Abstracts

Rationale: To describe long-term outcomes of topiramate treatment in epilepsy in both gender irrespective of seizure type or epilepsy syndrome (TOP-GER-11). Methods: Male and female 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, open-label, non-interventional trial. Patients were evaluated during their previous trial and after 3, 6, 9, and 12 months during this trial while on topiramate treatment with respect to seizure frequency, adverse events (AEs), and body mass index (BMI). A post-hoc gender-based analysis was added.Results: The ITT population encompassed 102 patients (51% male, mean age 43 +/- 17 years, range 16-78 years) were followed for a median of 19 months (maximum 22.5 months). Mean duration of epilepsy in men vs. women was 54 months (SD +/- 96) vs 68 months (SD +/- 138.2). AEDs used within the last 3 years prior to study inclusion showed a higher rate of CBZ use (33% vs 28%) for men and a higher use of VPA (14% vs 30%) in women in the preceding study. A higher preponderance for generalized epileptic syndromes was noted in women compared to men (66% vs 48%). Women were more likely to be 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%) than women. 58% of women (vs 38% of men) used concomitant medication. At endpoint, median dose of TPM was 100mg/day for both genders, which corresponded well to the doses used in the previous trial. 73% of patients were seizure free for at least 12 months with no gender differences. There was practically no change between response rates comparing results at final visit of the previous trials and final visit in the current trial. Mean BMI decreased from 26.05 kg/m2 (male subjects, SD +/- 3.6) to 25.73 kg/m2 (end initial trial) and 25.56 kg/m2 (long-term trial endpoint) (p<0.02). In women, BMI decreased from 26.86 kg/m2 (SD +/- 5.8) to 25.94 and 25.50 kg/m2 respectively (p<0.0001). 5% of patients discontinued the long-term study prematurely due to an AE, 3% due to lack of efficacy. AEs with at least possible causal relationship reported in 5% and similarly distributed between genders 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.