Short-term efficacy and safety of zonisamide as adjunctive treatment for refractory partial seizures: A multicenter open-label single-arm trial in Korean patients

Title
Short-term efficacy and safety of zonisamide as adjunctive treatment for refractory partial seizures: A multicenter open-label single-arm trial in Korean patients
Author(s)
허 경 [허 경 ]이병인[이병인]예상도[예상도]조영원[조영원]신동진[신동진]송홍기[송홍기]김옥준[김옥준]박성파[박성파]김성은[김성은]김성호[김성호]이준홍[이준홍]김규식[김규식]이세진
Keywords
PARTIAL-ONSET SEIZURES; ANTIEPILEPTIC DRUGS; PARTIAL EPILEPSY; DOUBLE-BLIND; PHARMACOKINETICS; THERAPY
Issue Date
201204
Publisher
W B SAUNDERS CO LTD
Citation
SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, v.21, no.3, pp.188 - 193
Abstract
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 100 mg/day, and was increased to 200 mg/day after 2 weeks. During the 12-week maintenance period, the dose of ZNS was adjusted to 200-400 mg/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. (C) 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
URI
http://hdl.handle.net/YU.REPOSITORY/28713http://dx.doi.org/10.1016/j.seizure.2011.12.005
ISSN
1059-1311
Appears in Collections:
의과대학 > 신경과학교실 > Articles
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