Abstracts

RATIONALE: The clinical development of oxcarbazepine differs from that of other new generation antiepileptic drugs in the extent and concordance of results of clinical trials conducted in patients with partial epilepsy ranging from the newly diagnosed to highly refractory populations. Although seizure freedom is the ultimate goal of treatment, this outcome is rarely reported in pivotal clinical trials. We reviewed the seizure-free and responder rates obtained in the double-blind, randomized, clinical trials of oxcarbazepine.
METHODS: We evaluated the efficacy results of nine clinical trials with oxcarbazepine and calculated the seizure-free rates during the double-blind phase of those trials using an intent-to-treat analysis. In addition, the responder rates were calculated when applicable. There were 4 active-control monotherapy trials conducted in patients with newly diagnosed epilepsy, 3 therapeutic failure design monotherapy trials conducted in patients with recent onset and refractory partial epilepsy, and 2 add-on clinical trials in adults and children with medically refractory partial epilepsy.
RESULTS: In newly diagnosed epilepsy, 52% to 61% of patients remained seizure-free throughout the 48-week maintenance phase on a mean daily oxcarbazepine dose of 1040 mg in adults and 672 mg in children. In the therapeutic failure design monotherapy trials, the seizure-free rates were 34%, 31% and 12% in outpatients with recently diagnosed partial epilepsy (OXC 1200 mg/day), inpatients undergoing presurgical epilepsy evaluations (OXC 2400 mg/day) and outpatients with medically refractory partial epilepsy (OXC 2400 mg/day), respectively. In those same trials, the 50% responder rates were 63%, 73%, and 43% respectively. In adults with refractory partial epilepsy, adjunctive treatment with oxcarbazepine resulted in seizure-free rates of 3%, 10%, and 22% in the OXC 600 mg, 1200 mg, and 2400 mg/day groups, respectively. Four percent of children with medically refractory partial epilepsy were seizure-free following adjunctive treatment with OXC at a mean daily dose of 31 mg/kg/day.
CONCLUSIONS: Treatment with oxcarbazepine resulted in seizure freedom in various populations with partial epilepsy. Seizure freedom can result in significant improvement in quality of life.
Disclosure: Salary - Novartis (Joseph D[ssquote]Souza). Grant - Novartis. Stock - Novartis (Joseph D[ssquote]Souza). Honoraria - Novartis.