期刊
SEIZURE-EUROPEAN JOURNAL OF EPILEPSY
卷 102, 期 -, 页码 54-60出版社
W B SAUNDERS CO LTD
DOI: 10.1016/j.seizure.2022.09.020
关键词
Perampanel; Epilepsy; Safety; Efficacy; Systematic review; Meta-analysis and drug safety; Antiepileptic drugs; Antiseizure medications; e2007; Fycompa; Adverse events
This systematic review examines the effectiveness and safety of Perampanel in treating epilepsy. The results show a significant reduction in seizures and a potential increase in discontinuations due to treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs are non-threatening, but there is a possibility of rare but serious adverse psychological outcomes.
Background: Perampanel a third-generation antiseizure medication, belongs to a new promising class of drugs called AMPA receptor antagonists, approved to treat focal-onset seizures with or without focal to bilateral tonic clonic seizures and primary generalized tonic-clonic seizures.Methods: This review included RCTs on patients with epilepsy exposed to perampanel compared with placebo, or one or more pre-existing antiseizure medications. Four databases and two clinical trial registries were searched from inception to July 2021. Included outcomes were 50% responder rate, seizure-free rate, discontinuation due to treatment-emergent adverse events (TEAE)s, having any TEAEs, and most reported TEAEs. Cochrane risk of bias tool was used to assess the internal validity of the included RCTs. Results: From 2211 retrieved citations, eight RCTs were included in the meta-analysis. Fifty-percent responder and seizure freedom rates were significantly higher in patients receiving perampanel when compared to placebo (RR 1.57, 95 % CI 1.35 to 1.82, I2 15% and RR 2.79, 95% CI 1.58 to 4.93, I2 7%, respectively). The 50% responder rates for 8mg and 12 mg, when compared to placebo, were similar. The most-reported TEAEs were dizziness and somnolence with <1% reporting serious psychological outcomes. Conclusion: This systematic review reports significant reduction in seizures and a potential dose-based increase in discontinuations due to TEAE. The most-reported TEAEs were non-threatening, with the possibility of rare but serious adverse psychological outcomes. Further independent RCTs studying the most efficient dose for efficacy and safety are needed.
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