Use of lacosamide in children: experience of a tertiary medical care center in Brazil

Abstract

Background Lacosamide (LCM) is a third-generation anti-seizure drug approved in Europe and the United States, either as a monotherapy or adjunctive therapy, to treat partial-onset seizures in adults, adolescents, and children. In Brazil, LCM is licensed for treatment only in patients older than 16 years of age. Objective To evaluate a cohort of children presenting with refractory epilepsy who received LCM as an add-on therapy and observe the response and tolerability to the LCM treatment. Methods A retrospective cohort study conducted in a tertiary health care facility, which included 26 children, aged up to 16 years, who presented with refractory epilepsy and received LCM as an add-on treatment. The follow-up visits were scheduled every 3 months until 9 months of treatment with LCM. Results After 3 months of LCM administration, in 73.1% of the children, there was a reduction of > 50% in the frequency of seizures, and this clinical improvement was maintained in most patients (73.9%) for the following 9 months. Mild (such as, somnolence and behavioral changes) or severe (seizure worsening) adverse effects were observed in two and three children respectively. Among responders to LCM, there was a higher prevalence of males, fewer concomitant anti-seizure drugs, and lower percentage of patients using sodium channel blockers. Conclusions Lacosamide should be considered as an early treatment option in pediatric patients with refractory epilepsy, mainly focal seizures.

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

“…In 2022, Romão et al, 2022 conducted a retrospective cohort study in a tertiary healthcare facility in Brazil, which included 26 children with refractory epilepsy, and found the reduction of >50% in the frequency of seizures was 73.1% and 73.9% after 3 months and 9 months of LCM treatment, mild AEs were observed in very few children. In 2016, a large double-blind randomized controlled trial revealed that the average 4-week frequency of seizure episodes during the maintenance period with the use of 200 and 400 mg/day of LCM decreased by 29.4% and 39.6% in Chinese and Japanese adults, respectively, and the most common AEs were dizziness and drowsiness.…”

“…Compared with the previous studies, the responder rate for LCM and the percentage reduction in seizure frequency per 28 days were higher in our study, this may be because our subjects were not refractory epilepsy, and seizures were not very frequent (the number of seizure was less than 5 at baseline during 4 weeks) at the time of inclusion in the study. In addition, the above research included refractory epilepsy ( Feng et al, 2020 ; Romão et al, 2022 ), so the effect of drug control may be different in different types of epilepsy. In addition, the duration of the epilepsy time were 4.8 ± 3.4 and 4.49 ± 2.34, respectively ( Feng et al, 2020 ; Romão et al, 2022 ), which was longer than that in our study, so this may be also one of the reasons for the differences in effectiveness.…”

“…In addition, the above research included refractory epilepsy ( Feng et al, 2020 ; Romão et al, 2022 ), so the effect of drug control may be different in different types of epilepsy. In addition, the duration of the epilepsy time were 4.8 ± 3.4 and 4.49 ± 2.34, respectively ( Feng et al, 2020 ; Romão et al, 2022 ), which was longer than that in our study, so this may be also one of the reasons for the differences in effectiveness. There are few studies comparing LCM and Levetiracetam in the treatment of focal epilepsy in children.…”