Lee Soo Hyeon, Sung Dae Hyeon, Cho Euna, Min Jeongah, Shin Sooyoung, Choi Yeo Jin
Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
Institute of Regulatory Innovation through Science (IRIS), Kyung Hee University, Seoul 02447, Republic of Korea.
Pharmaceuticals (Basel). 2025 Jul 7;18(7):1013. doi: 10.3390/ph18071013.
This study aims to comprehensively characterize the prevalence and severity of antiepileptic drug (AED)-induced adverse drug events (ADEs) and to identify predictors strongly associated with serious adverse events (SAEs) in both general and geriatric populations. This cross-sectional study investigated AED-related ADEs reported to the KIDS KAERS DB from January 2014 to December 2023. Disproportionality analysis was performed to detect the association between reported SAEs, and multiple logistic regression was conducted to identify predictors associated with SAEs. Cox's proportional hazard model was utilized to assess ADE duration in elderly patients aged 60 years and older. More than 50% of 36,809 AED-related ADEs were reported in elderly patients aged 60 years and older, and the prevalence of SAEs was 3.78%. ADEs associated with endocrine disorders had the highest likelihood of SAEs being reported (ROR 15.30), followed by hematological disorders. The predictors associated with elevated SAE risks in the elderly were male sex (OR 1.91; 95% CI 1.62-2.27), aging (OR 1.17; 95% CI 1.04-1.31), and certain AEDs. However, the concomitant administration of acid-suppressive therapy (AST) and opioids was associated with a lower risk of SAEs in the elderly population. Elderly patients not receiving concomitant AST were less likely to experience prolonged ADE duration (HR 0.28, 95% CI 0.07-1.15); however, no substantial differences in ADE duration were observed with the concomitant use of opioids. This study implies significant variability in the frequency, severity, and duration of ADEs depending on the type of AEDs, patient demographics, and concomitant medication use.
本研究旨在全面描述抗癫痫药物（AED）所致药物不良事件（ADE）的发生率和严重程度，并确定在普通人群和老年人群中与严重不良事件（SAE）密切相关的预测因素。这项横断面研究调查了2014年1月至2023年12月期间向儿童药物不良反应监测数据库（KIDS KAERS DB）报告的与AED相关的ADE。进行不成比例分析以检测报告的SAE之间的关联，并进行多元逻辑回归以确定与SAE相关的预测因素。采用Cox比例风险模型评估60岁及以上老年患者的ADE持续时间。在36809例与AED相关的ADE中，超过50%是60岁及以上老年患者报告的，SAE的发生率为3.78%。与内分泌疾病相关的ADE报告SAE的可能性最高（报告比值比为15.30），其次是血液系统疾病。老年人群中与SAE风险升高相关的预测因素为男性（比值比为1.91；95%置信区间为1.62 - 2.27）、年龄增长（比值比为1.17；95%置信区间为1.04 - 1.31）以及某些AED。然而，在老年人群中，同时使用抑酸治疗（AST）和阿片类药物与较低的SAE风险相关。未同时接受AST的老年患者发生ADE持续时间延长的可能性较小（风险比为0.28，95%置信区间为0.07 - 1.15）；然而，同时使用阿片类药物时，ADE持续时间未观察到显著差异。本研究表明，根据AED类型、患者人口统计学特征和同时使用的药物不同，ADE的频率、严重程度和持续时间存在显著差异。
