Document Detail


Rufinamide in children and adults with Lennox-Gastaut syndrome: first Italian multicenter experience.
MedLine Citation:
PMID:  20888268     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This is the first multicenter Italian experience with rufinamide as an adjunctive drug in children, adolescents and adults with Lennox-Gastaut syndrome. The patients were enrolled in a prospective, add-on, open-label treatment study from 11 Italian centers for children and adolescent epilepsy care. Forty-three patients (26 males, 17 females), aged between 4 and 34 years (mean 15.9 ± 7.3, median 15.0), were treated with rufinamide for a mean period of 12.3 months (range 3-21 months). Twenty patients were diagnosed as cryptogenic and 23 as symptomatic. Rufinamide was added to the baseline therapy at the starting dose of 10mg/kg body weight, evenly divided in two daily doses and then increased by 10mg/kg approximately every 3 days up to a maximum of 1000 mg/day in children aged ≥4 years with a body weight less than 30 kg. In patients more than 30 kg body weight, rufinamide could be titrated up to 3200 mg/day. After a mean follow-up period of 12.3 months (range 3-21 months), the final mean dose of rufinamide was 33.5mg/kg/24h (range 11.5-60) if combined to valproic acid, and of 54.5mg/kg/24h (range 21.8-85.6) without valproic acid. The response rate (≥50% decrease in countable seizures) was 60.5% (26 of 45 patients) in total; 51.1% experienced a 50-99% reduction in seizure frequency and complete seizure control was achieved in the last 4 weeks follow-up by 9.3% of patients. Two patients (4.7%) had a 25-50% seizure reduction, while seizure frequency remained unchanged in 13 (30.2%) and increased in 2 (4.7%). Reliable data for atypical absence seizures and myoclonic seizures were not available, as these are usually impossible to count. Ten patients (23.2%) reported adverse side effects, while taking rufinamide. They were generally mild and transient and most frequently included vomiting, drowsiness, irritability and loss of appetite. In conclusion, rufinamide as an adjunctive therapy reduced the number of drop attacks and major motor seizures in about 60% of patients with Lennox-Gastaut syndrome and produced only mild or moderate adverse side effects.
Authors:
Giangennaro Coppola; Salvatore Grosso; Emilio Franzoni; Pierangelo Veggiotti; Nelia Zamponi; Pasquale Parisi; Alberto Spalice; Francesco Habetswallner; Antonio Fels; Giuseppe Capovilla; Alberto Verrotti; Salvatore Mangano; Alberto Balestri; Paolo Curatolo; Antonio Pascotto
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Seizure : the journal of the British Epilepsy Association     Volume:  19     ISSN:  1532-2688     ISO Abbreviation:  Seizure     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-18     Completed Date:  2011-01-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9306979     Medline TA:  Seizure     Country:  England    
Other Details:
Languages:  eng     Pagination:  587-91     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Affiliation:
Clinic of Child Neuropsychiatry, Second University of Naples, Naples, Italy. gianegennaro.coppola@unina2.it
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Anticonvulsants / administration & dosage,  adverse effects,  therapeutic use*
Child
Child, Preschool
Drug Therapy, Combination
Female
Humans
Italy
Male
Mental Retardation / drug therapy
Spasms, Infantile / drug therapy
Treatment Outcome
Triazoles / administration & dosage,  adverse effects,  therapeutic use*
Valproic Acid / administration & dosage,  therapeutic use
Young Adult
Chemical
Reg. No./Substance:
0/Anticonvulsants; 0/Triazoles; 106308-44-5/rufinamide; 99-66-1/Valproic Acid

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


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