Abstracts

Topiramate is recognized as a broad-spectrum antiepileptic drug (AED), based on results from double-blind randomized controlled trials. Because these trials are often conducted for registration purposes, they tend to enroll relatively homogenous and more selected patient populations vs. those encountered in clinical practice. A large, open-label study evaluated topiramate monotherapy in the clinical practice setting. We report the results stratified by seizure type (partial-onset or generalized) and by whether patients were treatment-naive or failed previous therapy. Patients in whom epilepsy had been diagnosed [le]5 yrs before topiramate treatment were followed in an open-label, multicenter prospective study conducted in Europe and the Middle East. Patients were treatment-naive or had failed one antiepileptic drug (which was withdrawn when topiramate added). Doses were adjusted according to clinical response, with 3 mg/kg/day as the initial target dose for children 2-12 yrs and 100 mg/day for older children and adults (maximum, 9 mg/kg/day and 400 mg/day). Patients were followed for 7-13 mos. Responses were analyzed according to baseline seizure type, i.e., generalized and partial-onset. A total of 714 patients were enrolled; 690 had evaluable efficacy data. Data for 155 patients with generalized seizures (absence seizures excluded) and 431 with partial-onset seizures were analyzed. Mean baseline seizure frequency was 5.4 generalized seizures/mo and 7.7 partial-onset seizures/mo. Seizure were reduced [ge]50%, [ge]75%, and 100% in 89%, 80% and 63%, respectively, of patients with generalized seizures and 77%, 63% and 40%, respectively, in those with partial-onset seizures. Response rates were higher in therapy-naive patients. Changes from baseline were significant in all subgroups (p[lt]0.001). Topiramate was generally well tolerated, with paresthesia and headache as the most common adverse events. Generalized and partial-onset seizures responded well to topiramate monotherapy. Higher response rates in therapy-naive patients vs. those who had failed a previous AED are consistent with observations with other AEDs. (Supported by Janssen-Cilag)