Vigabatrin in refractory childhood epilepsy. The Brazilian Multicenter Study
J L Gherpelli1, M M Guerreiro, J C da Costa
1Serviço de Neurologia Infantil, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, Brazil.
Insights
Vigabatrin effectively reduced seizure frequency in children with severe drug-resistant epilepsy. While some experienced adverse effects, the drug demonstrated significant efficacy for both partial and generalized seizures.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Epilepsy is a common neurological disorder in children.
- Drug-resistant epilepsy poses significant treatment challenges.
- Vigabatrin is an antiepileptic drug with a known mechanism of action.
Purpose of the Study:
- To evaluate the efficacy and safety of vigabatrin as an add-on therapy in children with severe drug-resistant epilepsy.
- To assess the impact of vigabatrin on seizure frequency in different seizure types.
Main Methods:
- A prospective, open-label, add-on trial involving 47 children with severe drug-resistant epilepsy.
- Exclusion of patients with West syndrome and idiopathic generalized epilepsies.
- Dosage of vigabatrin ranged from 19.3 to 110.5 mg/kg per day, with a mean of 63.6 mg/kg.
Main Results:
- Significant decrease in seizure frequency for both partial (P = 0.022) and generalized seizures (P < 0.0001).
- Over 50% seizure reduction achieved in 39.5% of partial and 60.8% of generalized seizures.
- Adverse effects reported in 38.3% of patients, including irritability, hyperactivity, and somnolence.
Conclusions:
- Vigabatrin is an effective treatment option for reducing seizure frequency in children with severe drug-resistant epilepsy.
- The drug's safety profile requires careful monitoring due to potential adverse effects.
- Further research may explore optimal dosing and long-term outcomes.
Abstract:
Children, 47, with various types of severe drug-resistant epilepsy were entered into a prospective, add-on, open trial with vigabatrin. Patients with West syndrome and idiopathic generalized epilepsies were excluded. Seven children had the drug withdrawn, five because of increase in seizure frequency and two because of adverse effects. Drug efficacy, measured according to seizure type, showed a 100% decrease in seizure frequency in 18.6% of partial seizures and 17.3% of the generalized seizures. There was a higher than 50% decrease in 39.5% of partial and 60.8% of generalized seizures, and less than 50% decrease or increase in seizure frequency in 41.8% and 21.8% of partial and generalized seizures, respectively. Vigabatrin mean dosage during phase 3 was 63.6 mg/kg per day (S.D. = 30.5), ranging from 19.3 to 110.5 mg/kg per day. Parametric statistical analysis (Student's t-test) of seizure frequency between phases 1 and 3 showed a significant decrease in seizure frequency for partial (P = 0.022), and generalized seizures (P < 0.0001). Drug-related adverse effects were observed in 18/47 cases (38.3%), consisting mainly of irritability, hyperactivity, dizziness, somnolence and gastrointestinal symptoms.
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