Abstracts

RATIONALE: Two key parameters assessed in epilepsy trials are efficacy and safety, however, health related quality of life (HRQOL) assessment is needed to complement these clinical outcomes. There is a minimal amount of data on QOL in patients treated with oxcarbazepine(OXC).
METHODS: This was an open-label, single arm, 16 week treatment, study of patients who received OXC monotherapy due to uncontrolled seizures (2-40/month in the two months prior to study enrollment), or intolerable adverse events, on their present antiepileptic drug (AED) monotherapy. Eligible patients were males and females, 12 years of age or older with a diagnosis of partial epilepsy (simple, complex, secondarily generalized). Treatment with OXC started at 300mg bid and could be increased in weekly increments no greater than 600mg/day as needed; with a maximum dose of 2400mg/day. Concomitant (pre-study) AED therapy was switched to OXC over a four-week period. Efficacy assessments consisted of the change in seizure frequency, the Quality of Life in Epilepsy Inventory (QOLIE-31), and the Investigator[ssquote]s Global Assessment of seizure control and AED tolerability.
RESULTS: 245 patients entered this study, 73% completed and 17.1% discontinued due to adverse events. The study population was 54.3% females, had a mean age of 35.5 years and a mean weight of 77.2 kg. The mean daily dose of OXC at endpoint was 1351.5mg/day. A 50% reduction in seizure frequency was observed in 52% of patients and a 100% reduction was seen in 14.5% of patients. The mean and median baseline QOLIE-31 composite scores were 60.5 and 62.6, respectively. The endpoint mean, median and percentage changes in composite score and all sub-scales are in table 1 below ([DELTA]=endpoint-baseline). The most common adverse events observed were CNS or gastrointestinal in nature and were generally mild to moderate in intensity.
CONCLUSIONS: Epilepsy patients with partial seizures who transitioned to OXC monotherapy showed statistically significant positive changes in quality of life as demonstrated by the QOLIE-31 instrument and its sub-scales. In addition, a significant reduction in seizure frequency was observed, with 14.5% of patients seizure free.[table]
Support: Novartis Pharmaceuticals Corporation
Disclosure: Salary - Stephen Graham, Scott Constantine - Novartis Pharmaceuticals Corporation Employees; Grant - Satind Sachdeo, John Gates - Novartis Pharmaceuticals Corporation; Consulting - Satind Sachdeo, John Gates - Novartis Pharmaceuticals Corporation; Honoraria - Satind Sachdeo, John Gates - Novartis Pharmaceuticals Corporation