Abstracts

We examined the demographics and clinical characteristics, including seizure frequency, CBZ dose and range, as well as epilepsy duration, in patients enrolled to date in a multicenter, open label study assessing the efficacy and safety of switching from an immediate-release carbamazepine (Tegretol) to an extended-release CBZ (Carbatrol).
Patient data on demographic information, medical and medication background, and seizure history was collected and analyzed. Patients were asked to indicate the frequency and type of seizures experienced during the past month and to disclose their epilepsy duration. Investigators gathered information on the subject[rsquo]s prior use of CBZ including dose/regimen, duration of use, and current brand/formulation. Inclusion criteria for this study required subjects, male or female, to be 12 years of age or older at the time of study entry, female subjects may not be pregnant, and women of childbearing potential agree to protect against conception. In addition, subjects should be diagnosed with history of partial epilepsy, currently prescribed IR-CBZ for at least 3 months prior to screening, and are not taking more than one concomitant antiepileptic drug (AED). All statistical analyses were carried out using SAS Windows (version 8.0).
Of the 236 patients currently enrolled to date in the study, 51.3% are female. Subject race was 73.7% Caucasian, 12.5% Black, 8.2% Hispanic, 2.6% Asian/pacific islander, 2.2% Native American, and 0.9% listed as other. The average age among enrolled subjects was 42.6 [plusmn] 16.8 years of age and the mean CBZ dose at screening was 737.0 [plusmn] 284.5 mg/day. The mean seizure frequency for all patients was 1.95 [plusmn] 5.97 per month and complex partial seizures were the most frequently reported (1.33 [plusmn] 5.18). 66.3% of patients had epilepsy for greater than 10 years, 13.1% had epilepsy for 6 to 10 years, 16.1% had epilepsy for 1 to 5 years and 4.5% had epilepsy for less than 1 year. Using Spearman[rsquo]s rank order correlation, a statistically significant ([italic]P[/italic]=.0014) positive correlation was found between increasing CBZ dose and epilepsy duration.
We have analyzed the demographic and clinical data from a cohort of patients enrolled to date in a multicenter, open label study assessing the safety and efficacy of switching from IR-CBZ to ER-CBZ (Carbatrol). A correlation exists between CBZ dose and epilepsy duration among these patients.
[Supported by: Study funded by an unrestricted grant by Shire US Inc.]