PMID- 22226572 OWN - NLM STAT- MEDLINE DCOM- 20120723 LR - 20181201 IS - 1532-2688 (Electronic) IS - 1059-1311 (Linking) VI - 21 IP - 3 DP - 2012 Apr TI - Short-term efficacy and safety of zonisamide as adjunctive treatment for refractory partial seizures: a multicenter open-label single-arm trial in Korean patients. PG - 188-93 LID - 10.1016/j.seizure.2011.12.005 [doi] AB - 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. CI - Copyright A(c) 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved. FAU - Heo, Kyoung AU - Heo K AD - Department of Neurology, Severance Hospital, Seoul, Republic of Korea. FAU - Lee, Byung In AU - Lee BI FAU - Yi, Sang Do AU - Yi SD FAU - Cho, Yong Won AU - Cho YW FAU - Shin, Dong Jin AU - Shin DJ FAU - Song, Hong Ki AU - Song HK FAU - Kim, Ok Joon AU - Kim OJ FAU - Park, Sung-Pa AU - Park SP FAU - Kim, Sung Eun AU - Kim SE FAU - Kim, Sang Ho AU - Kim SH FAU - Lee, Jun Hong AU - Lee JH FAU - Kim, Kyu-Sik AU - Kim KS FAU - Lee, Se-Jin AU - Lee SJ LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20120104 PL - England TA - Seizure JT - Seizure JID - 9306979 RN - 0 (Anticonvulsants) RN - 0 (Isoxazoles) RN - 459384H98V (Zonisamide) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anticonvulsants/*administration & dosage/adverse effects MH - Dose-Response Relationship, Drug MH - Epilepsies, Partial/*drug therapy MH - Female MH - Humans MH - Isoxazoles/*administration & dosage/adverse effects MH - Korea MH - Male MH - Middle Aged MH - Seizures/*drug therapy MH - Young Adult MH - Zonisamide EDAT- 2012/01/10 06:00 MHDA- 2012/07/24 06:00 CRDT- 2012/01/10 06:00 PHST- 2011/09/27 00:00 [received] PHST- 2011/12/06 00:00 [revised] PHST- 2011/12/08 00:00 [accepted] PHST- 2012/01/10 06:00 [entrez] PHST- 2012/01/10 06:00 [pubmed] PHST- 2012/07/24 06:00 [medline] AID - S1059-1311(11)00317-7 [pii] AID - 10.1016/j.seizure.2011.12.005 [doi] PST - ppublish SO - Seizure. 2012 Apr;21(3):188-93. doi: 10.1016/j.seizure.2011.12.005. Epub 2012 Jan 4.