients with osteoarthritis.Methods: Because GI PUBs associated with NSAID use are not common, the results of seven randomized, double-blind studies carried out in the US, Canada, and UK were pooled to compare the safety and efficacy of nabumetone and various comparator NSAIDs in an elderly subset of patients with osteoarthritis (OA). Outpatients with moderate to severe osteoarthritis of the knee or hip presenting to a rheumatologist's practice were eligible for enrolment. All studies had a treatment duration of 3-6 months. These studies were pooled and a retrospective analysis of the frequency of upper GI PUBs for each treatment group was performed. Elderly were defined as age ? 65.Results: A total of 2613 patients with OA were treated with nabumetone (1308) or comparator NSAIDs (1305). Of the nabumetone-treated patients, 47% (614/1308) were ?65 years of age and of the patients treated with comparator NSAIDs, 50% (655/1305) were ? 65 years. The raw frequency of PUBs in the elderly population was 0% (0/614) for patients treated with nabumetone and 1.1% (7/655) in patients treated with comparator NSAIDs (p < 0.02 by a Fisher's Exact Test). This was equivalent to 0 in approximately 243.5 patient-years of exposure with nabumetone compared with 7/263.8 or 2.7 per 100 patient-years of exposure with comparator NSAIDs. Six of the seven comparator PUBs were classified as complications and one was an uncomplicated peptic ulcer.Conclusions: In this analysis of PUBs in an elderly population with osteoarthritis, nabumetone use was associated with significantly fewer PUBs and significantly fewer complications than were the comparator NSAIDs used in these studies.


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