Abstracts

Efficacy and tolerability of topiramate (TPM) have been established in several fixed dose trials, predominantly in patients with refractory partial epilepsy. The objective of this study was to evaluate the use of topiramate as early add-on therapy in recently recommended lower doses¹ under the conditions of daily clinical practice.
One-year prospective multicenter observational study in patients [ge]12 years of age with partial or generalized tonic-clonic seizures. Topiramate could be titrated individually to clinical response, concomitant antiepileptic drugs (AEDs) could be adjusted as deemed necessary. Visits were performed at baseline and after 1, 2, 3, 6, 9 and 12 months. Seizure frequency and adverse events (AEs) were assessed at each visit.
450 patients (52 % male, mean age 40.3 [plusmn] 17 years, median time since epilepsy diagnosis 2.6 years, mean follow-up period 343 [plusmn] 82 days) were enrolled. 56 patients (12.4 %) were older than 60 years. 67 % of all patients had partial seizures with or without secondary generalization, 33 % had generalized tonic-clonic seizures. The most frequently used concomitant AEDs were carbamazepine (54 %) and valproic acid (34 %). At endpoint, the median TPM dose was 200 mg/day. 58 % of the patients were successfully treated with doses of 200 mg TPM/day or less. Median seizure frequency in the 12 weeks prior to enrollment was 8.5. Median seizure reduction at endpoint was 74 % (p[lt]0.001 vs. baseline). The responder rate (defined as at least 50 % reduction in seizure frequency) was 72 %. No adverse event was reported in an incidence [ge]10 %. AEs reported [ge]5% were somnolence, dizziness, nausea, weight decrease, paraesthesia and depressive symptoms. Mean weight change was [ndash]1.6 kg over the 12-month period. 5.1 % of the patients discontinued treatment prematurely due to an adverse event, and 86.7 % continued treatment with topiramate beyond the one-year period.
In this study topiramate add-on was effective and well tolerated. Individual adjustment of topiramate doses and concomitant AEDs and particularly the use of recently recommended lower doses¹ most likely contributed to these results.
1 Guberman A, Neto W, Gassmann-Mayer C. Low-dose topiramate in adults with treatment-resistant partial-onset seizures. Acta Neurol Scand 2002;106:183-89
[Supported by: Janssen-Cilag Germany.]