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The gastrointestinal (GI) safety profile of widely prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) in Asia-Pacific populations remains underexplored.
Loxoprofen and mefenamic acid show markedly lower gastrointestinal hospitalization risk than diclofenac in select Asia-Pacific populations.
The gastrointestinal (GI) safety profile of widely prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) in Asia-Pacific populations remains underexplored. Hence, this multinational study explored the risk of GI hospitalization linked with loxoprofen and mefenamic acid compared with diclofenac and celecoxib across real-world Asian and Australian cohorts.
Researchers conducted a large population-based cohort study using a distributed research network built on a common data model across Australia, Taiwan, Hong Kong, Japan, and Korea. Adult patients newly prescribed diclofenac, loxoprofen, mefenamic acid, or celecoxib were included. Volunteers were followed from NSAID initiation until the first hospitalization for GI complications, treatment discontinuation or switch, database exit, or end of study period. For GI hospitalization risk, cox proportional hazards regression models were used for estimating adjusted hazard ratios (HRs) along with 95% confidence intervals.
The study included 9,879 NSAID initiators in Japan, 70,492 in Taiwan, 263,741 in Korea, 246 in Hong Kong, and 44,013 in Australia (predominantly Caucasian population). Incidence rates of GI hospitalization per 1,000 person-years were
Compared with diclofenac, loxoprofen was related to a substantially reduced risk of GI hospitalization in Korea (HR 0.37), but no statistically significant difference was noted in Japan (HR 1.65). Mefenamic acid illustrated a considerably lower risk in Taiwan (HR 0.45) and Korea (HR 0.11), while no pivotal reduction was seen in Hong Kong (HR 2.16).
In this large real-world, multi-country Asia-Pacific analysis, loxoprofen exhibited a lower risk of GI hospitalization compared with diclofenac in South Korea, while mefenamic acid showed reduced GI risk in Taiwan and Korea. These findings yield important evidence for NSAID safety, GI bleeding risk assessment, and region-specific prescribing decisions.
Pharmacoepidemiology and Drug Safety
Comparative safety of NSAIDs for gastrointestinal events in Asia-Pacific populations: A multi-database, international cohort study
Edward Chia-Cheng Lai et al.
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