The long-term use of felbamate in children with severe refractory epilepsy
M R Cilio1, A I Kartashov, F Vigevano
1Division of Neurology, Bambino Gesú Children's Hospital, Rome, Italy. maria.cilio@tch.harvard.edu
Insights
Felbamate (FBM) add-on therapy showed efficacy in pediatric severe epilepsy, with about 41% of patients maintaining seizure reduction after 3 years. Common side effects included anorexia and weight loss.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Severe, uncontrolled epilepsy in children presents significant treatment challenges.
- Refractory epilepsy often requires exploring add-on antiepileptic drug therapies.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of felbamate (FBM) as adjunctive treatment for severe pediatric epilepsy.
- To assess FBM's effectiveness across different epilepsy syndromes in children.
Main Methods:
- A 3-year follow-up study involving 36 pediatric patients with severe uncontrolled epilepsy.
- Felbamate (FBM) was titrated weekly up to 45 mg/kg, with regular hematological and biochemical monitoring.
- Efficacy was measured by seizure frequency reduction (>50%) at various time points.
Main Results:
- Overall efficacy, defined as >=50% seizure reduction, decreased from 69% at 3 months to 41% at 3 years.
- Felbamate (FBM) demonstrated effectiveness in various epilepsy types, particularly simple partial, tonic, and atonic seizures.
- One-third of patients maintained substantial seizure control for at least 3 years.
- Frequent adverse events included anorexia, weight loss, urinary retention, somnolence, nervousness, and insomnia.
Conclusions:
- Felbamate (FBM) can be an effective add-on therapy for a broad spectrum of refractory pediatric epilepsies.
- While initial efficacy wanes over time, a significant proportion of patients benefit long-term.
- Careful monitoring for adverse events is crucial during felbamate (FBM) treatment in children.
Abstract:
The aim of the study was to assess the efficacy and safety of felbamate (FBM) as add-on therapy in pediatric patients with severe uncontrolled seizures during a 3-year follow-up. Thirty-six patients were enrolled between February 1994 and February 1997. Patients suffered from partial epilepsy (n=13), Lennox-Gastaut syndrome (LGS) (n=9), infantile spasms (IS) n=8 or other forms of generalized epilepsy (n=6). FBM was titrated weekly from 15 up to 45 mg/kg. By February 1995, all patients had hematological and biochemical monitoring prior to FBM therapy and every 15 days during the study. The results achieved at different treatment durations were analyzed. Overall efficacy measured as > or =50% reduction in seizure frequency varied during follow-up: 69% at 3 months, progressively decreasing to 66% at 6 months, to 47% at 1 year and 41% of the initial cohort at the end of the study. Most frequent side effects were anorexia, weight loss, urinary retention, somnolence, nervousness and insomnia. FBM controlled a broad spectrum of otherwise refractory seizures. Best results were obtained against simple partial seizures with or without secondary generalization, tonic and atonic seizures. A substantial improvement in seizure control was maintained in one-third of the patients for at least 3 years.
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