Institute of Neurology IRCCS C. Mondino Foundation, University of Pavia, Pavia, Italy.
Neurology. 2011 Jan 18;76(3):273-9. doi: 10.1212/WNL.0b013e318207b073.
Adverse effects (AEs) are a major concern when starting antiepileptic drug (AED) treatment. This study quantified the extent to which AE reporting in people with new-onset seizures started on AEDs is attributable to the medication per se, and investigated variables contributing to AE reporting.
We pooled data from 2 large prospective studies, the Multicenter Study of Early Epilepsy and Single Seizures and the Northern Manhattan Study of incident unprovoked seizures, and compared adverse event profile (AEP) total and factor scores between adult cases prescribed AEDs for new-onset seizures and untreated controls, adjusting for several demographic and clinical variables. Differences in AEP scores were also tested across different AED monotherapies and controls, and between cases and controls grouped by number of seizures.
A total of 212 cases and 206 controls were identified. Most cases (94.2%) were taking low AED doses. AEP scores did not differ significantly between the 2 groups. Depression, female gender, symptomatic etiology, younger seizure onset age, ≥2 seizures, and history of febrile seizures were associated with higher AEP scores. There were no significant differences in AEP scores across different monotherapies and controls. AEP scores increased in both cases and controls with increasing number of seizures, the increment being more pronounced in cases.
When AED treatment is started at low doses following new-onset seizures, AE reporting does not differ from untreated individuals. Targeting specific factors affecting AE reporting could lead to improved tolerability of epilepsy treatment.
抗癫痫药物(AED)治疗起始时的不良反应(AE)是一个主要关注点。本研究量化了新诊断癫痫发作患者开始使用 AED 治疗时 AE 报告归因于药物本身的程度,并调查了导致 AE 报告的变量。
我们汇总了两项大型前瞻性研究(多中心早期癫痫和单发性癫痫研究以及北部曼哈顿发作性无诱因癫痫研究)的数据,并比较了新诊断癫痫发作患者处方 AED 与未治疗对照者的不良事件谱(AEP)总分和因子评分,调整了多个人口统计学和临床变量。我们还比较了不同 AED 单药治疗和对照组以及按发作次数分组的病例和对照组之间的 AEP 评分差异。
共纳入 212 例病例和 206 例对照者。大多数病例(94.2%)服用低剂量 AED。两组 AEP 评分无显著差异。抑郁、女性、症状性病因、起病年龄较小、≥2 次发作和热性惊厥史与 AEP 评分较高相关。不同单药治疗和对照组之间的 AEP 评分无显著差异。随着发作次数的增加,病例和对照组的 AEP 评分均增加,病例的增加更为明显。
新诊断癫痫发作患者开始低剂量 AED 治疗时,AE 报告与未治疗个体无差异。针对影响 AE 报告的特定因素可能会提高癫痫治疗的耐受性。