# Safety and Efficacy of Eslicarbazepine Acetate in Children Diagnosed With a Focal Seizure Disorder: A Systematic Review and Meta‐Analysis

## TL;DR

This study evaluates the safety and effectiveness of eslicarbazepine acetate in children with focal seizures, finding it reduces seizures but increases some side effects.

## Contribution

A systematic review and meta-analysis of ESL's safety and efficacy in children with focal seizures, revealing both benefits and risks.

## Key findings

- ESL significantly reduced seizure frequency compared to placebo.
- ESL was associated with increased risks of specific adverse events like somnolence and diplopia.
- Most adverse events were mild to severe, with higher discontinuation rates in ESL-treated children.

## Abstract

Epilepsy can have a negative impact on cognitive and social functioning. Eslicarbazepine acetate (ESL) is used to treat focal seizures, although its safety and efficacy, particularly as an additional treatment, warrant more study. The purpose of this study was to evaluate the safety and efficacy of ESL in children with focal seizures by analyzing data from relevant clinical trials.

This study was conducted in line with the PRISMA guidelines and has been registered on the PROSPERO 2024 CRD42024569119 register. A detailed search up to July 2024 through Cochrane CENTRAL, PubMed/MEDLINE, and Google Scholar was conducted for the studies comparing ESL with placebo. For the meta‐analysis, the Mantel–Haenszel random‐effects model was applied, and heterogeneity was measured using the I
2 index.

The study included a total of 742 children from the randomized controlled trials; of these, 414 were given ESL, whereas 328 were given a placebo. ESL significantly reduced seizure frequency when compared to placebo (SMD = −0.29; 95% CI [−0.57, −0.02]). Nevertheless, it has been related to a greater risk of side effects, including headaches, sleepiness, nausea, vomiting, double vision, and dizziness. Adverse events were measured to evaluate clinical significance. Treatment‐emergent‐related adverse events (TEAEs) occurred in 52.2% of ESL‐treated participants versus 49.1% in placebo individuals (RR = 1.08; 95% CI [0.96–1.20]; p = 0.20), indicating no statistically significant increase overall. However, specific adverse events were significantly more common with ESL, including somnolence: RR = 1.95; 95% CI (1.11–3.43); p = 0.02 and diplopia: RR = 4.34; 95% CI (1.60–11.78); p = 0.004. Other common but nonsignificant adverse events included headache (11.49%), vomiting (6.15%), nausea (3.34%), and dizziness (3.2%). Adverse event‐related treatment discontinuation was reported in 5.2%–5.9% of ESL patients compared to 2.3%–2.5% of placebo patients. Most adverse events were mild to severe, although serious adverse events (e.g., status epilepticus, device‐related problems) were more common in the ESL group.

Though ESL increases the risk of adverse effects, it dramatically reduces seizure frequency in children with focal epilepsy. These risks require regular monitoring. Subsequent study should focus on long‐term effectiveness, safety, and ways to mitigate the negative effects of ESL.