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

the Korean N01367 Study Group

Research output: Contribution to journalArticle

1 Citation (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 (16–80 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.

Original languageEnglish
Pages (from-to)e70-e74
JournalEpilepsia
Volume58
Issue number4
DOIs
Publication statusPublished - 2017 Apr 1

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etiracetam
Partial Epilepsy
Anticonvulsants
Seizures
Confidence Intervals
Safety
oxcarbazepine
Treatment Failure

Keywords

  • Antiepileptic drugs
  • Effectiveness
  • Safety
  • Seizures
  • Tolerability

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy : A long-term, randomized, open-label trial. / the Korean N01367 Study Group.

In: Epilepsia, Vol. 58, No. 4, 01.04.2017, p. e70-e74.

Research output: Contribution to journalArticle

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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.",
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