Comparative safety of NSAIDs for gastrointestinal events in Asia-Pacific populations: A multi-database, international cohort study
Comparative safety of NSAIDs for gastrointestinal events in Asia-Pacific populations: A multi-database, international cohort study
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DOI：
10.1002/pds.4663
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发表时间：
2018-11-01
影响因子：
2.6
通讯作者：
Setoguchi, Soko
中科院分区：
文献类型：
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作者：
Lai, Edward Chia-Cheng;Shin, Ju-Young;Setoguchi, Soko
目的亚太地区国家常用的非甾体抗炎药（NSAIDs）的安全性研究有限。我们评估了亚太地区人群中洛索洛芬和甲芬那酸与其他NSAID相比因胃肠道事件住院的风险。方法结果我们在澳大利亚、中国香港、日本、韩国和中国台湾地区使用具有通用数据模型的分布式网络进行了一项队列研究。我们纳入了开始使用双氯芬酸、洛索洛芬、甲芬那酸或塞来昔布的患者，并对其进行随访，直至其首次胃肠道住院、转换或停用药物、退出研究或数据库覆盖结束。我们使用考克斯比例风险模型来评估住院风险。我们确定了9879例日本患者、70492例台湾患者、263741例韩国患者和246例香港患者开始使用NSAID，以及44013例澳大利亚患者（主要是白人人群）。日本、中国台湾、韩国、中国香港和澳大利亚的胃肠道住院发生率分别为25.6/1000人-年、32.8/1000人-年、11.5/1000人-年、484.5/1000人-年和35.6/1000人-年。与双氯芬酸相比，洛索洛芬在韩国的胃肠道事件风险显著较低（风险比，0.37; 95% CI，0.25-0.54），但在日本并非如此（1.65; 95% CI，0.47-5.78）。与双氯芬酸相比，中国台湾（0.45; 95% CI，0.26-0.78）和韩国（0.11; 95% CI，0.05-0.27）使用甲芬那酸的胃肠道事件风险显著较低，但中国香港（2.16; 95% CI，0.28-16.87）未发生。结论与双氯芬酸相比，洛索洛芬在韩国的胃肠道住院风险较低，甲芬那酸在台湾和韩国的风险较低。
Purpose The safety of nonsteroidal anti-inflammatory drugs (NSAIDs) commonly used in Asia-Pacific countries has had limited study. We assessed the risk of hospitalization for gastrointestinal events with loxoprofen and mefenamic acid compared with other NSAIDs in Asia-Pacific populations. Methods Results We conducted a cohort study using a distributed network with a common data model in Australia, Hong Kong, Japan, Korea, and Taiwan. We included patients who initiated diclofenac, loxoprofen, mefenamic acid, or celecoxib and followed them until their first gastrointestinal hospitalization, switch or discontinuation of medication, disenrollment, or end of database coverage. We used Cox proportional hazards models to assess hospitalization risk. We identified 9879 patients in Japan, 70 492 in Taiwan, 263 741 in Korea, and 246 in Hong Kong who initiated an NSAID, and 44 013 patients in Australia, a predominantly Caucasian population. The incidence of gastrointestinal hospitalization was 25.6 per 1000 person-years in Japan, 32.8 in Taiwan, 11.5 in Korea, 484.5 in Hong Kong, and 35.6 in Australia. Compared with diclofenac, the risk of gastrointestinal events with loxoprofen was significantly lower in Korea (hazards ratio, 0.37; 95% CI, 0.25-0.54) but not in Japan (1.65; 95% CI, 0.47-5.78). The risk of gastrointestinal events with mefenamic acid was significantly lower in Taiwan (0.45; 95% CI, 0.26-0.78) and Korea (0.11; 95% CI, 0.05-0.27) but not Hong Kong (2.16; 95% CI, 0.28-16.87), compared with diclofenac. Conclusions Compared with diclofenac, loxoprofen was associated with a lower risk of gastrointestinal hospitalizations in Korea and mefenamic acid with a lower risk in Taiwan and Korea.