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The effectiveness and safety of lacosamide in infants with epilepsy aged under 2 years: A prospective study
Liu Tailin1, Xiong Li1, Liu Jing1
1Department of rehabilitation Center, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 400014, China.
Insights
Lacosamide (LCM) is effective and well-tolerated in infants with epilepsy, including those with developmental epileptic encephalopathy (DEE). This study supports LCM as a viable treatment option for this young patient population.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Epilepsy in infants aged 1 month to 2 years presents unique challenges.
- Developmental Epileptic Encephalopathy (DEE) is a severe form of childhood epilepsy.
- Limited data exists on the efficacy and safety of lacosamide (LCM) in this specific age group.
Purpose of the Study:
- To evaluate the effectiveness and safety of lacosamide (LCM) in infants (1 month to 2 years) with epilepsy.
- To assess LCM's efficacy in children with Developmental Epileptic Encephalopathy (DEE).
- To identify risk factors associated with lacosamide treatment failure.
Main Methods:
- Prospective cohort study at a single center.
- Inclusion of 98 infants with epilepsy, 25 with DEE, treated with LCM (monotherapy or adjunctive).
- Primary outcome: time to treatment failure; secondary outcomes: retention, responder, and seizure-free rates; safety assessed via treatment-emergent adverse events (TEAEs).
Main Results:
- At 12 months, overall responder rate was 76.6% and seizure-free rate was 50.6%.
- Probabilities of not experiencing treatment failure at 12, 24, and 36 months were 63.2%, 54.1%, and 54.1%, respectively.
- Higher baseline seizure frequency, abnormal neuroimaging, and history of status epilepticus were risk factors for treatment failure; 18.4% experienced TEAEs, most commonly somnolence.
Conclusions:
- Lacosamide (LCM) demonstrates effectiveness and good tolerability in infants with epilepsy.
- LCM is a viable treatment option for infants, including those with DEE.
- Further research may explore optimizing LCM use based on identified risk factors.
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.
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