Long-term treatment with topiramate monotherapy in epilepsy

Rationale: To describe long-term outcomes of topiramate (TPM) treatment in epilepsy (TOP-GER-11).

Methods: Subjects with a diagnosis of epilepsy (ILAE, 1989) who had completed one of two recent trials with topiramate (TOP-GER-5 and TOP-GER-12) were eligible for this 12-month prospective, non-interventional trial. Patients were evaluated during their previous trial and after 3, 6, 9, and 12 months during this trial (seizure frequency, adverse events [AE]). A post-hoc gender-based analysis was added.

Results: Median follow up was 19 months (ITT=102 patients, 51% male, mean age 43±17). Mean duration of epilepsy in men vs. women was 54 months (SD±96) vs. 68 months (SD±138.2). Generalized epileptic syndromes were more frequent in women than men (66% vs. 48%). More women switched due to side effects (50% vs. 35%) or lack of efficacy (48% vs. 25%). Initial TPM monotherapy was more frequent in men (52% vs. 36%). Median dose of TPM was 100mg/day for both genders unchanged from previous trials. 73% of patients were seizure free for at least 12 months with no gender differences. There was no difference in response between final visits. 5% of patients discontinued the long-term study prematurely due to an AE, 3% due to lack of efficacy. Treatment related AEs were paresthesias (12%), nausea (6%), somnolence (5%), decreased appetite (5%) and memory-/concentration- disturbances (6%).

Conclusions: Long term monotherapy with topiramate resulted in sustained seizure reduction in both men and women. In addition topiramate doses remained generally unchanged and topiramate was well tolerated in both gender.