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Background: Non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (GI) adverse events are well-described in the Western population but data is lacking in Asian patients. This study aims to describe the incidence and predictive factors for NSAID-induced upper GI complications in a cohort of multi-ethnic patients in Malaysia. Methods and Findings: A retrospective cohort study was conducted in adult patients with rheumatoid arthritis (RA) and/or osteoarthritis (OA) from 2010-2013 in four main rheumatology centres in Malaysia with computerized clinical and pharmaceutical records. Clinical, pharmaceutical and demographic data over a 24-months follow-up period were analysed in subjects who were prescribed long-term NSAID therapy (defined as a minimum duration of four weeks). 634 patients were included in the final analysis with the following characteristics: mean age 53.4 ± 12.5 years, 89.9% female, diagnosis: RA 59.5%, OA 10.2% and RA/OA combination 30.3%. 371 (58.5%) patients received non-selective NSAIDs and 263 (41.5%) patients received COX-2 inhibitors. There were a total of 84 GI adverse events during the period of study, giving an incidence rate of 66.2 per 1000 person-years and a risk of 13.2%. The majority of upper GI adverse events was dyspepsia (92.9%), and only 7.1% with peptic ulcer disease/ upper GI bleeding. Multivariate analysis showed that the only independent predictive factor of upper GI adverse event in this cohort was a history of upper GI disease (O.R. 2.073, 95% C.I. 1.029 – 4.176). COX-2 inhibitor showed a trend towards, but not independently predictive of, GI protection in this analysis (OR 0.643; 95% C.I. 0.397 – 1.043). Conclusion: Malaysian rheumatic patients on long-term NSAID therapy, managed at referral centres, have a 13.2% risk of upper GI adverse events, with dyspepsia being the commonest complication. Patients with a history of upper GI disease were twice as likely to develop further upper GI adverse events with the use of long-term NSAIDs.

Risk of upper gastrointestinal adverse events in Malaysian rheumatic patients on long-term non-steroidal antiinflammatory drugs