Effectiveness and safety of Lacosamide in pediatric patients with epilepsy under four years: Results from a prospective cohort study in China

作者全名：Xiong, Li; He, Huan; Wang, Duan; Liu, Tailin; Xiao, Nong

作者地址：[Xiong, Li; He, Huan; Wang, Duan; Liu, Tailin; Xiao, Nong] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Dept Rehabil, Minist Educ,Key Lab Child Dev & Disorders,Chongqin, 136 Zhongshan Er Rd, Chongqing 400000, Peoples R China

通信作者：Xiao, N (通讯作者)，Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Dept Rehabil, Minist Educ,Key Lab Child Dev & Disorders,Chongqin, 136 Zhongshan Er Rd, Chongqing 400000, Peoples R China.

来源：SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

ESI学科分类：NEUROSCIENCE & BEHAVIOR

WOS号：WOS:001232322300001

JCR分区：Q2

影响因子：2.7

年份：2024

卷号：118

期号：　

开始页：71

结束页：79

文献类型：Article

关键词：Pediatric; Lacosamide; Monotherapy; Adjunctive therapy; Retention rate; Response rate

摘要：Background: Lacosamide (LCM) has shown promising efficacy and safety outcomes in clinical trials. However, the evidence is limited among pediatric patients especially under four years in real -world. The study investigated the treatment outcomes and safety of LCM in patients under four years based on the data of the epilepsy registry of Children in China. Methods: A prospective cohort study was conducted among patients under 4 years who newly received LCM as monotherapy or adjunctive therapy. The treatment outcomes were measured by retention rate of LCM, 50 % response rates and seizure -free rates during follow-up. The retention rate of LCM was assessed using the KaplanMeier survival model. Adverse events were reported as a percentage of all participants. Results: Of 109 participants (mean follow-up: 18.6 months), 59 received LCM as monotherapy and 50 as adjunctive therapy. Sixty patients had focal epilepsy, 44 had generalized epilepsy and 5 had combined generalized and focal epilepsy. 70 % of patients in the monotherapy group and 41 % in the adjunctive therapy group remained on LCM treatment without additional treatments for at least one year. In patients with monotherapy, 50 % response rate and seizure -free rate were 75 % and 56 % at 12 months, respectively. In adjunctive therapy group, these rates were 51 % and 36 %, respectively. Lower baseline seizure frequency in both treatment groups (monotherapy: p < 0.001; adjunctive therapy: p = 0.02) and younger age groups within the monotherapy group ( P = 0.04) correlated with a higher LCM retention rate. Adverse events were reported by 15 patients (13.8 %), with somnolence being the most common (7 of 15 patients). Conclusion: With a comprehensive information and high -quality of data, the study demonstrates the effective treatment outcome and safety of LCM. The study adds reliable evidence to exiting real -word evidence of LCM in the specific age group of patients with epilepsy to fill the evidence gap.

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