OBJECTIVE Several publications on the exchangeability of antiepileptic drugs in clinical settings revealed an increased risk for seizure recurrence after changing the manufacturer of anti-seizure drugs (ASD) in adults, possibly due to a decline of adherence. It is unclear whether this holds true in children and adolescents. METHODS Patient data of children and adolescents (<18 years) were collected anonymously from 236 German pediatricians and pediatric neurologists between January 2011 and December 2018 using the IMS® Disease Analyzer database (IQVIA, Frankfurt, Germany). Patients with epilepsy were included if at least 2 prescriptions within 360 days and 1 within 180 days prior to the index date were available. The cohort was separated into a seizure group and seizure-free controls. Both groups were matched 1:1 according to age, gender, insurance status, and treating pediatrician. The risk for seizure recurrence after a manufacturer switch of the same ASD at the last prescription before the index date was analyzed using a multivariate regression model. RESULTS A total of 678 children and adolescents with epilepsy were included (each group: n = 339; age: 9.6 ± 4.4 years). Comparing both groups, the risk for seizures recurrence was not increased after a manufacturer switch had occurred. Albeit changes during the last prescription before the index date had occurred more often in the seizure-free group, neither change of branded and generic products nor substances reached significance. Only change of ASD strength showed a significantly reduced odds ratio for seizures (OR 0.40, 95% CI 0.24-0.65, p < 0.001). SIGNIFICANCE In contrast to the available evidence in adults, changing the manufacturer did not appear to increase the risk for seizure recurrence in previously seizure-free children and adolescents with epilepsy.

中文翻译：

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抗癫痫药物的制造商转换可能不会增加儿童癫痫复发的风险：德国处方数据的全国性研究

目标 一些关于临床环境中抗癫痫药物可交换性的出版物显示，在成人更换抗癫痫药物 (ASD) 制造商后，癫痫复发的风险增加，这可能是由于依从性下降。目前尚不清楚这是否适用于儿童和青少年。方法 2011 年 1 月至 2018 年 12 月期间，使用 IMS® 疾病分析仪数据库（IQVIA，德国法兰克福）匿名收集了 236 名德国儿科医生和儿科神经科医生的儿童和青少年（<18 岁）患者数据。如果在索引日期前 360 天内至少有 2 个处方，并且在 180 天内至少有 1 个处方可用，则包括癫痫患者。该队列被分成癫痫发作组和无癫痫发作的对照组。两组按年龄、性别、保险状况和治疗儿科医生。使用多元回归模型分析在索引日期之前的最后一次处方中制造商更换相同 ASD 后癫痫复发的风险。结果 共纳入 678 名癫痫儿童和青少年（每组：n = 339；年龄：9.6 ± 4.4 岁）。比较两组，发生制造商转换后癫痫复发的风险并未增加。尽管在无癫痫发作组中，索引日期前最后一次处方的变化发生得更频繁，但品牌和非专利产品或物质的变化都没有达到显着意义。只有 ASD 强度的变化显示癫痫发作的比值比显着降低（OR 0.40，95% CI 0.24-0.65，p < 0.001）。意义 与成人中的现有证据相比，