IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy(2).
Centro Epilessia, UOC Neurologia AULSS 8, Vicenza, Italy.
Seizure. 2021 Feb;85:26-38. doi: 10.1016/j.seizure.2020.12.005. Epub 2020 Dec 21.
Following recent European Medication Agency restrictions on valproate (VPA) use in girls and women of childbearing potential (WOCP), the Commission on Epilepsy and Gender of the Italian League against Epilepsy integrated current literature and legislative data in order to provide clinicians with guidance on antiseizure medication (ASM) prescription for Idiopathic Generalized Epilepsies (IGEs) in this population, avoiding VPA. We reviewed the updated literature on ASMs and examined the teratogenicity of those showing efficacy in IGEs. For all relevant ASMs, we considered the indications for use and the pregnancy and contraception-related recommendations given in the Italian Summary of Product Characteristics (SmPC) and on the websites of the European Medicines Agency (EMA) and other European Union (EU) countries' regulatory agencies. With the exception of absence seizures, the literature lacks high quality studies on ASMs in IGEs. In girls and WOCP, levetiracetam and lamotrigine should be considered the first-choice drugs in Generalized Tonic-Clonic Seizures Alone and in Juvenile Myoclonic Epilepsy, lamotrigine in Juvenile Absence Epilepsy, and ethosuximide in Childhood Absence Epilepsy. Although supported by the literature, several ASMs are off label, contraindicated or burdened by special warnings in pregnancy. Some discrepancies emerged between the various SmPC warnings for different brands of the same active principle. We provided a therapeutic algorithm for each IGE syndrome and highlighted the need for revised prescription rules, consistent with the latest literature data, uniformity of SmPC warnings for the same active principle, and more data on the efficacy of new ASMs in IGEs and their safety in pregnancy.
继欧洲药品管理局最近对有生育潜能的女童和妇女使用丙戊酸盐(VPA)的限制后,意大利癫痫联盟癫痫与性别委员会整合了当前的文献和立法数据,以便为临床医生提供在避免使用 VPA 的情况下,为该人群中的特发性全面性癫痫(IGE)开具抗癫痫药物(ASM)的指导。我们回顾了关于 ASM 的最新文献,并研究了那些在 IGE 中显示疗效的药物的致畸性。对于所有相关的 ASM,我们考虑了意大利产品特性摘要(SmPC)和欧洲药品管理局(EMA)以及其他欧盟国家监管机构网站上给出的使用说明以及与妊娠和避孕相关的建议。除了失神发作外,文献中缺乏关于 IGE 中 ASM 的高质量研究。对于女孩和有生育潜能的妇女,左乙拉西坦和拉莫三嗪应被视为单独全面强直阵挛发作和青少年肌阵挛性癫痫的首选药物,拉莫三嗪应被视为青少年失神性癫痫的首选药物,乙琥胺应被视为儿童失神性癫痫的首选药物。尽管有文献支持,但有几种 ASM 是超说明书使用、禁忌或在妊娠期间有特殊警告。同一活性成分的不同 SmPC 警告之间存在一些差异。我们为每个 IGE 综合征提供了治疗算法,并强调需要根据最新文献数据修订处方规则,使同一活性成分的 SmPC 警告一致,并提供更多关于新 ASM 在 IGE 中的疗效及其在妊娠中的安全性的数据。