Abstracts

Patients with epilepsy often report that the presence or absence of AED side-effects are as important as seizure control in successful therapy. The Adverse Event Profile (AEP) has been shown to be an effective tool for detecting clinically significant anticonvulsant side-effects and for helping physicians to optimize anticonvulsant therapy. We compared patients tolerability to carbamazepine during treatment with immediate-release carbamazepine (IR-CBZ) and an equal total daily dose of Carbatrol[reg] extended-release capsules (CBZ-ERC) in a large multi-center study using the AEP for adults ([ge]18 years of age); and the Hague side-effects (HASES) scales for adolescents ([lt]18 years of age). Patients were enrolled in the multi-center study (n= 457) if they had partial-onset seizures and were currently treated with IR-CBZ. During IR-CBZ treatment, patients had baseline (month 0) evaluation with the adverse event profile (AEP; adults), the 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). 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 HASES is a 20-item questionnaire scored on a scale of 1 (not a problem) to 4 (very serious problem), and takes into account the same variables as the AEP with the exception of concentration difficulty. Adults (n=419) converted to CBZ-ERC had significant decreases in adverse events on the AEP scale compared to AEP scores during treatment with IR-CBZ ([italic]P[/italic]=.0001), with adults 18-59 showing the most improvement (-6.0 points on AEP total score; [italic]P[/italic]=.0001).Adolescents (n=38) also had significant decreases in side-effects in the HASES inventory ([italic]P[/italic]=.01), with decreases in depression and sedation being most prevalent. Subscale scores of both inventories showed decreases in adverse events with conversion from IR-CBZ to CBZ-ERC. Most commonly occurring AEs were headache, dizziness, and fatigue. The AEP and HASES were useful tools for documenting changes in adverse events during treatment with immediate-release and extended release formulations of carbamazepine. Patients treated with CBZ-ERC had significantly fewer CNS side-effects compared to treatment with IR-CBZ on these adverse event inventories.[figure1] (Supported by Shire
Carbatrol is registered in the United States Patent and Trademark Office.)