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CNS Drugs
Published in: CNS Drugs 10/2013

Open Access 01-10-2013 | Systematic Review

Systematic Review and Meta-Analysis of the Efficacy and Safety of Perampanel in the Treatment of Partial-Onset Epilepsy

Authors: Warrington W. Q. Hsu, C. W. Sing, Ying He, Alan J. Worsley, Ian C. K. Wong, Esther W. Chan

Published in: CNS Drugs | Issue 10/2013

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Abstract

Introduction

Perampanel is a first-in-class antiepileptic drug approved for adjunctive treatment of partial-onset seizure in patients aged 12 years or older. Published randomised controlled trials (RCTs) had small sample sizes, and meta-analyses have included too few studies to draw conclusive results for the assessment of tolerability, efficacy and safety of perampanel. There is a need to conduct a meta-analysis with a larger dataset and an appropriate study design.

Objective

The aim of this study was to systematically review the efficacy and safety of perampanel in the treatment of partial-onset epilepsy.

Methods

Electronic and clinical trials databases were searched for RCTs of perampanel published up to March 2013. Outcomes of interest were 50 % responder rates, seizure freedom, treatment-emergent adverse events (TEAEs) and incidence of withdrawal. Meta-analysis was performed to investigate the outcomes of interest.

Results

Five RCTs with a total of 1,678 subjects were included. The 50 % responder rates were significantly greater in patients receiving 4, 8 and 12 mg perampanel versus placebo, with risk ratios of 1.54 (95 % CI 1.11–2.13), 1.80 (95 % CI 1.38–2.35) and 1.72 (95 % CI 1.17–2.52), respectively. There was no statistical evidence of a difference in seizure freedom between 8 or 12 mg perampanel and placebo. Of the five commonly reported TEAEs included, both dizziness and somnolence were statistically associated with 8 mg perampanel, whilst dizziness was statistically associated with 12 mg perampanel. Incidences of withdrawal due to adverse events were significantly higher in the 8 mg and 12 mg perampanel groups versus placebo.

Conclusion

The use of perampanel resulted in a statistically significant reduction of seizure frequency with respect to the 50 % responder rate in patients with partial-onset epilepsy. Perampanel is well tolerated at 4 mg and reasonably tolerated at 8 and 12 mg. Further clinical and pharmacovigilance studies are required to investigate the long-term efficacy and safety of perampanel in the management of other types of epilepsy.
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Metadata
Title
Systematic Review and Meta-Analysis of the Efficacy and Safety of Perampanel in the Treatment of Partial-Onset Epilepsy
Authors
Warrington W. Q. Hsu
C. W. Sing
Ying He
Alan J. Worsley
Ian C. K. Wong
Esther W. Chan
Publication date
01-10-2013
Publisher
Springer International Publishing
Published in
CNS Drugs / Issue 10/2013
Print ISSN: 1172-7047
Electronic ISSN: 1179-1934
DOI
https://doi.org/10.1007/s40263-013-0091-9

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