J Korean Epilepsy Soc.  2007 Jun;11(1):25-32.

Efficacy and Safety of Levetiracetam as Adjunctive Treatment in a Multicenter Open-Label Single-Arm Trial in Korean Patients with Refractory Partial Epilepsy: Over 1-Year Follow-Up

Affiliations
  • 1Department of Neurology, Severance Hospital, Seoul, Korea. kheo@yuhs.ac.kr
  • 2Department of Neurology, Keimyung University Dongsan Medical Center, Daegu, Korea.
  • 3Department of Neurology, Ajou University Medical Center, Suwon, Korea.
  • 4Department of Neurology, Chungnam National University Hospital, Daejeon, Korea.
  • 5Department of Neurology, Asan Medical Center, Seoul, Korea.
  • 6Department of Neurology, Gachon Medical School Gil Medical Center, Incheon, Korea.
  • 7Department of Neurology, Kangdong Sacred Heart Hospital, Seoul, Korea.
  • 8Department of Neurology, Seoul National University Hospital, Seoul, Korea.
  • 9Department of Neurology, Inje University Sanggye Paik Hospital, Seoul, Korea.

Abstract

PURPOSE: This prospective, open-label study evaluated the efficacy and safety of adjunctive levetiracetam (LEV) in Korean adults with uncontrolled partial epilepsy.
METHODS
A total of 100 patients whose partial seizures were inadequately controlled on their current antiepileptic drugs were enrolled and received LEV (1000-3000 mg/day). Seizure count and adverse events (AEs) were recorded by patients. Global evaluation scale (GES) and quality of life (QOLIE-31) were also evaluated. Additionally effectiveness over 1-year follow-up was investigated.
RESULTS
Ninety-two patients completed the short-term 16-week trial. The median percent reduction in weekly seizure frequency over the treatment period was 43.2%. The > or =50% and > or =75% responder rates were 45.4% and 36.1%, respectively. Seizure freedom was observed in 17 patients throughout the initial 16-week treatment period. On investigator's GES, 81 patients were considered improved, with 41 patients showing marked improvement. Most QOLIE-31 scales improved significantly. At the end of the trial, 79 chose to continue follow-up treatment with LEV. At the follow-up visit (ranging 60 to 81 weeks), 64 patients were still taking LEV; during the last 16 weeks, 65.6% of patients had > or =50% reduction, 50.0% had > or =75% reduction, and 35.9% had a 100% reduction. Seven patients showed continuous seizure freedom from the initiation of LEV treatment. During the entire treatment period, LEV was withdrawn in 36 patients; due to lack of efficacy in 22, AEs in six, both in three, other reasons in five.
CONCLUSION
Adjunctive LEV therapy in patients with refractory partial epilepsy was effective and well-tolerated, as evidenced by the high seizure freedom and retention rates in both the short-term trial and the long-term follow-up.

Keyword

Antiepileptic drugs; Levetiracetam; Epilepsy; Partial seizures; Open-label study; Add-on therapy; Long-term therapy
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