Abstracts

The objective of this study was to evaluate flexible doses of topiramate (TPM) in the monotherapy of epilepsy independent of seizure type or epilepsy syndrome. Prospective open-label multicenter phase IV study. Adult patients with recently diagnosed epilepsy ([lt] 3 years), previously untreated or unsuccessfully treated with one antiepileptic drug, were evaluated at baseline and after 6, 16 and 30 weeks. In previously treated patients, transition to TPM monotherapy had to be established within 6 weeks after enrollment. 213 patients (56% male, mean age 40[plusmn]16 years, range 18 - 88 years) were enrolled. 50.5% of the patients had partial epilepsy, 40.5% had generalized epilepsy, 6.3% had a specific epilepsy syndrome, and 2.6% remained unclassified. At endpoint, the mean topiramate dose was 117 mg/day. 78.4% of the patients received 100 mg/TPM per day or less. Mean seizure frequency decreased from 5.4 in the 12 weeks prior to enrollment to 2.5 at endpoint (p[lt]0.0001). 57.9% of the patients remained seizure free during the 7-months study, and 76.8% were responders with a = 50% reduction in seizure frequency. Adverse events reported in = 5% were paraesthesia (15.3%), somnolence (8.3%) and dizziness (5.8%). 4.2% of the patients dropped out due to side effects. 77.5% continued TPM treatment beyond the study. Topiramate monotherapy in patients with recently diagnosed epilepsy was associated with a significant reduction in seizure frequency, independent of seizure type or epilepsy syndrome. Doses of [sim]100 mg/TPM day in this study were well tolerated. (Supported by Janssen-Cilag Germany)