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Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial

Title
Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial
Authors
Kim, Ji HyunLee, Sang KunLoesch, ChristianNamgoong, KyungsunLee, Hyang WoonHong, Seung BongKorean N01367 Study Grp
Ewha Authors
이향운
SCOPUS Author ID
이향운scopus
Issue Date
2017
Journal Title
EPILEPSIA
ISSN
0013-9580JCR Link1528-1167JCR Link
Citation
vol. 58, no. 4, pp. E70 - E74
Keywords
SeizuresAntiepileptic drugsEffectivenessSafetyTolerability
Publisher
WILEY
Indexed
SCI; SCIE; SCOPUS WOS scopus
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.
DOI
10.1111/epi.13707
Appears in Collections:
의과대학 > 의학과 > Journal papers
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