Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial
DC Field | Value | Language |
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dc.contributor.author | Kim, Ji Hyun | - |
dc.contributor.author | Lee, Sang Kun | - |
dc.contributor.author | Loesch, Christian | - |
dc.contributor.author | Namgoong, Kyungsun | - |
dc.contributor.author | Lee, Hyang Woon | - |
dc.contributor.author | Hong, Seung Bong | - |
dc.date.accessioned | 2021-09-03T08:09:53Z | - |
dc.date.available | 2021-09-03T08:09:53Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-04 | - |
dc.identifier.issn | 0013-9580 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/84081 | - |
dc.description.abstract | This open-label, multicenter, randomized phase IV trial (NCT01498822) of noninferiority design compared the long-term effectiveness, safety, and tolerability of levetiracetam (LEV) monotherapy with those of oxcarbazepine (OXC) monotherapy in adults with newly diagnosed focal epilepsy. Korean patients (16-80years), with 2 unprovoked focal seizures in the year preceding the trial, who had not taken any antiepileptic drugs (AEDs) in the last 6months, were randomized to receive LEV or OXC (1:1). Effectiveness, safety, and tolerability were assessed over a 50-week period. Treatment failure rates (per protocol set) were 15/118 (12.7%) in the LEV-treated group and 30/128 (23.4%) in the OXC-treated group, an absolute difference of -10.7% (95% confidence interval [CI] -20.2, -1.2). Because the upper 95% CI limit was less than the pre-specified noninferiority margin of 15%, LEV was considered noninferior to OXC. Twenty-four-week and 48-week seizure freedom rates were 53.8% and 34.7% for LEV vs. 58.5% and 40.9% for OXC. Both LEV and OXC were well tolerated, with 8.7% and 8.6% of patients reporting serious treatment-emergent adverse events, respectively. By comparing LEV with OXC, another newer AED, LEV can be considered a useful option as initial monotherapy for patients with newly diagnosed focal epilepsy. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.subject | CONTROLLED-RELEASE CARBAMAZEPINE | - |
dc.subject | PREVIOUSLY UNTREATED EPILEPSY | - |
dc.subject | REFRACTORY PARTIAL SEIZURES | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | PARALLEL-GROUP | - |
dc.subject | MULTICENTER | - |
dc.subject | EFFICACY | - |
dc.subject | SAFETY | - |
dc.title | Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Ji Hyun | - |
dc.identifier.doi | 10.1111/epi.13707 | - |
dc.identifier.scopusid | 2-s2.0-85017294964 | - |
dc.identifier.wosid | 000398861000005 | - |
dc.identifier.bibliographicCitation | EPILEPSIA, v.58, no.4, pp.E70 - E74 | - |
dc.relation.isPartOf | EPILEPSIA | - |
dc.citation.title | EPILEPSIA | - |
dc.citation.volume | 58 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | E70 | - |
dc.citation.endPage | E74 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Neurosciences & Neurology | - |
dc.relation.journalWebOfScienceCategory | Clinical Neurology | - |
dc.subject.keywordPlus | CONTROLLED-RELEASE CARBAMAZEPINE | - |
dc.subject.keywordPlus | PREVIOUSLY UNTREATED EPILEPSY | - |
dc.subject.keywordPlus | REFRACTORY PARTIAL SEIZURES | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordAuthor | Seizures | - |
dc.subject.keywordAuthor | Antiepileptic drugs | - |
dc.subject.keywordAuthor | Effectiveness | - |
dc.subject.keywordAuthor | Safety | - |
dc.subject.keywordAuthor | Tolerability | - |
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