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

BACKGROUND

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.

METHODS

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 I2 index.

RESULTS

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.

CONCLUSION

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.