PMID- 34785411
OWN - NLM
STAT- MEDLINE
DCOM- 20211210
LR  - 20220512
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 125
DP  - 2021 Dec
TI  - Long-term efficacy and safety of perampanel as a first add-on therapy in patients 
      with focal epilepsy: Three-year extension study.
PG  - 108407
LID - S1525-5050(21)00668-5 [pii]
LID - 10.1016/j.yebeh.2021.108407 [doi]
AB  - PURPOSE: We investigated the long-term efficacy and safety of perampanel as a 
      first add-on therapy in patients with focal epilepsy. METHODS: This retrospective 
      study represented the 3-year extension phase of a multicenter, open-label, phase 
      4, prospective study of perampanel as a first add-on therapy in patients with 
      focal epilepsy. Seizure and safety outcomes were assessed annually from the start 
      of the extension study, and the retention rate was calculated from the start of 
      perampanel exposure in the original study. RESULTS: The 50% responder and seizure 
      freedom rates were 84.8% and 58.7%, respectively, during the third year and 71.7% 
      and 32.6%, respectively, during the entire 3-year period of the extension study. 
      The 1-, 2-, and 3-year retention rates were 62.5%, 53.1%, and 52.1%, 
      respectively. Efficacies were higher in patients that were aged >55 years, male, 
      and receiving </=4 mg of perampanel. Perampanel was generally well tolerated; 47.3% 
      of patients experienced at least one adverse event during the 3 years of 
      extension (46 adverse events (AEs) in 35 patients). The most common AEs were 
      dizziness (33.8%), somnolence (5.4%), anger (4.1%), and irritability (4.1%). AEs 
      were resolved with perampanel dose reduction or discontinuation in 10 (13.5%) and 
      12 (16.2%) patients, respectively. CONCLUSION: Long-term treatment with 
      perampanel as a first add-on therapy did not raise new safety signals in patients 
      with focal epilepsy. Especially at low perampanel doses (</=4 mg/day), sustained 
      improvement in seizure control was achieved, which could potentially avoid 
      adverse drug reactions.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Im, Kayeong
AU  - Im K
AD  - Department of Neurology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Republic of Korea.
FAU - Lee, Sang-Ahm
AU  - Lee SA
AD  - Department of Neurology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Republic of Korea. Electronic address: salee@amc.seoul.kr.
FAU - Kim, Ji Hyun
AU  - Kim JH
AD  - Department of Neurology, Korea University Guro Hospital, Korea University College 
      of Medicine, Seoul, Republic of Korea.
FAU - Kim, Dong Wook
AU  - Kim DW
AD  - Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of 
      Korea.
FAU - Lee, Sang Kun
AU  - Lee SK
AD  - Department of Neurology, Seoul National University Hospital, Seoul National 
      University College of Medicine, Seoul, Republic of Korea.
FAU - Seo, Dae Won
AU  - Seo DW
AD  - Department of Neurology, Samsung Medical Center, Sungkyunkwan University School 
      of Medicine, Seoul, Republic of Korea.
FAU - Lee, Ji Woong
AU  - Lee JW
AD  - Eisai Korea Inc., Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20211113
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 0 (Nitriles)
RN  - 0 (Pyridones)
RN  - H821664NPK (perampanel)
SB  - IM
CIN - Epilepsy Behav. 2022 Apr;129:108608. PMID: 35181218
CIN - Epilepsy Behav. 2022 Apr;129:108654. PMID: 35305920
MH  - *Anticonvulsants/therapeutic use
MH  - Drug Therapy, Combination
MH  - *Epilepsies, Partial/drug therapy
MH  - Humans
MH  - Male
MH  - Nitriles
MH  - Prospective Studies
MH  - Pyridones/adverse effects
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Efficacy
OT  - Epilepsy
OT  - Perampanel
OT  - Responder rate
OT  - Retention rate
OT  - Safety
COIS- Conflicts of interest Ji Woong Lee is an employee of Eisai Korea Inc. All other 
      authors declare no conflicts of interest in relation to this study.
EDAT- 2021/11/18 06:00
MHDA- 2021/12/15 06:00
CRDT- 2021/11/17 05:55
PHST- 2021/09/22 00:00 [received]
PHST- 2021/10/20 00:00 [revised]
PHST- 2021/10/23 00:00 [accepted]
PHST- 2021/11/18 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/11/17 05:55 [entrez]
AID - S1525-5050(21)00668-5 [pii]
AID - 10.1016/j.yebeh.2021.108407 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2021 Dec;125:108407. doi: 10.1016/j.yebeh.2021.108407. Epub 2021 
      Nov 13.