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Clinical trial of vigabatrin as adjunctive therapy in children with refractory epilepsy
Mohammad-Mahdi Taghdiri1, Mahmoud-Reza Ashrafi2, Mohammad-Kazem Bakhshandeh-Bali3
1Department of Pediatrics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Vigabatrin effectively reduced seizure frequency in children with intractable epilepsy, with over 50% decline after three and six months. The study confirmed its short-term efficacy and safety in this pediatric population.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Epilepsy affects many children, with approximately one-third experiencing inadequate seizure control.
- Intractable epilepsy poses significant challenges in pediatric care, necessitating effective treatment options.
Purpose of the Study:
- To evaluate the efficacy and safety of Vigabatrin as an add-on therapy for children with refractory epilepsy.
- To assess the impact of Vigabatrin on seizure frequency and severity in pediatric patients.
Main Methods:
- A prospective study involving 73 children with refractory epilepsy treated with Vigabatrin alongside existing anticonvulsant medications.
- Patients were monitored for seizure frequency, severity, and side effects over three to six months.
Main Results:
- Vigabatrin significantly reduced daily seizure frequency by 56% at three months and 54.5% at six months (P<0.001).
- Common side effects included somnolence and abnormal electroretinographic patterns, with overall good tolerability.
- The study included 67 children (61.2% male) with a mean age of 3.1 years.
Conclusions:
- Vigabatrin demonstrates short-term efficacy in reducing seizure frequency in children with refractory epilepsy.
- The findings support the use of Vigabatrin as a safe and effective treatment option for this patient group.
Objective:
Approximately one-third of all children with epilepsy do not achieve complete seizure improvement. This study evaluated the efficacy of Vigabatrin in children with intractable epilepsy.
Methods:
From November 2011 to October 2012, 73 children with refractory epilepsy (failure of seizure control with the use of two or more anticonvulsant drugs) who were referred to the Children's Medical Center and Mofid Children's Hospital were included in the study. The patients were treated with Vigabatrin in addition to their previous medication, and followed-up after three to four weeks to determine the daily frequency, severity, and duration of seizures in addition to any reported side effects.
Findings:
Of the 67 children, 41 (61.2%) were males and 26 (38.8%) females, their age ranging from three months to 13 years with an average of 3.1 [standard deviation (SD), 2.6] years. The mean daily frequency of seizures at baseline was 6.61 (SD, 5.9) seizures per day. Vigabatrin reduced the seizure frequency ≤2.9 (SD, 5.2) (56% decline) and 3.0 (SD, 5.3) (54.5% decline) per day after three and six months of treatment, respectively. A significant difference was observed between seizure frequencies at three (P<0.001) and six months (P<0.001) after Vigabatrin initiation compared with the baseline. Somnolence [3 (4.5%)], horse laugh [1 (1.5%)], urinary stones [1 (1.5%)], increased appetite [1 (1.5%)], and abnormal electroretinographic pattern [3 (4.5%)] were the most common side effects in our patients.
Conclusion:
This study confirms the short-term efficacy and safety of Vigabatrin in children with refractory epilepsies.
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