title: Efficacy and safety of felbamate in children under 4 years of age: a retrospective chart review.
abstract: OBJECTIVE
  To review our experience of the efficacy and tolerability of felbamate in children younger than 4 years.
  
  
  METHODS
  We used a retrospective chart review to identify 53 children with seizures who were younger than 4 years. Efficacy was evaluated based on the occurrence of responsiveness, defined as seizure frequency reduction of more than 50% for a minimum period of 4 months. Tolerability was based on parent-reported side effects.
  
  
  RESULTS
  Twenty-two (41%) patients resulted to be responders and 31 (59%) did not. By univariate analysis, those achieving seizure remission were probably much older, to have a shorter history of epilepsy and a lower frequency of seizures before felbamate therapy. The number of antiepileptic drugs (AEDs) used before felbamate therapy was the only significant predictor of the duration of response to felbamate, with a longer responsiveness to the drug seen in those who were placed under fewer than three AEDs before felbamate compared with those who had taken more than three (median, 16 months vs. 7 months; P < 0.0084). Side effects occurred in 30% of the subjects, but these did not require discontinuation of the drug.
  
  
  CONCLUSIONS
  Felbamate is an effective medication for a wide range of epilepsy syndromes in children younger than 4 years. Although caution is necessary when the drug is used in children, felbamate might represent a possible option for the treatment of epilepsy in this age group.
authors.affiliation: Pediatric Neurology Section, Department of Pediatrics, University of Siena, Siena, Italy. grosso@unisi.it
authors.forename: S
authors.initials: S
authors.lastname: Grosso
authors.forename: D Maria
authors.initials: DM
authors.lastname: Cordelli
authors.forename: G
authors.initials: G
authors.lastname: Coppola
authors.forename: E
authors.initials: E
authors.lastname: Franzoni
authors.forename: A
authors.initials: A
authors.lastname: Verrotti
authors.forename: R
authors.initials: R
authors.lastname: Berardi
authors.forename: P
authors.initials: P
authors.lastname: Balestri
mesh_terms: D000855:Anorexia / Q000139:chemically induced; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D004341:Drug Evaluation; D004351:Drug Resistance; D004827:Epilepsy / Q000188:drug therapy*; D000078328:Felbamate; D005260:Female; D006801:Humans; D007223:Infant; D053609:Lethargy / Q000139:chemically induced; D008297:Male; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D048448:Phenylcarbamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012893:Sleep Wake Disorders / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D048448:Phenylcarbamates; D011409:Propylene Glycols; D000078328:Felbamate