Abstracts

To evaluate seizure frequency and tolerability in patients with epilepsy treated with topiramate (TPM) transitioning from valproic acid (VPA)., Multicenter open-label non-interventional study. Patients [ge] 12 years of age with epilepsy previously unsuccessfully treated with VPA were prospectively followed for 20 weeks after transition to TPM. A 12 week retrospective seizure frequency was used as baseline., 147 patients (59% female; mean age 42 year ([underline][plusmn][/underline]SD 19)) were identified. Median duration of epilepsy was 9 years (range, 0-60 years). 77% had seizures during the 12 weeks retrospective baseline. Most frequent seizure types at baseline were generalized tonic-clonic (52%), complex partial (23%), and simple partial (12%). Main reasons provided for transitioning from VPA to TPM were insufficient efficacy (61%) and/or side effects (81%). Side effects listed as reason for transitioning ([ge]10%) were weight gain (37%), tremor (29%), fatigue (21%), hair loss (12%) cognitive disorder, hepatic function abnormalities or nausea (10% each).
At endpoint, the median TPM dose was 125mg/day. Mean seizure frequency decreased significantly from 32 ([underline][plusmn][/underline]SD 248) seizures per month during the retrospective baseline to 3 ([underline][plusmn][/underline]SD 16) seizures / month during the maintenance period (p[lt]0.001). The responder rate ([ge] 50 % seizure reduction) during the maintenance period was 75%, and 51% patients remained seizure-free during this period. 16% of patients discontinued TPM, 8% due to an adverse event (AE), and 3% due to insufficient efficacy. Treatment-emergent adverse events (TEAE) were reported in 14% of patients. TEAE occurring [ge] 3 % were paraesthesia (4%) and weight decrease (5%). 70% of patients were on TPM monotherapy at the end of the observation and 77% continued on TPM therapy., After transition from VPA, topiramate was associated with a substantial reduction in seizure frequency, including a high seizure-free rate, and was well tolerated., (Supported by Janssen-Cilag Germany.)