Open comparative long-term study of vigabatrin vs carbamazepine in newly diagnosed partial seizures in children

Objective: To compare vigabatrin with carbamazepine as monotherapy in newly diagnosed children with partial epilepsy in order to evaluate the efficacy and tolerability of both drugs. Design: Open and randomized with a 2-year follow-up period. Setting: The Infantile Neuropsychiatric Division of the Regional Pediatric Hospital, Ancona, Italy. Patients: Seventy children with newly diagnosed partial epilepsy were treat ed with vigabatrin (38 patients) ol carbamazepine (32 patients). Intervention: Vigabatrin, 50 to 60 mg/kg per day, or carbamazepine, 15 to 2 0 mg/kg per day, split into twice-a-day doses. Outcome Measurer: The efficacy and tolerability of vigabatrin were compared with those of the standard treatment (carbamazepine) for this patient grou p. Results: The efficacy of vigabatrin and carbamazepine was similar, with the suggestion of a better side effect profile with vigabatrin. Conclusions: Vigabatrin monotherapy should be considered as a monotherapeut ic treatment option in patients with newly diagnosed epilepsy. However, mor e studies are needed to evaluate other issues of concern, such as the cogni tive and behavioral adverse effects of antiepileptic drugs, to determine th e most suitable therapy.