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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51840
Title: Efficacy, safety, and tolerability of perampanel in Asian and non-Asian patients with epilepsy
Authors: Jing Jane Tsai
Akio Ikeda
Seung Bong Hong
Surachai Likasitwattanakul
Amitabh Dash
Graduate School of Medicine
National Cheng Kung University Hospital
SungKyunKwan University, School of Medicine
Mahidol University
Eisai Singapore Pte. Ltd.
Keywords: Medicine
Issue Date: 1-Mar-2019
Citation: Epilepsia. Vol.60, No.S1 (2019), 37-46
Abstract: Wiley Periodicals, Inc. © 2019 International League Against Epilepsy People of different ethnic or racial backgrounds may experience variations in pharmacokinetic and pharmacodynamic responses to drug therapies. Our post hoc analysis evaluated the efficacy, safety, and tolerability of perampanel in Asian and non-Asian populations with refractory focal seizures with or without focal to bilateral tonic-clonic (FBTC) seizures. This analysis pooled data from 4 randomized, placebo-controlled, phase-3 studies involving patients aged ≥12 years who have focal seizures with or without FBTC seizures. Patients were receiving 2, 4, 8, or 12 mg perampanel (or placebo) by the end of a 6-week titration period and for a further 13 weeks during the maintenance phase. Efficacy endpoints included median percent change in seizure frequency per 28 days, and 50% and seizure-freedom responder rates relative to baseline. The median percent change in seizure frequency per 28 days from baseline was significantly greater than placebo for perampanel 8 and 12 mg (−31.1% and −38.1% change, respectively; each P < 0.0001) in the Asian population, and for perampanel 4, 8, and 12 mg (−21.1% [P = 0.0001], −26.3% [P < 0.0001], and −27.7% [P = 0.0001] change, respectively) in the non-Asian population. The 50% responder rate relative to baseline was significantly greater than placebo for perampanel 8 and 12 mg (40.1% and 43.8%, respectively; each P < 0.0001) in the Asian population, and for perampanel 4, 8, and 12 mg (29.4% [P = 0.0002], 32.8% [P < 0.0001] and 34.5% [P = 0.0001]), respectively, in the non-Asian population. Seizure-freedom rate among all patients was 4.9%-11.7% for perampanel 2, 4, 8, and 12 mg. The most frequently reported treatment-emergent adverse events (TEAEs) across both populations were dizziness, somnolence, irritability, headache, and fatigue. The most common psychiatric TEAEs were aggression and irritability. Perampanel demonstrated a favorable and similar risk-benefit profile in both Asian and non-Asian populations with refractory focal seizures.
URI: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51840
metadata.dc.identifier.url: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85062870561&origin=inward
ISSN: 15281167
00139580
Appears in Collections:Scopus 2019

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