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• W2105535280 abstract "Background and purpose To identify adverse events ( AE s) significantly associated with perampanel treatment in double‐blind clinical studies ( RCT s). Serious AE s, study withdrawals due to AE s and dose–effect responses of individual AE s were also investigated. Methods All placebo controlled, double‐blind RCT s investigating therapeutic effects of oral perampanel were searched. AE s were assessed for their association with perampanel after exclusion of synonyms, rare AE s and non‐assessable AE s. Risk difference ( RD ) was used to evaluate the association of any AE (99% confidence intervals) and withdrawals or serious AEs (95% confidence intervals) with perampanel. Results Nine RCT s (five in pharmacoresistant epilepsy and four in P arkinson's disease) were included in our study. Almost 4000 patients had been recruited, 2627 of whom were randomized to perampanel and treated with drug doses of 0.5 mg/day ( n = 68), 1 mg/day ( n = 65), 2 mg/day ( n = 753), 4 mg/day ( n = 1017), 8 mg/day ( n = 431) or 12 mg/day ( n = 293). Serious AE s were not significantly associated with perampanel treatment. The experimental drug was significantly associated with an increased risk of AE ‐related study withdrawals at 4 mg/day [ RD (95% confidence interval) 0.03 (0.00, 0.06)] and 12 mg/day [ RD (95% confidence interval) 0.13 (0.07, 0.18)]. Of 15 identified AE s, five (dizziness, ataxia, somnolence, irritability and weight increase) were found to be significantly associated with perampanel and one (seizure worsening) was significantly associated with placebo. Conclusions Vestibulocerebellar AE s (dizziness, ataxia), sedative effects (somnolence), irritability and weight increase were significantly associated with perampanel treatment." @default.
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• W2105535280 date "2013-04-23" @default.
• W2105535280 modified "2023-10-03" @default.
• W2105535280 title "The adverse event profile of perampanel: meta-analysis of randomized controlled trials" @default.
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• W2105535280 doi "https://doi.org/10.1111/ene.12170" @default.
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