We report the results of 2 placebo-controlled studies in which Vigabatrin was added to the pre-existing therapy in a group of patients with drug-resistant partial epilepsy. In the first study, Vigabatrin (2 to 3 g/d, stratified according to weight) and placebo were administered orally under double-blind conditions, each for 3 months using a cross-over design. Out of 31 patients who entered the study, 30 completed the trial. Of these, 10 patients (33%) showed a decrease of seizure frequency of 50% or more. In the 15 patients presenting with complex partial seizures, 'temporal' EEG 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 EEG abnormalities and high seizure frequency. The second study consisted of 3 treatment periods: a 3-month baseline period, in which placebo was administered under single-blind conditions, a 2-month fixed dose period, in which Vigabatrin was administered at the dose of 2 g/d, and 2/4/6-month dose modification period, in which Vigabatrin was increased or decreased to titrate the optimal dose for each patient. Out of 18 patients who entered this study, 14 completed the trial. Of these, 9 patients (64%) experienced a reduction of seizure frequency of 50% or more and 3 patients (22%) had their frequency reduced by 40 to 49%. Mean Vigabatrin optimal dose was 55.5 mg/Kg/d. In both studies, tolerability to Vigabatrin was good; the most frequently reported unwanted effect was drowsiness. Plasma concentrations of PHT showed a significant reduction during Vigabatrin treatment. The results demonstrate the efficacy and good tolerability of Vigabatrin therapy in patients with severe complex partial epilepsy.
|Title of host publication||Bollettino - Lega Italiana contro l'Epilessia|
|Number of pages||3|
|Publication status||Published - 1988|
ASJC Scopus subject areas
- Clinical Neurology