title: Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial.
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 (16-80 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.
authors.affiliation: Department of Neurology, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Ji Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Neurology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
authors.forename: Sang Kun
authors.initials: SK
authors.lastname: Lee
authors.affiliation: UCB Pharma, Monheim, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Loesch
authors.affiliation: UCB Pharma, Seoul, South Korea.
authors.forename: Kyungsun
authors.initials: K
authors.lastname: Namgoong
authors.affiliation: Department of Neurology, Epilepsy and Sleep Center, Ewha Womans University School of Medicine and Ewha Medical Research Institute, Seoul, Korea.
authors.forename: Hyang Woon
authors.initials: HW
authors.lastname: Lee
authors.affiliation: Department of Neurology, Neuroscience Center, Samsung Medical Center, Sungkyunkwan University School of Medicine and Samsung Biomedical Research Institute (SBRI), Seoul, Korea.|Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Seung Bong
authors.initials: SB
authors.lastname: Hong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D002220:Carbamazepine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D000078330:Oxcarbazepine; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D056910:Republic of Korea; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000077287:Levetiracetam; D000078330:Oxcarbazepine; D010889:Piracetam
keywords: Antiepileptic drugs; Effectiveness; Safety; Seizures; Tolerability