Abstracts

To evaluate the long-term monotherapy with topiramate (TPM) in patients with epilepsy, independent of seizure type or epilepsy syndrome. Patients with epilepsy who had completed one of two uncontrolled multicenter open-label German TPM monotherapy studies were eligible for this 12-month prospective observational study. Patients were evaluated at the last visit of their previous 7-month trial and 3, 6, 9 and 12 months thereafter. 112 patients (51% male, mean age 43 [plusmn] 17 years, range 16[ndash]78 years) were followed for a median of 19 months (maximum 22.5 months). Seizure types in the last 12 weeks of the previous studies were generalized tonic-clonic (n=67), complex partial (n=21), simple partial (n=12) and absence seizures (n=3). At endpoint, the median TPM dose was 100 mg/day and 67% of the patients received [le]100 mg TPM/day. 73% of the patients remained seizure free for at least 12 months, and 94% were responders with a [ge] 50% seizure reduction. Mean seizure frequency decreased from 5.0/month at baseline to 0.8/month at endpoint. 6 patients (5.4%) discontinued the study prematurely due to an AE, 3 (2.7%) due to lack of efficacy. AEs reported in [ge] 5% were paraesthesia (12.3%), nausea (6.1%), somnolence (5.3%) and decreased appetite (5.3%). Topiramate long-term monotherapy in a selected group of patients with epilepsy who had completed one of two previous open-label trials was associated with a high seizure-free rate and well tolerated. Low drop-out rates due to lack of efficacy suggest a persistent long-term efficacy of TPM. (Supported by Janssen-Cilag Germany.)