Abstracts

To evaluate seizure-free response rates in patients with newly diagnosed and refractory partial seizures who received oxcarbazepine (OXC) monotherapy after 3, 6, and 12 months of treatment. Data from 9 double-blind, randomized, parallel-group clinical studies designed to evaluate the safety and efficacy of oxcarbazepine in newly diagnosed and refractory patients who received OXC were pooled and analyzed. One study was placebo-controlled (1200 mg/day), 5 were active-control studies (4 studies: 2400 mg/day; 1 study: 2100 mg/day), 2 were dose-controlled studies (300 and 2400 mg/day), and 1 was a regimen-controlled study (2700 mg/day BID vs TID). The duration of the double-blind period for the studies ranged from 12 to 60 weeks. Responder rates (seizure free, [ge]75% and [ge]50% reduction in seizure frequency) through 3 months, 6 months and 1 year were analyzed for the intent to treat (ITT) population and patients who completed 1 year of therapy (completers). The placebo-controlled study and 2 dose-controlled studies were not included in the completer analysis since the duration of these studies was less than 1 year. Within each population, newly diagnosed and refractory subgroups were analyzed separately. A total of 674 patients were included in the ITT analysis: 343 newly diagnosed and 331 refractory patients. Of the 286 completers, 208 were newly diagnosed and 78 were refractory patients. For the ITT population, the mean baseline seizure rate was 4.2 seizures/28 days for the newly diagnosed patients and 8.7 seizures/28 days for the refractory. For the completers, the mean baseline rate was 3.4 and 2.4 seizures/28 days for the newly diagnosed and refractory, respectively. Response rates for the newly diagnosed and refractory patients are presented below:[table1] Collectively, the results of this meta-analysis suggest that a sizeable proportion of patients with partial seizures become seizure-free after 3 months of oxcarbazepine monotherapy. Furthermore, newly diagnosed patients who become seizure-free tend to remain seizure-free over the long-term with continued oxcarbazepine monotherapy. (Supported by Novartis Pharmaceuticals.)