The objective of this study was to determine the efficacy of gabapentin as
adjunctive therapy in doses required to achieve the most effective seizure
control. There were 2016 patients with partial seizures requiring adjunctiv
e therapy who received gabapentin at doses up to 3600 mg/day in this open-l
abel, multicenter, 16-week study.
Of the 1055 patients evaluable for efficacy, 573 received gabapentin less t
han or equal to 1800 mg/day and 482 received >1800 mg/day as the highest do
se received. For the overall efficacy evaluable population, the percentage
of patients achieving at least a 50% reduction in seizure frequency was 76.
0%; 46.4% of the patients were seizure free. Patients whose highest gabapen
tin dose did not require >1800 mg/day had, at baseline, fewer seizures and
were receiving fewer concomitant antiepileptic drugs (AEDs) at baseline tha
n those patients requiring >1800 mg/day. This suggests that patients requir
ing higher doses of gabapentin were more refractory to drug treatment at th
e start of the study. Gabapentin was well tolerated at all doses in this st
udy. The results of the study demonstrate that gabapentin is effective as a
djunctive therapy in patients with partial seizures whose seizures are inad
equately controlled by traditional AEDs. (C) 2000 BEA Trading Ltd.