Is Topiramate Tops?

Glauser TA, Dlugos DJ, Dodson WE, Grinspan A, Wang S, Wu SC; EPMN‐106/INT‐28 Investigators. J Child Neurol 2007;22(6):693–699. A double‐blind, dose‐controlled study evaluated topiramate as monotherapy in 470 patients with newly diagnosed (3 months) epilepsy or epilepsy relapse in the absence of therapy. In addition to having at least 2 lifetime‐unprovoked seizures, patients had 1 or 2 partial‐onset seizures or generalized‐onset tonic‐clonic seizures during a 3‐month retrospective baseline. The trial included a large cohort (N = 151, 32%) of children and adolescents 6 to 15 years of age. Eligible patients were randomized to treatment groups in which topiramate was titrated to target maintenance dosages of either 400 mg/day (n = 77) or 50 mg/day (n = 74). Patients were followed for at least 6 months. Based on Kaplan‐Meier analyses, the primary efficacy endpoint of time to first seizure favored the higher topiramate dose in both the overall population and the cohort of children/adolescents. The probability that children/adolescents remaining in the study were seizure free at 6 months was 78% in the 50‐mg target dose group and 90% with the higher dose. At 12 months, the probability of being seizure free was 62% and 85%, respectively. The incidence of treatment‐limiting adverse events was 4% in the 50‐mg target dose group and 14% in the group assigned to 400 mg as a target dose. The most common adverse events, excluding typical childhood illnesses, were headache, appetite decrease, weight loss, somnolence, dizziness, concentration/attention difficulty, and paresthesia. As shown in this subset analysis, topiramate is effective and well tolerated as monotherapy in children and adolescents.