DIFFERENTIAL EFFICACY OF OXCARBAZEPINE AND CARBAMAZEPINE DURING ADJUNCTIVE THERAPY IN CHILDREN WITH REFRACTORY PARTIAL EPILEPSY
Abstract number :
1.174
Submission category :
Year :
2002
Submission ID :
3242
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Rajesh Sachdeo, Tracy Glauser, James Wheless, Martina Bebin, Ahmad Beydoun, Joseph D[ssquote]Souza. Neurology, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ; Neurology, Children[ssquote]s Hospital Medical Center, Cincinnati, OH; Ne
RATIONALE: To evaluate the efficacy of oxcarbazepine (OXC) during adjunctive therapy with or without carbamazepine (CBZ) in children with inadequately controlled partial-onset seizures.
METHODS: During the Baseline Phase of this randomized, double-blind, placebo-controlled, parallel-group study, patients (3-17 years) were maintained on their stable dose of concomitant antiepileptic drugs (AEDs). During the Double-blind Treatment Phase patients were randomized to adjunctive therapy with OXC (initial dose 10 mg/kg/day titrated over 14 days to a target dose 30-46 mg/kg/day) or placebo. Patients unable to achieve the target dose range were titrated to maximum tolerated dose. All dose adjustments were performed in a blinded manner. Median percentage change from baseline in partial seizure frequency/28 days during the double-blind phase was compared in patients who received CBZ as a concomitant AED versus those who did not receive CBZ as a concomitant AED.
RESULTS: A total of 267 patients were randomized (138 received OXC: 61 OXC/no CBZ, 77 OXC/CBZ; 129 received placebo: 74 Placebo/no CBZ, 55 with Placebo/CBZ). Median baseline seizure frequency per 28 days for the OXC/no CBZ group was 15.0 compared with 14.8 for the Placebo/no CBZ group, and was 11.9 for the OXC/CBZ group compared with 10.9 for the Placebo/CBZ group. When compared with placebo, both OXC/CBZ (33.7%, p=0.0001) and OXC/no CBZ (39.5%, p=0.0044) demonstrated significant reductions in median partial seizure frequency/28 days during the double-blind phase relative to baseline.
CONCLUSIONS: Adjunctive therapy with oxcarbazepine was equally efficacious in children with partial seizures whether added to CBZ or to other AEDs.
[Supported by: Novartis Pharmaceuticals]; (Disclosure: Salary - D[ssquote]Souza - Novartis Pharmaceuticals, Grant - Sachdeo, Glauser, Wheless, Bebin, Beydoun - Novartis Pharmaceuticals, Consulting - Sachdeo, Glauser, Beydoun - Novartis Pharmaceuticals, Honoraria - Sachdeo, Glauser, Beydoun - Novartis Pharmaceuticals)