Thirty adult patients with drug-resistant partial epilepsy who had res
ponded favorably to add-on vigabatrin under placebo-controlled conditi
ons were maintained on long-term treatment with the drug. Twenty patie
nts are still in the trial with a follow-up ranging from 26 to 70 mont
hs (median, 60). Ten patients were withdrawn from the study after havi
ng received the drug for 4-14 months (median, 9) because of seizure br
eakthrough (n = 7) and other reasons (n = 3). Overall, the initially f
avorable therapeutic response was generally maintained during the long
-term treatment. Side effects were minor, the most frequent being a mo
derate gain in body weight. Plasma concentrations of phenytoin were si
gnificantly reduced during vigabatrin treatment. Our findings suggest
that vigabatrin retains its anticonvulsant efficacy in about two-third
s of the patients after a 5-year follow-up period. Tolerability is als
o good during long-term treatment.