CHIEN-CHANG LEEChang S.-S.Lee S.-H.Chen Y.-S.Hsu W.-T.Gabriel Lee M.-T.2020-12-162020-12-1620152045-2322https://scholars.lib.ntu.edu.tw/handle/123456789/526895Nicorandil is a vasodilatory drug used to relieve angina symptoms. Several healthcare products regulatory agencies have issued a warning associating the use of nicorandil and gastrointestinal (GI) ulceration. We aimed to evaluate the association between use of nicorandil and GI ulceration/perforation. A population-based cohort study involving 1 million randomly sampled participants in Taiwan? €? s National Health Insurance Research Database was carried out. We estimated the association between use of nicorandil and GI ulceration/perforation by a Cox proportional hazards regression model. A nicorandil-specific propensity score (PS) was also created for adjustment of 75 covariates and matching. 25.8% (183/710) of nicorandil-treated patients developed new GI ulcer events and 1.6% (20/1254) developed new GI perforation events in the three-year follow-up period, as compared to 9.3% (61,281/659,081) and 0.3% (2,488/770,537) in the general population comparator cohort. Patients treated with nicorandil were at significantly increased risk of GI ulcer (PS adjusted hazard ratio 1.43, 95% CI, 1.23 to 1.65, 6848 excess cases per 100,000 person years) or GI perforation (aHR 1.60, 95% CI 1.02-2.51, 315 excess cases per 100,000 person years) compared with the nicorandil unexposed population. Our finding may warn the clinicians to weigh the overall risk-benefit balance of nicorandil treatment in patients.[SDGs]SDG3nicorandil; adult; aged; chemically induced; human; intestine perforation; risk assessment; risk factor; stomach ulcer; Taiwan; time factor; treatment outcome; Adult; Aged; Humans; Intestinal Perforation; Nicorandil; Risk Assessment; Risk Factors; Stomach Ulcer; Taiwan; Time Factors; Treatment Outcomejournal article10.1038/srep11495261184312-s2.0-84934283938