A randomized, open-label, multicenter comparative trial of levetiracetam and topiramate as adjunctive treatment for patients with focal epilepsy in Korea
DC Field | Value | Language |
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dc.contributor.author | Lee, Sang Kun | - |
dc.contributor.author | Le, Sang Ahm | - |
dc.contributor.author | Kim, Dong Wook | - |
dc.contributor.author | Loesch, Christian | - |
dc.contributor.author | Pelgrims, Barbara | - |
dc.contributor.author | Osakabe, Toru | - |
dc.contributor.author | Lee, Byungin | - |
dc.contributor.author | Cho, Yong-Won | - |
dc.contributor.author | Park, Sung-Pa | - |
dc.contributor.author | Heo, Kyoung | - |
dc.contributor.author | Hong, Bong Seung | - |
dc.contributor.author | Kim, Dong-Wook | - |
dc.contributor.author | Kim, Ji Hyun | - |
dc.contributor.author | Song, Hong-Ki | - |
dc.contributor.author | Shon, Young Min | - |
dc.contributor.author | Kim, Young In | - |
dc.contributor.author | Kim, Woo Jun | - |
dc.contributor.author | Kim, Bo Mi | - |
dc.contributor.author | Fang, Sang-Hyun | - |
dc.contributor.author | Kim, Jae Moon | - |
dc.contributor.author | Ji, KiHwan | - |
dc.contributor.author | Kim, Sang-Ho | - |
dc.contributor.author | Kim, Sung Eun | - |
dc.contributor.author | Son, Je Yong | - |
dc.contributor.author | No, Soon Kee | - |
dc.contributor.author | Kim, Kwang-Ki | - |
dc.contributor.author | Song, Pamela | - |
dc.contributor.author | Park, Hee Kyung | - |
dc.contributor.author | Kim, Myeong Kyu | - |
dc.contributor.author | Kim, Joo-Yong | - |
dc.contributor.author | Kim, OkJoon | - |
dc.contributor.author | Lee, Eun Mi | - |
dc.contributor.author | Lim, Sung-Chul | - |
dc.contributor.author | Shin, Dong-Jin | - |
dc.date.accessioned | 2021-09-01T11:02:28Z | - |
dc.date.available | 2021-09-01T11:02:28Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2019-08 | - |
dc.identifier.issn | 1525-5050 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/64042 | - |
dc.description.abstract | Objective: The objective of this trial was to compare the effectiveness of levetiracetam (LEV) and topiramate (TPM) as adjunctive treatment for patients with focal seizures in Korea. Methods: In this Phase IV, open-label, multicenter trial (NCT01229735), adults were randomized to treatment with LEV (1000-3000 mg/day) or TPM (200-400 mg/day). Only patients achieving LEV >= 1000 mg/day or TPM >= 100 mg/day after a 4-week up-titration entered the 20-week dose-finding and subsequent 28-week maintenance periods. The primary outcome was the 52-week retention rate; others included safety and exploratory efficacy outcomes. Results: Of343 randomized patients (LEV 177; TPM 166), 211 (61.5%) completed the trial. In the full analysis set (FAS), retention rate was 59.1% with LEV vs 56.6% with TPM (p = 0.7007), while in the prespecified sensitivity analysis, based on data from patients who received drug doses in the recommended range (LEV 176; TPM 113), it was 59.1% with LEV vs 42.5% with TPM (p = 0.0086). In the FAS, median percent reduction in seizure frequency from baseline was 74.47% with LEV and 67.86% with TPM (p = 0.0665); 50% responder rate was 69.0% vs 64.8% (p = 0.4205), and the 6-month seizure-freedom rate was 35.8% vs 22.3% (p = 0.0061). In the sensitivity analysis, differences between groups were greater, favoring LEV. Incidences of treatment-emergent adverse events (TEAEs) were 70.6% with LEV vs 77.1% with TPM; most frequently somnolence (20.3%), dizziness (18.1%), and nasopharyngitis (13.6%) with LEV; and decreased appetite (15.7%), dizziness (14.5%), and headache (145%) with TPM. Discontinuations due to TEAEs were 7.9% with LEV and 12.7% with TPM. Conclusions: In this open-label trial, the 52-week retention rate was not significantly different between LEV and TPM. However, LEV was associated with a substantially higher seizure freedom rate and a more favorable safety profile than TPM in this population of Korean patients with focal seizures. (C) 2019 Published by Elsevier Inc. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ACADEMIC PRESS INC ELSEVIER SCIENCE | - |
dc.subject | LONG-TERM RETENTION | - |
dc.subject | ANTIEPILEPTIC DRUGS | - |
dc.subject | RATES | - |
dc.subject | EFFICACY | - |
dc.subject | ADULTS | - |
dc.subject | TOLERABILITY | - |
dc.subject | SAFETY | - |
dc.title | A randomized, open-label, multicenter comparative trial of levetiracetam and topiramate as adjunctive treatment for patients with focal epilepsy in Korea | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Ji Hyun | - |
dc.identifier.doi | 10.1016/j.yebeh.2019.05.014 | - |
dc.identifier.wosid | 000481571500010 | - |
dc.identifier.bibliographicCitation | EPILEPSY & BEHAVIOR, v.97, pp.67 - 74 | - |
dc.relation.isPartOf | EPILEPSY & BEHAVIOR | - |
dc.citation.title | EPILEPSY & BEHAVIOR | - |
dc.citation.volume | 97 | - |
dc.citation.startPage | 67 | - |
dc.citation.endPage | 74 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Behavioral Sciences | - |
dc.relation.journalResearchArea | Neurosciences & Neurology | - |
dc.relation.journalResearchArea | Psychiatry | - |
dc.relation.journalWebOfScienceCategory | Behavioral Sciences | - |
dc.relation.journalWebOfScienceCategory | Clinical Neurology | - |
dc.relation.journalWebOfScienceCategory | Psychiatry | - |
dc.subject.keywordPlus | LONG-TERM RETENTION | - |
dc.subject.keywordPlus | ANTIEPILEPTIC DRUGS | - |
dc.subject.keywordPlus | RATES | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | ADULTS | - |
dc.subject.keywordPlus | TOLERABILITY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordAuthor | Partial-onset seizures | - |
dc.subject.keywordAuthor | Antiepileptic drugs | - |
dc.subject.keywordAuthor | Add-on | - |
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