Epilepsy research · 2025
The effectiveness and safety of lacosamide in infants with epilepsy aged under 2 years: A prospective study.
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Tailin Liu, Li Xiong, Jing Liu, Jiayi Wang, Nong Xiao
Аннотация
OBJECTIVE: To evaluate the effectiveness and safety of lacosamide (LCM) in children with epilepsy aged 1 month to 2 years, including those with developmental epileptic encephalopathy (DEE), and to identify risk factors influencing effectiveness.
METHODS: This single-center prospective cohort study enrolled children who received LCM as monotherapy or adjunctive therapy at Children's Hospital of Chongqing Medical University between June 2020 and March 2023, with follow-up until March 2024. The primary outcome was time to treatment failure (TF), defined as LCM discontinuation or addition of other antiseizure treatments due to insufficient effectiveness and/or treatment-emergent adverse events (TEAEs). Secondary outcomes included retention time, responder rate and seizure-free rate. Safety was assessed by TEAEs incidence. Kaplan-Meier survival analysis and Cox regression were used.
RESULTS: A total of 98 patients (25 with DEE) were included in final analysis. Median follow-up was 20.7 months; mean age at treatment initiation was 10.9 months. At 12, 24, and 36 months, probabilities of not experiencing LCM TF were 63.2 %, 54.1 %, and 54.1 %; probabilities of retention were 86.2 %, 81.3 %, and 81.3 %. At 12 months, overall responder and seizure-free rates were 76.6 % and 50.6 %. In the DEE subgroup, the 12-month probability of not experiencing TF was 37.9 %, and retention was 75.8 %. Higher baseline seizure frequency, abnormal neuroimaging, and history of status epilepticus were independent risk factors for TF. TEAEs occurred in 18.4 %, with somnolence most common.
CONCLUSION: LCM is effective and well tolerated in infants with epilepsy, including those with DEE, supporting it a viable treatment option in this population.
METHODS: This single-center prospective cohort study enrolled children who received LCM as monotherapy or adjunctive therapy at Children's Hospital of Chongqing Medical University between June 2020 and March 2023, with follow-up until March 2024. The primary outcome was time to treatment failure (TF), defined as LCM discontinuation or addition of other antiseizure treatments due to insufficient effectiveness and/or treatment-emergent adverse events (TEAEs). Secondary outcomes included retention time, responder rate and seizure-free rate. Safety was assessed by TEAEs incidence. Kaplan-Meier survival analysis and Cox regression were used.
RESULTS: A total of 98 patients (25 with DEE) were included in final analysis. Median follow-up was 20.7 months; mean age at treatment initiation was 10.9 months. At 12, 24, and 36 months, probabilities of not experiencing LCM TF were 63.2 %, 54.1 %, and 54.1 %; probabilities of retention were 86.2 %, 81.3 %, and 81.3 %. At 12 months, overall responder and seizure-free rates were 76.6 % and 50.6 %. In the DEE subgroup, the 12-month probability of not experiencing TF was 37.9 %, and retention was 75.8 %. Higher baseline seizure frequency, abnormal neuroimaging, and history of status epilepticus were independent risk factors for TF. TEAEs occurred in 18.4 %, with somnolence most common.
CONCLUSION: LCM is effective and well tolerated in infants with epilepsy, including those with DEE, supporting it a viable treatment option in this population.