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Add-On Vigabatrin in Children with Refractory Epilepsy

A 4-Year Follow-Up Study

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Summary

Information on the long term efficacy and tolerability of vigabatrin in children is scarce. This open, 4-year add-on study reports the effects of vigabatrin in 22 children aged 26 to 220 months with refractory epilepsy. The 22 children entered this 4-year long term study after 2 months of add-on vigabatrin at a fixed dose, and two 2-month periods of vigabatrin adjustment.

During those 4 years, 2 patients with complete response moved away, 3 with a seizure reduction of > 50% left the study at parental request, and 5 (23%) were withdrawn because of inefficacy or an increase in seizure frequency. Five patients (23%) reported adverse events such as drowsiness, fatigue, apathy, constipation and aggressiveness, although none resulted in vigabatrin withdrawal. In the 12 children completing the study, vigabatrin at a daily dose of 63.8 ± 19.0 mg/kg reduced the median number of seizures from 30 seizures/month at baseline to 0 seizures/month at the end of the 4 years (p < 0.05) — a seizure reduction of > 50% in 9 of the 12 patients (complete control in 7 patients).

It is concluded that add-on vigabatrin achieved a 4-year long term benefit in at least 40% of children with refractory partial epilepsy, and that the development of tolerance or adverse events were rarely observed in this period.

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Authors and Affiliations

  1. Department of Neuropaediatrics, University of Cantabria School of Medicine, ‘M. de Valdecilla’ University Hospital, Santander, Spain

    Rosa Arteaga & José L. Herranz

  2. Department of Clinical Pharmacology, University of Cantabria School of Medicine, ‘M. de Valdecilla’ University Hospital, E-39008, Santander, Spain

    Juan A. Armijo

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  1. Rosa Arteaga
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  2. José L. Herranz
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  3. Juan A. Armijo
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Arteaga, R., Herranz, J.L. & Armijo, J.A. Add-On Vigabatrin in Children with Refractory Epilepsy. Clin. Drug Invest. 12, 287–297 (1996). https://doi.org/10.2165/00044011-199612060-00002

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  • DOI: https://doi.org/10.2165/00044011-199612060-00002

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