J. Sivenius et al., LONG-TERM STUDY WITH GABAPENTIN IN PATIENTS WITH DRUG-RESISTANT EPILEPTIC SEIZURES, Archives of neurology, 51(10), 1994, pp. 1047-1050
Objective: To study the efficacy and safety of gabapentin in long-term
treatment. Design: A 4-year follow-up study of 25 patients with visit
s at 3-month intervals. Setting: The patients were followed up in the
outpatient unit of the University Hospital of Kuopio (Finland). Patien
ts: We treated 25 patients with drug-resistant complex partial seizure
s and secondarily generalized seizures in an open-label long-term stud
y, using gabapentin as an additional means of therapy after a 3-month
double-blind, placebo-controlled phase. Thirteen patients showed no be
nefit from gabapentin; the study medication was discontinued after 4 t
o 6 months of treatment. Of the 12 patients who responded enough to co
ntinue treatment, five were withdrawn due to different reasons, one be
cause of loss of response. Main Outcome Measures: The number of patien
ts receiving the study drug in the follow-up and reduction of seizure
frequency from baseline level as analyzed by the Wilcoxon test. Result
s: Seven patients received gabapentin therapy for more than 4 years. T
he median follow-up time was 54 months. There was a significant reduct
ion in seizure frequency throughout the follow-up period. Five of seve
n patients had a greater than 50% seizure frequency reduction at dr ye
ars, representing 20% of the 25 patients who entered the study. Conclu
sions: Gabapentin possesses good efficacy in long-term treatment of pa
tients with partial and secondarily generalized epileptic seizures. It
is safe to use, and it is fairly well tolerated even in long-term tre
atment.