Abstract

In this open-label, observational study, the safety and tolerability of topiramate monotherapy as well as changes in seizure frequency in elderly individuals (age ≥ 65 years) with newly or recently diagnosed epilepsy were documented. The study was conducted in 55 German neurological private practices and outpatient clinics between October 2003 and March 2005. A total of 145 patients were involved. A standardised case report form was used to document demographic data, history, epileptic syndrome, aetiology, number of concomitant medications, dose of topiramate, additional anticonvulsants, seizure frequency and adverse events at baseline, and at follow-up visits after 3 and 6 months, respectively. Duration since epilepsy diagnosis was approximately one year. Mean age was 73 years and 71 patients were women. 79 patients had symptomatic or cryptogenic focal epilepsy, 10 patients had cryptogenic or symptomatic generalized epilepsy, 56 patients were not classified. 93 % patients had a least one concomitant disease and about 90 % had at least one other medication. Topiramate doses ranged between 50 and 100 mg per day in most patients. At the end of the study, 40.7 % patients were seizure-free. In the per protocol group, the percentage of seizure free patients was slightly higher (42.7 %); the median duration of seizure freedom in this group was 185 days (range: 168 - 263). 5.5 % of patients had at least one adverse event (AE), and two patients discontinued treatment due to an AE. Our observational study is consistent with the results from recent clinical trials that topiramate in a naturalistic setting is well tolerated in elderly patients and renders a high proportion of patients seizure free.

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