Abstracts

Ideally, the choice of treatment regimen for epilepsy patients should take into account more than simply seizure control. Increasingly, the assessment of adverse events (AEs) and of quality-of-life (QOL) have become aspects of epilepsy patient care. Traditional clinical trials have not included adequate assessment of these factors. In this study we sought to measure efficacy, safety, and medication preference data from subjects switched from immediate-release carbamazepine (IR-CBZ) to an equal total daily dose of carbamazepine extended-release capsules (CBZ-ERC). We conducted a multi-center, open label, phase IV trial to assess the tolerability, safety, and effectiveness of switching from immediate-release carbamazepine(IR-CBZ) formulations to carbamazepine extended release capsules (CBZ-ERC) in adult and adolescent epilepsy patients. All subjects were switched from their current IR-CBZ product to an equal total daily dose of CBZ-ERC. Inclusion criteria included patients with partial epilepsy on stable IR-CBZ doses of at least 400 mg/day. Patients could be on one additional antiepileptic drug (AED). Exclusion criteria included a history of status epilepticus, epilepsy syndromes in which carbamazepine is contraindicated, progressive neurological disorders, neuroleptic drugs, and CBZ-ERC treatment within 90 days of study screening. Data from 453 patients with epilepsy were collected. Assessments included a seizure diary, adverse event profile (AEP) for adults, Hague Seizure Severity and Side Effects scales (HASS and HASES respectively) for adolescents, and QOL (quality of life) instruments. In addition, subjects, parents (of adolescent subject) and physicians completed satisfaction and medication preference instruments to evaluate potential benefits of the medication switch. Mean monthly seizure count was significantly decreased both at month 3 and at termination when compared to baseline ([italic]P[/italic]=.05). Correspondingly, AEP scores showed significant improvement in CBZ-associated AEs in adults during treatment with CBZ-ERC ([italic]P[/italic]=.0001). HASS and HASES ([italic]P[/italic]=.01) showed reductions in seizure severity and medication-related side effects in adolescents. Results of quality of life instruments from patients switched to CBZ-ERC showed significant improvement across all subcategories of QOL assessed. Overall, medication satisfaction and preference instruments indicated that more subjects were satisfied with their medication at month 3 when compared to baseline. Switching from IR-CBZ to CBZ-ERC in this population of patients resulted in significant improvements in seizure counts, AEP scores in adults and better HASS and HASES scores in adolescents.
This study demonstrated improvement in multiple measures of patient QOL with a change from IR-CBZ to CBZ-IR. (Supported by Shire Pharmaceutical)