OXCARBAZEPINE IS AT LEAST AS EFFECTIVE AS AND BETTER TOLERATED THAN VALPROATE FOR LONG-TERM TREATMENT IN NEWLY DIAGNOSED PATIENTS WITH EPILEPSY
Abstract number :
2.259
Submission category :
Year :
2003
Submission ID :
649
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
Walter Christe, Nikolaos Sfikas, Michael Miller Dept of Neurology, Klinikum Ernst von Bergmann, Postdam, Germany; Novartis Pharma, Basel, Switzerland; Novartis Pharma, East Hanover, NJ
To evaluate the long-term safety and efficacy of oxcarbazepine monotherapy in patients with newly diagnosed epilepsy who had completed a 1-year, double-blind, randomized trial versus valproate.
During the randomized, double-blind portion of the study, patients with newly diagnosed generalized tonic-clonic seizures or partial seizures were randomized to 300 mg/day oxcarbazepine or valproate. Dosages were titrated biweekly over an 8-week flexible Titration Period based on clinical response and tolerability. At the end of the Titration Period, patients were maintained on their daily dose (median dose of 900 mg/day for both drugs) during the 48-week Maintenance Period. We report the 1-year safety and efficacy results from the Open-label Follow-up (OF) where patients were maintained on their randomized study drug for a further 12-months. Efficacy results were obtained by comparing the seizure frequency during the OF with the double-blind Maintenance Period.
Of the 156 patients completing the Double-blind Phase, data from a total of 147 patients (oxcarbazepine n=73; valproate n=74) were available from the OF. Mean age was 33.4 ([plusmn]13.6) years. The 1-year seizure free rates from the start of the OF were similar: 62.5% ([plusmn]6.7%) for oxcarbazepine versus 58.6% ([plusmn]6.3%) for valproate. During the OF, mean weekly seizure rates were lower for both oxcarbazepine (p=0.010) and valproate (p=0.027) compared with their corresponding double-blind seizure rates. Tolerability was rated as [lsquo]good[rsquo] or [lsquo]excellent[rsquo] by 90% of patients receiving oxcarbazepine versus 76% receiving valproate. The most common adverse events ([gt]8%) were headache (oxcarbazepine 14.5%; valproate 15.3%), viral infection (oxcarbazepine 8.4%; valproate 7.1%) and tremor (oxcarbazepine 1.2%; valproate 8.2%). Reasons for discontinuations were unsatisfactory seizure control (oxcarbazepine 1, valproate 3) and adverse events (oxcarbazepine 1, valproate 1).
These results indicate that oxcarbazepine monotherapy is as effective as valproate in maintaining seizure control during long-term treatment in adult patients with newly diagnosed epilepsy with an improved safety profile
[Supported by: Novartis Pharma]