Guedes Luís, Vieira Mariana, Gama Helena, Magano Daniel, Fernandes Maria, Calero Patricia, Di Foggia Valentina
BIAL-Portela & Cª., S.A., São Mamede do Coronado, Portugal.
Laboratorios Bial S.A., Madrid, Spain.
Epileptic Disord. 2023 Dec;25(6):803-814. doi: 10.1002/epd2.20146. Epub 2023 Aug 26.
Eslicarbazepine acetate (ESL) is a once-daily oral antiseizure medication. Its safety and tolerability from clinical trials have been mostly confirmed by real-world data. The main purpose of this report is to provide an overview of the safety profile of ESL in the United Kingdom (UK) and Republic of Ireland (ROI).
Safety data were obtained from the UK and ROI post-marketing sources (October 2009-April 2022) by the marketing authorization holder. All individual reports were included in the Argus Safety™ database. All adverse events (AEs) were coded using MedDRA® version 24.1. Only valid cases (meeting the minimum pharmacovigilance reporting requirements) were included.
During 13 years of ESL marketing, with cumulative estimated exposure of 2 210 395 patients-years, 183 reports were received. A total of 402 AEs were reported for the 155 valid reports. The most common reported AEs (≥6% of total reported), per system organ class (SOC), were: nervous system disorders (23.4%), injury, poisoning, and procedural complications (18.9%), general disorders and administration site conditions (12.9%), psychiatric disorders (12.7%) and gastrointestinal disorders (6.7%). The most frequently reported (≥2% of total reported) AEs were: seizure (4.5%), hyponatremia (4.2%), dizziness (2.7%), rash, fatigue (2.5% each), and somnolence (2.0%). Twenty-six percent of events were classified as serious (including six fatal cases).
The current analysis supports the known safety profile of ESL, as generally well-tolerated with most AEs being non-serious. The most common AEs were considered either expected according to the disease itself or to the reference safety information. ESL continues to be a relevant medication in the treatment of partial (focal-onset) epilepsy, as also confirmed by the 2022 NICE guidelines.
醋酸艾司卡比西平（ESL）是一种每日服用一次的口服抗癫痫药物。其在临床试验中的安全性和耐受性大多已得到真实世界数据的证实。本报告的主要目的是概述ESL在英国和爱尔兰共和国的安全性概况。
上市许可持有人从英国和爱尔兰共和国的上市后来源（2009年10月至2022年4月）获取安全数据。所有个体报告均纳入阿格斯安全™数据库。所有不良事件（AE）均使用MedDRA®24.1版进行编码。仅纳入有效病例（符合最低药物警戒报告要求）。
在ESL上市的13年中，累计估计暴露量为2210395患者年，共收到183份报告。155份有效报告中共报告了402例AE。按系统器官分类（SOC），最常报告的AE（占报告总数的≥6%）为：神经系统疾病（23.4%）、损伤、中毒和操作并发症（18.9%）、全身疾病和给药部位状况（12.9%）、精神疾病（12.7%）和胃肠道疾病（6.7%）。最常报告的AE（占报告总数的≥2%）为：癫痫发作（4.5%）、低钠血症（4.2%）、头晕（2.7%）、皮疹、疲劳（各2.5%）和嗜睡（2.0%）。26%的事件被分类为严重事件（包括6例死亡病例）。
当前分析支持ESL已知的安全性概况，即总体耐受性良好，大多数AE为非严重事件。大多数常见AE被认为是根据疾病本身或参考安全信息所预期的。ESL仍然是治疗部分性（局灶性发作）癫痫的一种相关药物，2022年英国国家卫生与临床优化研究所（NICE）指南也证实了这一点。
