Double-blind study of vigabatrin in the treatment of drug-resistant epilepsy
C. A. Tassinari, R. Michelucci, G. Ambrosetto and F. Salvi
Thirty-one patients with severe drug-resistant epilepsy entered the study.
Vigabatrin (2 to 3 g/d, stratified according to weight) and placebo were
administered orally, as add-on therapy in random order under double-blind
conditions, each for three months using a crossover design. Thirty patients
completed both periods. Of these, ten patients (33%) showed a decrease in
seizure frequency of 50% or more. In the 15 patients presenting with
complex partial seizures, "temporal" electroencephalographic abnormalities,
and relatively low seizure frequency, there was a significant reduction in
seizure frequency during vigabatrin treatment. No significant treatment
effect was found for the remaining 15 patients, who presented with mixed
seizure types, multifocal electroencephalographic abnormalities, and high
seizure frequencies. Tolerability to vigabatrin was good; the most
frequently reported unwanted effect was drowsiness. Plasma concentrations
of phenytoin showed a significant reduction during the vigabatrin period.
The results demonstrate the efficacy and good tolerability of vigabatrin
therapy in patients with severe complex partial epilepsy.
