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We followed 66 patients with refractory complex partial seizures and a favorable initial response to vigabatrin for 5 to 72(median,43)months. Thirty-seven patients discontinued vigabatrin for the following reasons: benefit-to-risk evaluation,8;seizure breakthrough,6;adverse events,6; seizure breakthrough and adverse events,5;moved or lost,4;no longer eligible for study,2;non-drug-related death,2;narcotic abuse,1;and patient request,three.There were no clinically significant abnormalities in laboratory studies including SMA12,complete blood count,ECG,EEG,and visual evoked response testing,and no toxicity other than reversible,dose- dependent side effects.Based on this and other long-term data,clinical trials of vigabatrin have resumed in the United States and Canada. |
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