Abstracts

A statistical analysis of data from a double-blind, randomized, placebo-controlled study of oxcarbazepine as adjunctive therapy in children with inadequately controlled partial seizures while on one or two antiepileptic drugs, was performed to allow cross-study comparison of seizure-free rates between different antiepileptic drugs.
Data from 264 children (oxcarbazepine group n=136; placebo group n=128) with a median 28-day baseline seizure frequency of 13 (range: 2-1470) were analyzed. Based on the ITT analysis for the 16-week, Double-blind Phase, 41% and 22% of patients from the oxcarbazepine and placebo groups, respectively, presented with a [ge]50% reduction in seizure frequency, and five patients on oxcarbazepine versus one on placebo were seizure-free (Glauser, et al. Neurology 2000;54:2237-2244). The seizure data were further analyzed according to seizure-free outcome evaluation periods published for add-on treatment with levetiracetam (8-week, 2/23 patients), gabapentin (12-week, 3/113 patients) and topiramate (16-week, 2/41 patients) (Appleton, et al. Epilepsia 1999; Elterman, et al. Neurology 1999;52:1338-1344; Glauser, et al. Epilepsia 2002;43:518-524).
The proportion of seizure-free patients during the last 8, 12 and 16 weeks of the 16-week Double-blind Phase were: 15% (18/121), 9% (11/117) and 4% (3/85) for oxcarbazepine, respectively, compared with 2% (3/122), 3% (3/120) and 0% (0/86) for placebo, respectively. Overall, 27% (37/135) of patients in the oxcarbazepine group and 7% (9/128) of patients in the placebo group experienced a [ge]75% reduction in seizure frequency during the 16-week Double-blind Phase.
The analysis of seizure data from an oxcarbazepine clinical study using similar methods published for other antiepileptic drugs allows cross comparison of seizure-free rates, and may assist in the selection of add-on treatment for children with inadequately controlled partial seizures.
[Supported by: Novartis Pharma AG]