Abstracts

The assessment and monitoring of quality-of-life (QOL) has become increasingly important in clinical study populations. Traditional clinical trials often do not include adequate assessments of factors that play a role in determining patients[rsquo] QOL. In this open-label, multicenter study, quality of life instruments were used to derive data 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 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 453 patients with epilepsy were collected. QOLIE-31 (quality of life in epilepsy-31), and QOLIE-AD-48 (quality of life in epilepsy-adolescent-48) assessments were performed at baseline (month 0) and month 3. These assessments are validated, epilepsy-specific tools for use in adult and adolescent patients, respectively. They measure several areas of quality of life, including: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall QOL. Results of quality of life instruments from patients switched to CBZ-ERC showed significant improvement in total, as well as all subcategories of QOL assessed, for both adults ([italic]P[/italic]=.01), and adolescents ([italic]P[/italic]=.05). Patient-rated QOL scores indicated that switching from IR-CBZ to CBZ-ERC resulted in greater improvements in QOL. These scores take into account seizure worry, medication effects, emotional well-being, social functioning, energy/fatigue, cognitive functioning, and overall QOL. The data establish that patients switched to CBZ-ERC from IR-CBZ demonstrate better quality of life related to improvement in a wide range of variables. (Supported by Shire
Carbatrol is registered in the United States Patent and Trademark Office.)