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Dose-Response Study of Vigabatrin in Children With Refractory Epilepsy

Neuropaediatric, Valdecilla Hospital, University of Cantabria, Santander, Spain

R. Arteaga, MD, PhD

Neuropaediatric, Valdecilla Hospital, University of Cantabria, Santander, Spain

I.N. Farr, MD

Marion Merrell Dow Research Centre, Winnersh, UK

E. Valdizan, MD

Clinical Pharmacology Services, Valdecilla Hospital, University of Cantabria, Santander, Spain

D. Beaumont, MD

Marion Merrell Dow Research Centre, Winnersh, UK

J.A. Armijo, MD, PhD

Clinical Pharmacology Services, Valdecilla Hospital, University of Cantabria, Santander, Spain

Twenty children aged 2 months to 18 years were included in a dose-response study of vigabatrin as add-on therapy to preexisting antiepileptic drugs (up to two per patient). All children had severe refractory epilepsy: partial seizures with or without secondary generalization in 19, and myoclonic seizures in one. After a 2-month observation period and a 1-month add-on placebo period, a fixed dose of add-on vigabatrin was given for 2 months: 1, 1.5, or 2 g/day, according to body weight (mean dose, 60 mg/kg/day). Three patients (15%) became seizure free, and nine (45%) showed a 50% to 99% reduction in seizure frequency. In the 17 patients whose seizures were not totally suppressed, vigabatrin dose was increased for a further 2 months, and in 7 patients who still showed less than 50% reduction in seizure frequency, vigabatrin dose was increased again. Efficacy appeared unchanged by these higher doses. During a 9-month follow-up phase, no tolerance to the effects of vigabatrin was observed, with three children seizure free and 13 (65%) reporting a 50% to 99% reduction in seizure frequency. During the study, adverse effects were recorded in three children (15%), namely drowsiness, constipation, fatigue, and apathy. These effects were generally transient, being observed during the dose-modification phase and disappearing either spontaneously or on reduction of vigabatrin dose. Clinical and laboratory tolerability to vigabatrin appeared to be very good, with no patients having withdrawn from the study because of side effects. A slight reduction in red blood cell count and hemoglobin levels was noted but was of doubtful clinical significance. There was also a slight, nonsignificant decrease in phenytoin plasma levels. In conclusion, vigabatrin is an effective and well-tolerated therapy in children with refractory epilepsy at the dose of 60 mg/kg/day. Higher doses do not appear to bring any further significant benefit. (J Child Neurol 1991;6(Suppl):2S45-2S51).

Journal of Child Neurology, Vol. 6, No. 2 Suppl, 2S45-2S51 (1991)
DOI: 10.1177/0883073891006002091


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This article has been cited by other articles:

				A. Lortie, C. Chiron, C. Dumas, J. P. Mumford, and O. Dulac Optimizing the Indication of Vigabatrin in Children With Refractory Epilepsy J Child Neurol, June 1, 1997; 12(4): 253 - 259. [Abstract] [PDF]