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Efficacy in focal epilepsy   

Efficacy in adults ≥ 16 years

Keppra as a monotherapy demonstrated comparable rates of seizure freedom to carbamazepine CR in adult patients with focal epilepsy1

Seizure freedom rates in adults (≥16 years) on levetiracetam or carbamazepine CR1

Randomised, double-blind, parallel-group, comparator-controlled monotherapy trial.
Primary objective was to demonstrate that monotherapy with LEV (1000 to 3000 mg/day) (n=288) was non-inferior to monotherapy with CBZ CR (400 to 1200 mg/day) (n=291) in adults (≥16 years) with newly diagnosed epilepsy.1

The same results were first published in Brodie MJ, et al. Neurology 2007;68:402–408. The graph has been independently created by GSK from the original data.

Safety information: A similar proportion of patients in the Keppra (79.6%) and CBZ CR groups (80.8%) experienced at least one adverse event during the treatment period.

If responses are inadequate at lower doses, a higher daily dose of Keppra (2000 mg/3000 mg) may lead to a better response2

Patients (%) experiencing reductions of ≥50% or 100% in seizure frequency vs baseline with various doses of LEV and placebo2

Analysis using pooled data from three trials including adults with refractory focal epilepsy. Two were trials in which doses of 1000–3000 mg/day of levetiracetam were administered as adjunctive therapy. The third consisted of the two parts of a crossover study in which levetiracetam (1000 or 2000 mg/day) or placebo was added to ongoing therapy. A fourth trial was added for the safety evaluation. It included data from adults receiving placebo or 2000 mg/day of levetiracetam as adjunctive therapy for refractory focal seizures.2

The graph is reproduced with the permission of John Wiley and Sons. It was first published in Meencke HJ, Buyle S. Eur J Neurol 2006;13:942–946.

Safety information: There was no evidence of a dose-response relationship with regard to adverse events (including asthenia, dizziness, somnolence) in this study. Some patients may begin to experience a greater intolerance to Keppra if the dose is increased.2

Efficacy in children ≥4 years

Keppra reduced seizure frequency in children with treatment-resistant focal epilepsy vs placebo, used adjunctively3

Median percentage reduction from baseline in weekly focal seizure frequency during treatment (14 weeks) in children aged 4–16 years3

 

Multicentre, randomised, placebo-controlled trial that evaluated the efficacy and tolerability of LEV as adjunctive therapy in children aged 4–16 years (n=198) with treatment-resistant focal seizures. It consisted of an 8-week baseline period followed by a 14-week double-blind treatment period. During the treatment period, patients received either placebo or LEV add-on therapy and were up-titrated to a target dose of 60 mg/kg/day.3

 

The same results were first published in Glauser TA, et al. Neurology 2006;66:1654–1660. The graph has been independently created by GSK from the original data.

Safety information: Available data in children do not suggest an impact on growth and puberty. However, long-term effects in children on learning, intelligence, growth, endocrine function, puberty and childbearing potential remain unknown.4

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Abbreviations

AED: anti-epileptic drug; CBZ: carbamazepine; CI: confidence interval; CR: controlled release; LEV: levetiracetam; SD: study design.

References

  1. Brodie MJ, et al. Neurology 2007;68:402–408.
  2. Meencke HJ, Buyle S. Eur J Neurol 2006;13:942–946.
  3. Glauser TA, et al. Neurology 2006;66:1654–1660.
  4. Keppra Prescribing Information, Version 09, September 2018.

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PM-NG-LVT-WCNT-200004 Date of preparation: November 2020.