title: Use of nicorandil is Associated with Increased Risk for Gastrointestinal Ulceration and Perforation- A Nationally Representative Population-based study.
abstract: Nicorandil 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.
authors.affiliation: 1] Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Department of Emergency Medicine and Department of General Medicine, National Taiwan University Hospital Yunlin Branch, Douliou, Taiwan.
authors.forename: Chien-Chang
authors.initials: CC
authors.lastname: Lee
authors.affiliation: 1] Department of Family Medicine, Chang Gung Memorial Hospital, Linkou, Taiwan [2] Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Shy-Shin
authors.initials: SS
authors.lastname: Chang
authors.affiliation: Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Shih-Hao
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Diagnostic Radiology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Yueh-Sheng
authors.initials: YS
authors.lastname: Chen
authors.affiliation: Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Wan-Ting
authors.initials: WT
authors.lastname: Hsu
authors.affiliation: Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Meng-Tse
authors.initials: MT
authors.lastname: Gabriel Lee
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D007416:Intestinal Perforation / Q000139:chemically induced*; D020108:Nicorandil / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D013276:Stomach Ulcer / Q000139:chemically induced*; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020108:Nicorandil