Document Detail

Lacosamide in pediatric and adult patients: comparison of efficacy and safety.
MedLine Citation:
PMID:  23298605     Owner:  NLM     Status:  MEDLINE    
PURPOSE: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy.
METHOD: 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.
CONCLUSION: Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures.
Alberto Verrotti; Giulia Loiacono; Antonella Pizzolorusso; Pasquale Parisi; Oliviero Bruni; Anna Luchetti; Nelia Zamponi; Silvia Cappanera; Salvatore Grosso; Gerhard Kluger; Christine Janello; Emilio Franzoni; Maurizio Elia; Alberto Spalice; Giangennaro Coppola; Pasquale Striano; Piero Pavone; Salvatore Savasta; Maurizio Viri; Antonino Romeo; Paolo Aloisi; Giuseppe Gobbi; Alessandro Ferretti; Raffaella Cusmai; Paolo Curatolo
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study     Date:  2013-01-05
Journal Detail:
Title:  Seizure     Volume:  22     ISSN:  1532-2688     ISO Abbreviation:  Seizure     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-11     Completed Date:  2013-08-26     Revised Date:  2014-10-27    
Medline Journal Info:
Nlm Unique ID:  9306979     Medline TA:  Seizure     Country:  England    
Other Details:
Languages:  eng     Pagination:  210-6     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
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MeSH Terms
Acetamides / administration & dosage,  adverse effects,  therapeutic use*
Anticonvulsants / administration & dosage,  adverse effects,  therapeutic use*
Child, Preschool
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Epilepsy / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Acetamides; 0/Anticonvulsants; 0/lacosamide
Erratum In:
Seizure. 2014 Apr;23(4):325

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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