Abstracts

Rationale: To explore seizure outcomes and tolerability of topiramate (TPM) in mono- or combination therapy in elderly patients with epilepsy with either new onset (NOE) or longer duration epilepsy (LDE). Methods: Prospective, multicenter phase IV clinical trial (TOP-GER-13) enrolling patients >=60 years for 12 months. Doses of TPM and concomitant antiepileptic drugs could be adjusted individually. Seizure frequency and adverse events were documented at each visit. Results: 107 patients (53% male, mean age 69 ± 7 years) enrolled. 52 patients had NOE (disease duration <1 year) with a median baseline seizure frequency of 0.83 / 4 weeks (interquartile range (IQR) 0.67-1.83) and 1.33 / 4 weeks (IQR 0.67-2.33) in patients with LDE (>=1 year). At endpoint, mean TPM monotherapy dose was 98 mg/day and 153 mg/day as add-on. Median seizure frequency / 4 weeks decreased to 0 in NOE (IQR 0-0.47) and 0.14 in LDE (IQR 0-0.84); both p<0.0001 versus baseline. Differences in baseline and absolute seizure frequency change between groups (NOE vs LDE) were non-significant (p>0.05). However, 58.8% of patients with NOE were seizure free throughout the trial which contrasts to 29.4% of patients being seizure free in the LDE group (p=0.005, Fisher's exact-test). 43% had at least one treatment-emergent adverse event (TEAE). TEAEs >=5% were somnolence (9.4%), dizziness (7.5%), paraesthesia (5.6%), memory disturbance (5.6%) and depression (5.6%). Conclusions: In elderly patients with epilepsy, Topirmate was well tolerated and associated with a high number of seizure free patients which was highest among patients with recent onset epilepsy.