Comparative Risk for Neuropsychiatric Events in Leukotriene Receptor Antagonist vs. Inhaled Corticosteroid in Children With Asthma: A Nationwide Observational Study With a Complementary Analysis Using Natural Language Processing.
Subin Kim, Chang Hoon Han, Junhyuk Chang, Jaehyeong Cho, Kyunguk Jeong, Hamin Kim, Mireu Park, Soo Yeon Kim, Jong Deok Kim, Myung Hyun Sohn, Sooyoung Lee, Rae Woong Park, Seng Chan You, Kyung Won Kim
{"title":"Comparative Risk for Neuropsychiatric Events in Leukotriene Receptor Antagonist vs. Inhaled Corticosteroid in Children With Asthma: A Nationwide Observational Study With a Complementary Analysis Using Natural Language Processing.","authors":"Subin Kim, Chang Hoon Han, Junhyuk Chang, Jaehyeong Cho, Kyunguk Jeong, Hamin Kim, Mireu Park, Soo Yeon Kim, Jong Deok Kim, Myung Hyun Sohn, Sooyoung Lee, Rae Woong Park, Seng Chan You, Kyung Won Kim","doi":"10.1002/pds.70254","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Leukotriene receptor antagonists (LTRAs) are widely prescribed as controller medications for pediatric asthma. However, there have been increasing concerns about potential neuropsychiatric adverse reactions associated with LTRAs. Findings from observational studies have been inconsistent, and direct comparisons of the risk of neuropsychiatric events (NPEs) between LTRAs and inhaled corticosteroids (ICS) remain limited in the pediatric population.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted utilizing a nationwide claims database (January 2018-April 2022) and a multicenter electronic health record (EHR) database (January 2006-March 2022) from South Korea. Patients aged 5-18 years diagnosed with asthma before initiating LTRA or ICS were included. The primary outcome was NPEs within 90 days of exposure, defined using two methods: diagnostic code-based analysis and natural language processing (NLP)-based analysis using clinical notes. After propensity score stratification, Cox proportional hazards models were used to estimate risks.</p><p><strong>Results: </strong>The diagnostic code-based analysis on the claims database included 169 636 LTRA users and 28 845 ICS users. There was no statistically significant difference in the risk of NPEs between LTRA and ICS (calibrated hazard ratios [HRs], 1.14 [95% CI, 0.92-1.42]). In the NLP-based analysis using EHR database, 1641 LTRA users and 1607 ICS users were included. The results were consistent with those of the diagnostic code-based analysis (calibrated HR, 1.33 [95% CI, 0.66-2.68]).</p><p><strong>Conclusions: </strong>LTRA use was not found to be associated with a significantly increased risk of NPEs in children with asthma. These findings offer valuable insights to support clinical decision-making in pediatric asthma treatment.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70254"},"PeriodicalIF":2.4000,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12575417/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70254","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: Leukotriene receptor antagonists (LTRAs) are widely prescribed as controller medications for pediatric asthma. However, there have been increasing concerns about potential neuropsychiatric adverse reactions associated with LTRAs. Findings from observational studies have been inconsistent, and direct comparisons of the risk of neuropsychiatric events (NPEs) between LTRAs and inhaled corticosteroids (ICS) remain limited in the pediatric population.
Methods: A retrospective cohort study was conducted utilizing a nationwide claims database (January 2018-April 2022) and a multicenter electronic health record (EHR) database (January 2006-March 2022) from South Korea. Patients aged 5-18 years diagnosed with asthma before initiating LTRA or ICS were included. The primary outcome was NPEs within 90 days of exposure, defined using two methods: diagnostic code-based analysis and natural language processing (NLP)-based analysis using clinical notes. After propensity score stratification, Cox proportional hazards models were used to estimate risks.
Results: The diagnostic code-based analysis on the claims database included 169 636 LTRA users and 28 845 ICS users. There was no statistically significant difference in the risk of NPEs between LTRA and ICS (calibrated hazard ratios [HRs], 1.14 [95% CI, 0.92-1.42]). In the NLP-based analysis using EHR database, 1641 LTRA users and 1607 ICS users were included. The results were consistent with those of the diagnostic code-based analysis (calibrated HR, 1.33 [95% CI, 0.66-2.68]).
Conclusions: LTRA use was not found to be associated with a significantly increased risk of NPEs in children with asthma. These findings offer valuable insights to support clinical decision-making in pediatric asthma treatment.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
