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Article: Systematic review and meta-analysis of the efficacy and safety of perampanel in the treatment of partial-onset epilepsy

TitleSystematic review and meta-analysis of the efficacy and safety of perampanel in the treatment of partial-onset epilepsy
Authors
Issue Date2013
Citation
CNS Drugs, 2013, v. 27, n. 10, p. 817-827 How to Cite?
AbstractIntroduction: 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. © 2013 The Author(s).
Persistent Identifierhttp://hdl.handle.net/10722/311958
ISSN
2023 Impact Factor: 7.4
2023 SCImago Journal Rankings: 1.616
ISI Accession Number ID
Errata

 

DC FieldValueLanguage
dc.contributor.authorHsu, Warrington W.Q.-
dc.contributor.authorSing, C. W.-
dc.contributor.authorHe, Ying-
dc.contributor.authorWorsley, Alan J.-
dc.contributor.authorWong, Ian C.K.-
dc.contributor.authorChan, Esther W.-
dc.date.accessioned2022-04-06T04:31:51Z-
dc.date.available2022-04-06T04:31:51Z-
dc.date.issued2013-
dc.identifier.citationCNS Drugs, 2013, v. 27, n. 10, p. 817-827-
dc.identifier.issn1172-7047-
dc.identifier.urihttp://hdl.handle.net/10722/311958-
dc.description.abstractIntroduction: 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. © 2013 The Author(s).-
dc.languageeng-
dc.relation.ispartofCNS Drugs-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.titleSystematic review and meta-analysis of the efficacy and safety of perampanel in the treatment of partial-onset epilepsy-
dc.typeArticle-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1007/s40263-013-0091-9-
dc.identifier.pmid23918722-
dc.identifier.scopuseid_2-s2.0-84885441198-
dc.identifier.hkuros226195-
dc.identifier.hkuros218703-
dc.identifier.volume27-
dc.identifier.issue10-
dc.identifier.spage817-
dc.identifier.epage827-
dc.identifier.eissn1179-1934-
dc.identifier.isiWOS:000324879300004-
dc.relation.erratumdoi:10.1007/s40263-013-0125-3-
dc.relation.erratumeid:eid_2-s2.0-84890463187-

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