PCV145 ASSOCIATION BETWEEN NICORANDIL AND GASTROINTESTINAL ULCERS: A POPULATION-BASED STUDY

Abstract

The association between nicorandil (NCR) use, an antianginal drug, and the risk of gastrointestinal (GI) ulcers was evaluated in angina patients using Korean healthcare big data. A cross-sectional study was conducted using 2014 HIRA-NPS data including patients aged 40 years or more. A 3-month washout period was placed to identify new drug users and incident safety outcomes. A new NCR user was captured from a 3-month follow-up period followed by a 6-month period for detecting the safety outcome of GI ulcer. The association between NCR use and GI ulcers was evaluated using multivariate logistic regression analysis. The study population included 1,767 nicorandil users representing 58,900 Korean patients. Of the nicorandil users, 4,667 (8%) patients were reported to have one or more of GI ulcers as an adverse drug reactions (ADR). As compared to other anti-anginal medications including molsidomine, trimetazidine, nitrates, and calcium channel blockers, NCR was not found to increase the risk of GI ulcer (adjusted odds ratio [aOR] 1.119; 95% CI: 0.607 – 2.064) after adjusting confounders including age, sex, insurance type, and clinical comorbidities of diabetes, inflammatory bowel diseases, and any types of cancer. Among concurrent medications including corticosteroids, bisphosphonates, aspirin, anti-platelet agents, selective serotonin reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs), only corticosteroids (aOR 1.615; 95% CI: 1.124 – 2.319) and NSAIDs (aOR 1.776; 95% CI: 1.125 – 2.803) significantly increased the risk of GI ulcers. Using a 1-year real-world data available from the Korean healthcare insurance system, NCR did not significantly increase the risk of GI ulcers as compared to other anti-anginal medications. As the study only allowed a 6-month follow-up and the standard regimen did not exceed 15mg per day, which was lower than the ADR reported dosage of 60mg or higher, further research including longitudinal follow-ups and other real-world data are needed.