Effectiveness and safety of Lacosamide therapy for children with focal epilepsy: a real world study

Chunsong Yang; Zheng Liu; Yuxuan Peng; Lingli Zhang; Dan Yu

doi:10.3389/fphar.2023.1186768

Effectiveness and safety of Lacosamide therapy for children with focal epilepsy: a real world study

Front Pharmacol. 2023 Aug 9:14:1186768. doi: 10.3389/fphar.2023.1186768. eCollection 2023.

Authors

Chunsong Yang^{1

2

3

4}, Zheng Liu^{1

2

3

4

5}, Yuxuan Peng⁶, Lingli Zhang^{1

2

3

4

7}, Dan Yu^{4

8}

Affiliations

¹ Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
² Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.
³ NMPA Key Laboratory for Technical Research on Drug Products in Vitro and in Vivo Correlation, Chengdu, China.
⁴ Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.
⁵ West China School of Medicine, Sichuan University, Chengdu, China.
⁶ West China School of Pharmacy, Sichuan University, Chengdu, China.
⁷ Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
⁸ Department of Children's Genetic Endocrinology and Metabolism, West China Second University Hospital, Sichuan University, Chengdu, China.

Abstract

Objectives: To compare the effectiveness and safety of the new antiepileptic drug, lacosamide (LCM) with Levetiracetam, for the treatment of focal epilepsy in children. Methods: This study was a cohort study. Children with focal epilepsy who received LCM or Levetiracetam treatment in West China Second Hospital of Sichuan University were recruited and followed up for 12 months. Changes in the frequency of epilepsy, 50% and 75% responder rates, and seizure freedom rates from baseline to the maintenance period and adherence score were assessed. In addition, adverse events (AEs) were recorded. Results: 92 patients completed the study, and were divided into two groups: LCM (n = 46) and Levetiracetam (n = 46). Participants were aged from 2 to 16.3 years, with a mean epilepsy duration of 2.57 years. The average maintenance dose of LCM was 5.03 ± 1.91 mg/kg/d after the titration period. There was no significant difference between the two groups in terms of the mean seizure frequency during subsequent visits at 1, 3,6, 9, 12 months. There was significant difference between the two groups in terms of the 50% responder rate at 6 months. No serious AEs were reported in both groups. The vast majority of patients had good adherence (adherence score = 4) in the LCM group. Conclusion: LCM is effective as adjunctive therapy in children with epilepsy and has good safety, tolerability and adherence. Large sample size studies with long-term follow-up are needed in the future to comprehensively evaluate the use of LCM in children. Clinical Trial Registration: [https://www.chictr.org.cn/showproj.html?proj=41041], identifier [ChiCTR1900024507].

Keywords: children; effectiveness; focal-onset epilepsy; lacosamide; safety.

Grants and funding

This study was funded by Wu Jieping Medical Foundation from Chinese Medical Association Clinical Pharmaceutical Branch: Construction of medication adherence Nomogram Prediction Model for Childhood with Epilepsy and Intervention Strategies Based on Risk Stratification. The sponsor had no role in the study design, writing of the manuscript, or decision to submit this or future manuscripts for publication.