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.
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Marion Merrell Dow, Zaventem, Belgium.
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001530:Belgium; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D004569:Electroencephalography / Q000187:drug effects; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D012640:Seizures / Q000188:drug therapy*; D016896:Treatment Outcome; D020888:Vigabatrin; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000927:Anticonvulsants; D005680:gamma-Aminobutyric Acid; D020888:Vigabatrin