Efficacy and safety of perampanel in generalized and focal to bilateral tonic-clonic seizures: A comparative study of Asian and non-Asian populations

Takuji Nishida, Sang Kun Lee*, Tony Wu, Somsak Tiamkao, Amitabh Dash

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

13 Scopus citations

Abstract

Perampanel is an approved adjunctive treatment for focal seizures with or without focal to bilateral tonic-clonic (FBTC) seizures and generalized tonic-clonic (GTC) seizures. We compared efficacy and safety of perampanel vs placebo in Asian and non-Asian populations in a post hoc analysis of pooled data from 5 randomized phase 3 studies. Patients (≥12 years old) with focal + FBTC seizures received perampanel 2, 4, 8, or 12 mg or placebo; patients with GTC seizures received perampanel 8 mg or placebo (titration: 4-6 weeks; maintenance: 13 weeks). Efficacy endpoints included median percentage change in FBTC or GTC seizure frequency per 28 days and 50% responder rate relative to baseline. Median percentage change in FBTC seizure frequency was significantly greater for perampanel 8 and 12 mg than placebo in the Asian population (median difference from placebo: −30.32%, P = 0.0017; −30.06%, P = 0.0008, respectively) and perampanel 4, 8, and 12 mg in the non-Asian population (−35.07%, P = 0.0001; −37.78%, P < 0.0001; −34.53%, P < 0.0001, respectively). In both populations, median percentage change in GTC seizure frequency was significantly greater for perampanel 8 mg than placebo (median difference from placebo: Asian, −37.37%, P = 0.0139; non-Asian, −27.04%, P = 0.0006). The 50% responder rates were significantly greater than placebo for perampanel 8 and 12 mg for FBTC seizures (Asian: 58.0%, P = 0.0017 and 58.6%, P = 0.0013, respectively; non-Asian: 59.3%, P < 0.0001 and 54.3%, P = 0.0050, respectively) and perampanel 8 mg for GTC seizures (Asian: 57.6%, P = 0.0209; non-Asian: 68.8%, P = 0.0329). Pooled FBTC/GTC seizure data showed generally similar patterns of response to perampanel in both populations. The most frequent treatment-related adverse events were fatigue, irritability, dizziness, somnolence, and headache. Perampanel was effective, well tolerated, and can be considered a therapeutic option for FBTC/GTC seizures in Asian populations.

Original languageEnglish
Pages (from-to)47-59
Number of pages13
JournalEpilepsia
Volume60
Issue numberS1
DOIs
StatePublished - 03 2019
Externally publishedYes

Bibliographical note

Publisher Copyright:
Wiley Periodicals, Inc. © 2019 International League Against Epilepsy

Keywords

  • Asian
  • antiepileptic drugs
  • focal seizures
  • focal to bilateral tonic-clonic seizures
  • generalized tonic-clonic seizures

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