title: Lacosamide in pediatric and adult patients: comparison of efficacy and safety.
abstract: OBJECTIVE
  This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy.
  
  
  METHODS
  This study was carried out between September 2010 and December 2011 at 16 Italian and 1 German neurologic centers. Lacosamide was added to the baseline therapy at a starting dose of 1 mg/kg/day in patients aged <16 years (group A) and 100 mg daily in subjects aged 16 and older (group B), and titrated to the target dose, ranging from 3 to 12 mg/kg/day or from 100 to 600 mg daily, respectively. After completing the titration period, patients entered a 12-month maintenance period and they were followed up at 3, 6 and 12 months. The primary assessment of efficacy was based on the change from baseline in seizure frequency per 28 days and was evaluated at 3, 6 and 12 months as follows: number and proportion of 100% responders, 50% responders, non-responders and worsening patients. Safety evaluation was also performed at 3, 6 and 12 months.
  
  
  RESULTS
  A total of 118 patients (59 group A, 59 group B) with uncontrolled generalized and focal epilepsy were enrolled. Patient mean±SD age was 15.9±6.80 years and the age range was 4-38 years. At 3-month evaluation, of 118 treated patients 56 subjects (47.4% group A; 47.4% group B; p=0.8537) experienced at least a 50% reduction in seizure frequency. At 6 and 12-month follow-up, the 50% responders were 57 (52.5% group A; 44.1% group B; p=0.4612) and 51 (47.4% group A; 39% group B; p=0.4573), respectively. Thirty-five subjects (30.5% group A; 28.8% group B; p=1) experienced side effects during the treatment period. The most common adverse events were dyspepsia for group A and dizziness for group B.
  
  
  CONCLUSIONS
  Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures.
authors.affiliation: Department of Paediatrics, University of Chieti, Chieti, Italy. averrott@unich.it
authors.forename: Alberto
authors.initials: A
authors.lastname: Verrotti
authors.forename: Giulia
authors.initials: G
authors.lastname: Loiacono
authors.forename: Antonella
authors.initials: A
authors.lastname: Pizzolorusso
authors.forename: Pasquale
authors.initials: P
authors.lastname: Parisi
authors.forename: Oliviero
authors.initials: O
authors.lastname: Bruni
authors.forename: Anna
authors.initials: A
authors.lastname: Luchetti
authors.forename: Nelia
authors.initials: N
authors.lastname: Zamponi
authors.forename: Silvia
authors.initials: S
authors.lastname: Cappanera
authors.forename: Salvatore
authors.initials: S
authors.lastname: Grosso
authors.forename: Gerhard
authors.initials: G
authors.lastname: Kluger
authors.forename: Christine
authors.initials: C
authors.lastname: Janello
authors.forename: Emilio
authors.initials: E
authors.lastname: Franzoni
authors.forename: Maurizio
authors.initials: M
authors.lastname: Elia
authors.forename: Alberto
authors.initials: A
authors.lastname: Spalice
authors.forename: Giangennaro
authors.initials: G
authors.lastname: Coppola
authors.forename: Pasquale
authors.initials: P
authors.lastname: Striano
authors.forename: Piero
authors.initials: P
authors.lastname: Pavone
authors.forename: Salvatore
authors.initials: S
authors.lastname: Savasta
authors.forename: Maurizio
authors.initials: M
authors.lastname: Viri
authors.forename: Antonino
authors.initials: A
authors.lastname: Romeo
authors.forename: Paolo
authors.initials: P
authors.lastname: Aloisi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gobbi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ferretti
authors.forename: Raffaella
authors.initials: R
authors.lastname: Cusmai
authors.forename: Paolo
authors.initials: P
authors.lastname: Curatolo
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D016896:Treatment Outcome
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide