Abstracts

The objective of this study was to evaluate the efficacy and tolerability of topiramate (TPM) in the monotherapy of patients with epilepsy after switching from valproate (VPA). Interim analysis of a multicenter open-label non-interventional study. Patients with epilepsy [ge] 12 years of age who were previously unsuccessfully treated with VPA due to lack of efficacy and/or lack of tolerability were prospectively followed for 20 weeks after initiation of, and switch to TPM. 61 patients (64% female, mean age 43[plusmn]18 years, median time since epilepsy diagnosis 7.5 years) were enrolled. The most frequent seizure types at baseline were generalized tonic-clonic (46%) and complex partial (25%). Reasons for VPA discontinuation were lack of efficacy (54%) and side effects (89%) (tremor (57%), weight gain (55%) and cognitive symptoms (40%). For patients reaching the endpoint, included in this interim analysis the median TPM dose was 100 mg/day (range 25-250 mg/day); 23% of patients received less than 100 mg TPM/day. Median seizure frequency decreased from 2.0/month at baseline to 0.7/month at endpoint. The responder rate ([ge] 50 % reduction in seizure frequency) was 73%. 42% of the patients remained seizure free. 90% of all patients completed the study, 5% discontinued TPM prematurely due to an adverse event (AE). The only AE reported in [ge] 4% was fatigue (4.9%). After switching from VPA, topiramate was associated with a substantial seizure reduction and few side effects. The median TPM dose was 100mg/day b.i.d. (Supported by Janssen-Cilag Germany.)