Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea.

INTRODUCTION: Angiotensin receptor blockers are widely used antihypertensive drugs in South Korea. In 2021, the Korea Ministry of Food and Drug Safety acknowledged the need for national compensation for a drug-induced liver injury (DILI) after azilsartan use. However, little is known regarding the association between angiotensin receptor blockers and DILI. OBJECTIVE: We conducted a retrospective cohort study in incident users of angiotensin receptor blockers from a common data model database (1 January, 2017-31 December, 2021) to compare the risk of DILI among specific angiotensin receptor blockers against valsartan. METHODS: Patients were assigned to treatment groups at cohort entry based on prescribed angiotensin receptor blockers. Drug-induced liver injury was operationally defined using the International DILI Expert Working Group criteria. Cox regression analyses were conducted to derive hazard ratios and the inverse probability of treatment weighting method was applied. All analyses were performed using R. RESULTS: In total, 229,881 angiotensin receptor blocker users from 20 university hospitals were included. Crude DILI incidence ranged from 15.6 to 82.8 per 1000 person-years in treatment groups, most were cholestatic and of mild severity. Overall, the risk of DILI was significantly lower in olmesartan users than in valsartan users (hazard ratio: 0.73 [95% confidence interval 0.55-0.96]). In monotherapy patients, the risk was significantly higher in azilsartan users than in valsartan users (hazard ratio: 6.55 [95% confidence interval 5.28-8.12]). CONCLUSIONS: We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice.

Risk of aortic aneurysm and aortic dissection with the use of fluoroquinolones in Korea: a nested case-control study.

BACKGROUND: Recent studies have raised concern about the association of fluoroquinolones with an increased risk of aortic aneurysm and aortic dissection. We aimed to evaluate such risk in a Korean population. METHODS: We conducted a nested case-control study using data from the National Health Insurance Service collected from 2013 to 2017 in Korea. The study cohort included patients older than 40 years and excluded patients who had used fluoroquinolones or been diagnosed with aortic aneurysm, aortic dissection, or related diseases 1 year prior to the cohort entry date. We randomly matched four controls in the risk set with each case of aortic aneurysm and aortic dissection (same sex, age, and cohort entry date). We assessed the risk of aortic aneurysm and aortic dissection from fluoroquinolones and adjusted for potential confounders using a conditional logistic regression model. RESULTS: A total of 29,638 aortic aneurysm and aortic dissection patients were identified between 2014 and 2017. The use of fluoroquinolones within a year was associated with a 10% increased risk of aortic aneurysm and aortic dissection (adjusted odds ratio: 1.10, 95% CI 1.07-1.14, p < 0.05) compared with nonusers. The risk was higher in patients who had used fluoroquinolones within 60 days (adjusted odds ratio: 1.53, 95% CI 1.46-1.62, p < 0.05). The risk of aortic aneurysm and aortic dissection positively correlated with the cumulative dose and duration of fluoroquinolone therapy (p < 0.001). CONCLUSIONS: Our study provides real-world evidence of the risk of aortic aneurysm and aortic dissection from fluoroquinolones in Korea. Patients and medical professionals should be aware that fluoroquinolones can increase the risk of aortic aneurysm and aortic dissection, which may be acerbated by high dosage and duration of use.

Korean Pharmacovigilance System Based on EHR-CDM.

An electronic health record (EHR) contains various clinical information for pharmacovigilance studies, but they remain difficult to use. From 2016 to 2018, the ministry of food and drug safety and Korea institute of drug safety & risk management (KIDS) converted the EHRs of more than 9 million patients to a MOA common data model (CDM). KIDS developed the Medical record observation and assessment for drug safety network (MOA-Net), a web portal site to build a network between CDM data partners. Through MOA-Net, hospitals participated in pharmacovigilance studies and confirmed the usability and adequacy of the CDM.

A Diabetes-Related Dietary Pattern Is Associated with Incident Diabetes in Obese Men in the Korean Genome Epidemiology Study.

BACKGROUND: Diet plays an important role in both the development and management of diabetes. OBJECTIVE: Using data from the Korean Genome Epidemiology Study, we assessed dietary patterns associated with the clinical indicators of diabetes. METHODS: This study included 7255 subjects aged 40-69 y. Individuals with chronic diseases were excluded. The daily intakes of specific food items were assessed using a dish-based semiquantitative food-frequency questionnaire comprising 103 items; the food items were then grouped into 26 food groups. Dietary patterns were analyzed by the reduced rank regression method using glycated hemoglobin, the homeostasis model of insulin resistance, and fasting glucose concentrations as dependent variables. We investigated the associations between dietary patterns and incident diabetes using the Cox proportional hazards model. RESULTS: During an 11.5-y follow-up, the incidence of diabetes was 11.8/1000 person-years. The dietary pattern related to selected biomarkers of diabetes was characterized by a relatively high intake of kimchi, beef, other meat, fish, and coffee in men and a high intake of rice, kimchi, and fruit in women. In men, the association of dietary patterns with incident diabetes was significant only in the obese group, and those in the top quartile of the dietary pattern score had a 1.72 times (95% CI: 1.15, 2.56 times) greater risk of incident diabetes than those in the bottom quartile. Conversely, dietary patterns in women were not associated with incident diabetes. CONCLUSION: Using reduced rank regression, we identified dietary patterns related to selected biomarkers of diabetes in a long-term study with follow-up data in Korea.