Abstracts

RATIONALE: To evaluate the 2-year long-term safety and efficacy of oxcarbazepine (OXC) in presurgical patients with uncontrolled partial-onset seizures who had completed a double-blind, placebo-controlled phase.
METHODS: In this randomized, double-blind, placebo-controlled, parallel-group trial, all antiepileptic drugs (AEDs) were discontinued at least 48 hours before randomization, except lorazepam up to 8 mg/day to maintain seizure frequency in a safe range. Patients (aged 11-62 years) were randomized to receive either OXC 2400 mg/day or placebo for the 10-day Double-blind Phase. Patients exited the study by completing the 10-day Double-blind Phase or by experiencing 4 partial seizures, 2 new-onset secondary generalized seizures, serial seizures or status epilepticus. After exiting from the Double-blind Phase, patients were eligible to enter an Open-label Extension Phase. During the Open-label Extension Phase, patients received 1500 mg/day for 1 day. Thereafter, the dose was adjusted for each patient to provide the lowest dose that provided seizure control with acceptable tolerability. The maximum allowable dose was 3000 mg/day except with monitor approval. Concomitant AEDs were allowed during the Open-label Extension Phase. We report the 2-year safety and efficacy results.
RESULTS: A total of 97 patients (54% males, 46% females) with a mean age of 33 years entered the Open-label Extension Phase; 43 completed 2 years of open-label therapy. The reasons for exiting were unsatisfactory seizure control (30%), adverse events (17%), and other (9%). Compared to baseline, 94% (n=91) of the patients receiving OXC experienced a [gt]50% reduction in seizure frequency and 5% (n=5) remained seizure-free during the 2 year Open-label Extension Phase. These were the same 5 patients that were seizure-free at 1 year. Throughout the 2-year period, the most common adverse events (incidence [gt]20%) reported were headache (61%), dizziness (58%), diplopia (45%), fatigue (41%), nausea (36%), vomiting (27%), somnolence (24%), viral infection (22%), and abnormal vision (21%). Overall, the adverse events were mild and transient.
CONCLUSIONS: The results indicate that OXC maintains its efficacy during long-term management of patients with partial seizures.
[Supported by: Novartis Pharmaceuticals]; (Disclosure: Salary - D[ssqoute]Souza - Novartis Pharmaceuticals, Grant - Schachter, Vazquez - Novartis Pharmaceuticals, Consulting - Schachter, Vazquez - Novartis Pharmaceuticals, Honoraria - Schachter, Vazquez - Novartis Pharmaceuticals)