BACKGROUND AND OBJECTIVES Systematic screening can help identify antiseizure medication (ASM)-associated adverse events (AEs) that may preclude patients from reaching effective doses or completing adequate trial periods. The Adverse Event Profile (AEP) is a self-completed instrument to identify the frequency of common AEs associated with ASM use. This study aimed to compare the AE profile of commonly used ASMs in adults with newly diagnosed focal epilepsy. METHODS The Human Epilepsy Project is a prospective, international, observational study investigating markers of treatment response in newly diagnosed focal epilepsy. Participants were enrolled within 4 months of treatment initiation. Adult participants on levetiracetam, lamotrigine, carbamazepine, or oxcarbazepine monotherapy who completed the AEP and Mini International Neuropsychiatric Interview at enrollment were included. Multivariable generalized linear and penalized logistic regression models assessed differences in total and itemized marginal AEP scores and dichotomized responses ("never/rarely" vs "sometimes/always"). RESULTS A total of 225 adults initiated on levetiracetam (n = 132, 59%), lamotrigine (n = 55, 24%), carbamazepine (n = 19, 8.4%), or oxcarbazepine (n = 19, 8.4%) were included. There were no significant differences in AEP total scores between ASMs. Patients with depression (adjusted marginal score ratio [aMSR] 1.23, 95% CI 1.09-1.39, p = 0.001) and anxiety (aMSR 1.15, 95% CI 1.04-1.26, p = 0.007) had worse AEP total scores than those without. After adjusting for depression and anxiety, levetiracetam users were >3 times more likely to report feelings of aggression (adjusted odds ratio [aOR] 3.38, 95% CI 1.07-10.7, p = 0.038) and almost half as likely to experience unsteadiness (aOR 0.45, 95% CI 0.21-0.99, p = 0.047) than lamotrigine users. Carbamazepine and oxcarbazepine had the highest rates of discontinuation (42.1%, each), followed by levetiracetam (34.8%) and lamotrigine (16.4%). Levetiracetam users had the highest proportion of discontinuations because of AEs alone (18%), and lamotrigine had the lowest (5%). DISCUSSION Systematic screening for AEs in adults with newly diagnosed focal epilepsy on ASM monotherapy showed that those with comorbid psychiatric conditions report greater AEs overall, irrespective of ASM. Levetiracetam was associated with >3-fold risk of psychiatric AEs and half the risk of experiencing unsteadiness than lamotrigine. Levetiracetam had the highest proportion of discontinuations because of AEs alone, while lamotrigine had the lowest.

中文翻译：

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常用抗癫痫药物对新诊断的局灶性癫痫成人的不良影响。


背景和目标 系统筛查可以帮助识别抗癫痫药物 (ASM) 相关的不良事件 (AE)，这些不良事件可能会妨碍患者达到有效剂量或完成足够的试验期。不良事件概况 (AEP) 是一种自行完成的工具，用于识别与 ASM 使用相关的常见 AE 的频率。本研究旨在比较新诊断局灶性癫痫成人中常用 ASM 的 AE 情况。方法人类癫痫项目是一项前瞻性、国际性观察性研究，旨在调查新诊断的局灶性癫痫的治疗反应标志物。参与者在治疗开始后 4 个月内入组。接受左乙拉西坦、拉莫三嗪、卡马西平或奥卡西平单药治疗并在入组时完成 AEP 和小型国际神经精神访谈的成年参与者均被纳入其中。多变量广义线性和惩罚逻辑回归模型评估了总和逐项边际 AEP 分数以及二分反应（“从不/很少”与“有时/总是”）的差异。结果 共有 225 名成人开始服用左乙拉西坦 (n = 132, 59%)、拉莫三嗪 (n = 55, 24%)、卡马西平 (n = 19, 8.4%) 或奥卡西平 (n = 19, 8.4%) 。 ASM 之间的 AEP 总分没有显着差异。患有抑郁症（调整后的边际评分比 [aMSR] 1.23，95% CI 1.09-1.39，p = 0.001）和焦虑症（aMSR 1.15，95% CI 1.04-1.26，p = 0.007）的患者的 AEP 总分比没有抑郁症的患者差。在调整抑郁和焦虑后，左乙拉西坦使用者报告攻击性感觉的可能性增加了 3E3 倍（调整后优势比 [aOR] 3.38，95% CI 1.07-10.7，p = 0.038），并且经历不稳定的可能性几乎是一半（aOR） 0。45，95% CI 0.21-0.99，p = 0.047）高于拉莫三嗪使用者。卡马西平和奥卡西平的停药率最高（各 42.1%），其次是左乙拉西坦（34.8%）和拉莫三嗪（16.4%）。左乙拉西坦使用者仅因 AE 而停药的比例最高 (18%)，拉莫三嗪最低 (5%)。讨论 对接受 ASM 单药治疗的新诊断局灶性癫痫成人患者进行的 AE 系统筛查显示，无论是否采用 ASM，患有合并精神疾病的患者总体上报告的 AE 较多。与拉莫三嗪相比，左乙拉西坦的精神 AE 风险为 3E3 倍，不稳定风险为一半。左乙拉西坦仅因 AE 停药的比例最高，而拉莫三嗪最低。