Abstracts

Optimizing treatment for patients with epilepsy must take into account more than basic seizure control. The assessment of adverse events (AEs) and tolerability are important goals in this population to balance medication dosage and efficacy. Differences in adverse event profile or severity between immediate-release and extended-release formulations of carbamazepine are not clearly defined. In this study, tolerability and safety data was obtained from subjects switched from immediate-release carbamazepine (IR-CBZ) to an equal total daily dose of Carbatrol[reg] extended-release capsules (CBZ-ERC) at a minimum of 400 mg/d. At baseline, eligible and enrolled subjects were switched from their current IR-CBZ product to an equal total daily dose of CBZ-ERC. Grounds for exclusion from this multicenter open-label study included: known history of generalized tonic-clonic status epilepticus or epilepsy syndromes that may potentially worsen with carbamazepine treatment, progressive neurological disorder, receiving more than 1 additional antiepileptic drug or any type of neuroleptic drug, or CBZ-ERC treatment within 90 days of study screening. Data from 381 patients with epilepsy were collected. Assessments performed at baseline (month 0) and month 3 included adverse event profile (AEP) for adults 18-59 years of age, Hague seizure severity (HASS) and side-effects (HASES) scales for adolescents [lt]18 years of age (filled out by parent or guardian of adolescent study participant), and monitoring of AE occurrence. The AEP is a 19-item questionnaire scored on a scale from 1 (never a problem) to 4 (always or often a problem), and takes into account sedation, dizziness, unsteadiness, concentration difficulty, depression, and double/blurred vision. The AEP (adults) as well as HASES (adolescents) showed significant decreases from baseline to month 3 in overall mean side effect score ([italic]P[/italic]=.0001 and [italic]P[/italic]=.01, respectively). Subscale scores of both questionnaires also showed significant decreases on many variables. HASS showed a decreased total score with a trend toward significance. Most commonly occurring AEs were headache, dizziness, and fatigue. Overall, 78.8% of both patients and parents (of adolescent patients), as well as 86.4% of physicians preferred CBZ-ERC to previous IR-CBZ medications. Patient responses also indicated that compared to 38.7% at baseline (IR-CBZ), 58.6% of patients [ldquo]strongly agree[rdquo] that they rarely skip or miss a dose of their medication. Patients with epilepsy switched from IR-CBZ to ERC-CBZ experienced decreased AE occurrence and severity. While 22.1% of study participants reported at least one AE, only 3.3% discontinued due to AE occurrence, and only 3.9% reported AE occurrence as [ldquo]severe[rdquo]. These data demonstrate the benefits of ERC-CBZ in terms of safety, tolerability, and preference in a clinical trial setting. (Supported by Shire.)