Vigabatrin in uncontrolled seizures: Belgian clinical experience. The Belgian Vigabatrin Evaluation Group.
The antiepileptic activity of vigabatrin has been established in several double-blind, placebo-controlled, clinical trials. The purpose of this study was to evaluate the efficacy and tolerability of this new antiepileptic drug in normal clinical practice rather than in controlled studies. A total of 102 patients (46 females and 56 males, ranging in age from 1 to 62 years) with previously uncontrolled seizures were treated with vigabatrin (0.5-4 g/day) as add-on medication, on an individual patient basis by 39 neurologists, for a mean duration of 235 days (range 30-520 days). Efficacy of vigabatrin was assessed after 3 months of therapy. Sixty-five patients (63.7%) showed a > 50% decrease in seizure frequency, and 12 patients (11.7%) became seizure-free. Thirty-one patients (29.4%) experienced a < 50% decrease or no change in seizure frequency, and 6 patients (5.9%) had an increase in seizure frequency. Adverse events, nearly all of mild severity, were reported in 27 patients (26.5%). These data are remarkably similar to previous placebo-controlled studies and support that vigabatrin is beneficial to a significant number of patients with previously uncontrolled seizures.