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 treated with vigabatrin (38 patients) or carbamazepine (32 patients). INTERVENTION Vigabatrin, 50 to 60 mg/kg per day, or carbamazepine, 15 to 20 mg/kg per day, split into twice-a-day doses. OUTCOME MEASURES The efficacy and tolerability of vigabatrin were compared with those of the standard treatment (carbamazepine) for this patient group. 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 monotherapeutic treatment option in patients with newly diagnosed epilepsy. However, more studies are needed to evaluate other issues of concern, such as the cognitive and behavioral adverse effects of antiepileptic drugs, to determine the most suitable therapy.