In this study, clinical manifestations of adverse events and frequently used medications in patients receiving parenteral nutrition (PN) in Korea were evaluated using Korea Adverse Event Reporting System (KAERS) database records between 2011 and 2015. Amino acids, fat emulsions, carbohydrates, combinations and solutions for PN were identified as causative agents. Adverse events classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Centre criteria were analysed. In total, 6439 adverse events from 4260 patients were included for analysis. Mean patient age was 54.4 ± 18.1 years and the mean number of adverse events per patient was 1.5 ± 1.1. Frequent adverse events were gastrointestinal (2159 events, 33.5%), skin/appendage (1344 events, 20.9%), general (846 events, 13.1%) and central/peripheral nervous system (716 events, 11.1%) disorders. Common clinical symptoms were nausea (1248 events, 19.4%), vomiting (558, 8.7%), pruritus (456 events, 7.1%), rash (386 events, 6.0%) and dizziness (329 events, 5.1%). The frequently reported concomitant agents were tramadol (n = 475, 3.1%), fentanyl (n = 405, 2.7%), paracetamol (n = 329, 2.2%), ketorolac (n = 322, 2.1%) and metoclopramide (n = 289 cases, 1.9%). The frequent adverse events remained consistent after accounting for concurrent medications. Our findings from a nationwide reporting system database found that gastrointestinal disorders (nausea and vomiting) were the leading adverse events, requiring further studies on their prevalence, mechanisms and therapeutic options.
Objectives The purpose of this study was to investigate the effect of sulfonylureas (SUs) and antimicrobial co‐administration on hypoglycemia in patients with type 2 diabetes mellitus (T2DM). Methods We conducted a case‐crossover study using the Korean Health Insurance Review and Assessment Service‐National Inpatient Sample database, using data from 2014 to 2016. Hospitalized adult patients with T2DM who were diagnosed with hypoglycemia and prescribed SUs for at least 120 days were included. Different risk ratings of severity of drug–drug interactions were considered, including “level X, D, or C” in Lexi‐Interact online and “contraindicated, major, or moderate” in Micromedex. Exposure to antimicrobials in the 30‐day period before the first hypoglycemia diagnosis was assessed. Two control periods (61–90 and 91–120 days) were matched before the diagnosis date. Conditional logistic regression analysis was conducted to compare the odds of antimicrobial exposure. Results A total of 9339 patients were included. The mean age of the patients was 71.3 ± 10.6 years, and 4818 (51.6%) were women. An increased risk of hypoglycemia was associated with co‐administration of SUs and certain antimicrobials (adjusted odds ratio [aOR] 2.56, 95% confidence interval [CI] 2.34–2.80). The antimicrobial agents that were associated with an increased risk of hypoglycemia, when co‐administered with SUs, were sulfonamides (aOR 2.99, 95% CI 1.99–4.52), fluoroquinolones (aOR 2.62, 95% CI 2.38–2.89), macrolides (aOR 2.48, 95% CI 1.88–3.27), and tetracyclines (aOR 1.56, 95% CI 1.05–2.33). Conclusions Co‐administration with SUs and certain antimicrobials increased the risk of hypoglycemia. Thus, clinically relevant interactions in patients concurrently using SUs and antimicrobials should be monitored, especially within 30 days after co‐administration.
Diabetes mellitus (DM) is a common chronic metabolic disease.According to the World Health Organization, the number of patients with DM aged 20 years and above was 422 million in 2014 and is expected to reach 643 million in 2030 and 783 million in 2045. 1,2 The prevalence of DM in Korea has also increased in recent years. According to the diabetes fact sheet of the Korean Diabetes Association in 2020, 13.8% of adults aged 30 years or older had DM. In particular, the prevalence of DM in the elderly,
Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ≤75 with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ≥7.5% estimated 10-year ASCVD risk and LDL-C ≥190 mg/ dL. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate-to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate-to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (≥18 years) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate-to lowintensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG (67 ± 14 vs 62 ± 12). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.
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