Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long‐term, randomized, open‐label trial. (April 2017)

• Record Type: Journal Article
• Authors: Kim, Ji Hyun; Lee, Sang Kun; Loesch, Christian; Namgoong, Kyungsun; Lee, Hyang Woon; Hong, Seung Bong
• Other Names: Shin Chul investigator.; Kim Sung‐eun investigator.; Kim JaeMoon investigator.; Kim Kyu investigator.; Kim Ki investigator.; Han Jeong investigator.; Son Jeyong investigator.; Kim Woojun investigator.; Shon Min investigator.; Kim JeongYeon investigator.; Park Sungho investigator.; Ji Ki‐Hwan investigator.; Nam Hyunwoo investigator.; Jang Hyun investigator.; Lee Mi investigator.; Kim Wook investigator.; Jung Ki‐Young investigator.; Koo Yong‐Seo investigator.; Bae Eun‐kee investigator.; Kim Sunghun investigator.
• Is Part Of: Epilepsia. Volume 58:issue 4(2017)
• Page Start: e70
• Page End: e74
• Publication Date: 2017-04
• Subjects: Seizures -- Antiepileptic drugs -- Effectiveness -- Safety -- Tolerability; Epilepsy -- Periodicals; 616.853
• DOI: 10.1111/epi.13707
• Languages: English
• ISSNs: 0013-9580

Abstract

Summary: 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 (16–80 years), with ≥2 unprovoked focal seizures in the year preceding the trial, who had not taken any antiepileptic drugs (AEDs) in the last 6 months, 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.