Document Detail

Short-term efficacy and safety of zonisamide as adjunctive treatment for refractory partial seizures: a multicenter open-label single-arm trial in Korean patients.
MedLine Citation:
PMID:  22226572     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the efficacy and safety of adjunctive zonisamide (ZNS) therapy in Korean adults with uncontrolled partial epilepsy.
METHODS: Study patients had an average of at least one seizure per 4-week (averaged over a 12-week historical baseline) despite the use of one to three antiepileptic drugs. The starting dose of ZNS was 100mg/day, and was increased to 200mg/day after 2weeks. During the 12-week maintenance period, the dose of ZNS was adjusted to 200-400mg/day based on the physicians' discretion. The global evaluation scale (GES) and quality of life (QOLIE-31) were also evaluated.
RESULTS: A total of 121 patients were enrolled, of which 88 patients completed the study. The median percent reduction in weekly seizure frequency over the treatment period was 59.0%. The ≥50% and ≥75% responder rates were 57.3% and 38.5%, respectively. Seizure freedom over the treatment period was observed in 25 patients, but seizure freedom throughout the 16-week treatment period was attained in only 16 patients. On investigator's GES, 84 patients were considered improved, with 33 patients showing marked improvement. In QOLIE-31 scale, seizure worry improved significantly but emotional well-being deteriorated. Treatment-emergent adverse events (AEs) were reported in 80 patients. The most common AEs were dizziness (28.1%), somnolence (24.0%), anorexia (18.2%), headache (14.0%), nausea (13.2%), and weight loss (10.7%). Twenty-two patients discontinued the trial due to drug-related AEs.
CONCLUSIONS: Our results suggest that adjunctive ZNS therapy for the treatment of refractory partial epilepsy, though efficacious, is associated with significant tolerability problems.
Kyoung Heo; Byung In Lee; Sang Do Yi; Yong Won Cho; Dong Jin Shin; Hong Ki Song; Ok Joon Kim; Sung-Pa Park; Sung Eun Kim; Sang Ho Kim; Jun Hong Lee; Kyu-Sik Kim; Se-Jin Lee
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-01-04
Journal Detail:
Title:  Seizure     Volume:  21     ISSN:  1532-2688     ISO Abbreviation:  Seizure     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-03-06     Completed Date:  2012-07-23     Revised Date:  2014-10-21    
Medline Journal Info:
Nlm Unique ID:  9306979     Medline TA:  Seizure     Country:  England    
Other Details:
Languages:  eng     Pagination:  188-93     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
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MeSH Terms
Anticonvulsants / administration & dosage*,  adverse effects
Dose-Response Relationship, Drug
Epilepsies, Partial / drug therapy*
Isoxazoles / administration & dosage*,  adverse effects
Middle Aged
Seizures / drug therapy*
Young Adult
Reg. No./Substance:
0/Anticonvulsants; 0/Isoxazoles; 68291-97-4/zonisamide

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

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