title: Efficacy and safety of topiramate in infants according to epilepsy syndromes.
abstract: Studies of the efficacy of topiramate (TPM) in infants and young children are few. Here we report an open, prospective, and pragmatic study of effectiveness of TPM in terms of epilepsy syndromes, in children aged less than 2 years. The median follow-up period was 11 months. We enrolled 59 children in the study: 22 affected by localization-related epilepsy (LRE), 23 by generalized epilepsy, six by Dravet's syndrome, and eight with unclassifiable epilepsy. TPM was effective (responders showed a decrease of more than 50% in seizure frequency) in 47% of patients, including 13% who were seizure-free at the last visit. TPM was more effective in localization-related epilepsy (48% of responders) than in generalized epilepsy (32% of responders). In the latter group, 19 patients suffered from infantile spasms. Four of six patients with cryptogenic infantile spasms became seizure-free. Of the 13 patients with symptomatic infantile spasms, only one was seizure-free. Results were poor for patients with Dravet's syndrome. In general, TPM was well tolerated. The most frequently reported adverse effects were drowsiness, irritability, hyperthermia, and anorexia. The present study concludes that TPM is effective for a broad range of seizures in infants and young children and represents a valid therapeutic option in this population.
authors.affiliation: Department of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Via M. Bracci, Le Scotte 53100, Siena, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Grosso
authors.forename: D
authors.initials: D
authors.lastname: Galimberti
authors.forename: M A
authors.initials: MA
authors.lastname: Farnetani
authors.forename: M
authors.initials: M
authors.lastname: Cioni
authors.forename: R
authors.initials: R
authors.lastname: Mostardini
authors.forename: R
authors.initials: R
authors.lastname: Vivarelli
authors.forename: R M
authors.initials: RM
authors.lastname: Di Bartolo
authors.forename: E
authors.initials: E
authors.lastname: Bernardoni
authors.forename: R
authors.initials: R
authors.lastname: Berardi
authors.forename: G
authors.initials: G
authors.lastname: Morgese
authors.forename: P
authors.initials: P
authors.lastname: Balestri
mesh_terms: D000855:Anorexia / Q000139:chemically induced; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004827:Epilepsy / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012189:Retrospective Studies; D012894:Sleep Stages / Q000187:drug effects; D013035:Spasm / Q000188:drug therapy / Q000209:etiology; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose