SAFETY AND EFFICACY OF OXCARBAZEPINE AFTER MORE THAN 4 YEARS TREATMENT IN PATIENTS WITH INADEQUATELY-CONTROLLED PARTIAL SEIZURES
Abstract number :
2.283
Submission category :
Year :
2003
Submission ID :
3918
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
Blanca Vazquez, Ahmad Beydoun, Rajesh C. Sachdeo Comprehensive Epilepsy Program, New York University, New York, NY; Department of Neurology, University of Michigan Medical School, Ann Arbor, MI; New Jersey Comprehensive Epilepsy Center, UMDNJ, New Brunswi
To evaluate the long-term safety and efficacy of oxcarbazepine in patients with medically refractory partial epilepsy who had completed two double-blind monotherapy studies (Sachdeo et al. Neurology 2001;57:864-871; Beydoun et al. Neurology 2000;54:2245-2251).
Eligible patients who completed either one of two double-blind, monotherapy, randomized studies were allowed to participate in the long term, Open-label Extension (OLE) Phase of the respective study. Patients who were included in the two pivotal trials were experiencing 2-40 partial-onset seizures/month despite treatment with 1-2 antiepileptic drugs. During the OLE, the daily dose of oxcarbazepine was individualized by the investigators in order to provide adequate seizure control with acceptable tolerability. The maximum allowable dose was however not to exceed 3000 mg/day. Concomitant antiepileptic drugs were allowed during the OLE Phase in both studies as clinically indicated. We report the long-term safety and efficacy results from these extensions for up to 4.5 years of treatment with oxcarbazepine.
A total of 199 patients entered the OLE phase of the two studies, and efficacy data were available from 165 patients. Overall, 42 (25%) patients received oxcarbazepine as monotherapy throughout the OLE Phase. The median dose of oxcarbazepine monotherapy was 2254 mg/day (range: 240-3370 mg/day) for a median duration of 773 days (range: 5-1667 days). A total of 22 (13%) patients were treated with oxcarbazepine monotherapy for at least 2 years. Compared with baseline, 50% of patients receiving oxcarbazepine monotherapy experienced a [ge]50% reduction in seizure frequency, 29% experienced [ge]75% reduction, and 10% were seizure-free throughout the OLE. For the remaining 123 (75%) patients receiving oxcarbazepine as adjunctive therapy, the median dose was 2337 mg/day (range: 865-3589 mg/day) for a median duration of 868 days (range: 14-1669 days). In contrast to those patients receiving monotherapy, 36% of patients were 50% responders, and 1% was seizure-free. Throughout the 4.5 years of the OLE, 17% of patients discontinued oxcarbazepine due to lack of efficacy and 21% due to adverse effects.
The results from this analysis of 4.5 years clinical experience indicate that oxcarbazepine maintains safety and efficacy as monotherapy and as adjunctive therapy in patients with partial seizures during long term treatment.
[Supported by: Novartis]