The efficacy and tolerability of vigabatrin (VGB) and carbamazepine (CBZ) monotherapy were compared in an open long-term study in newly diagnosed partial seizures in children treated at the Infantile Neuropsychiatric Division of the Regional Pediatric Hospital, Ancona, Italy. VGB, 50-60 mg/kg/day. in 38 patients or CBZ, 15-20 mg/kg/day, in 32 patients were split into twice-a-day doses given for a 2-year follow-up period. Clinical efficacy of VGB was similar to that of CBZ (76% vs 78% benefited, respectively). Relapses occurred in 24% of the VGB group and 22% of the CBZ-treated patients.
VGB adverse effects included abnormal weight gain of 10-20% in 10 (26%) patients within the first 3 months of the study, irritability/excitability and antisocial behavior in 6 (16%), and asymptomatic visual field constriction in an unspecified number. The most significant and troublesome CBZ adverse effect was a generalized urticarial rash within the first 10 days of therapy in 6 (19%) patients, associated with high fever and severe leukopenia in one. Excessive sedation occurred in 6 (19%). Effects on cognitive function were not addressed. 
COMMENT. The clinical efficacy of vigabatrin and carbamazepine monotherapy was comparable in an open long-term trial in children with newly diagnosed partial seizures. The high incidence of skin rash within 10 days of initiating CBZ therapy is a concern, and the role of VGB as an alternative treatment of childhood partial epilepsies should be studied further. The value of VGB as therapy for infantile spasms has been established and reported previously.
VGB response rate and tolerability were superior to other new antiepileptic drugs (gabapentin, lamotrigine, tiagabine) in a meta-analysis comparison of key clinical trials . Drawbacks to the use of these data included significant differences among trials in reports of placebo response; lower than average response (6%) in tiagabine trials, and higher than average response (14%) in topiramate trials. Also, drug response rates and incidence of adverse effects differed between study populations, despite use of identical protocols and patient selection.
The management of refractory seizures and their effects on the quality of life of the patient are reviewed . The optimal use of antiepileptic drugs, first-line and second-line choices, and their effects on other drug serum levels are tabulated. Vagus-nerve stimulation, recently approved as an adjunctive therapy for refractory seizures in patients older than 12 years, is discussed.