PMID- 23607817
OWN - NLM
STAT- MEDLINE
DCOM- 20140207
LR  - 20211203
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 20
IP  - 8
DP  - 2013 Aug
TI  - The adverse event profile of perampanel: meta-analysis of randomized controlled 
      trials.
PG  - 1204-11
LID - 10.1111/ene.12170 [doi]
AB  - BACKGROUND AND PURPOSE: To identify adverse events (AEs) significantly associated 
      with perampanel treatment in double-blind clinical studies (RCTs). Serious AEs, 
      study withdrawals due to AEs and dose-effect responses of individual AEs were 
      also investigated. METHODS: All placebo controlled, double-blind RCTs 
      investigating therapeutic effects of oral perampanel were searched. AEs were 
      assessed for their association with perampanel after exclusion of synonyms, rare 
      AEs and non-assessable AEs. 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 RCTs (five in 
      pharmacoresistant epilepsy and four in Parkinson'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 AEs 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 AEs, 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 AEs (dizziness, ataxia), sedative effects (somnolence), 
      irritability and weight increase were significantly associated with perampanel 
      treatment.
CI  - (c) 2013 The Author(s) European Journal of Neurology (c) 2013 EFNS.
FAU - Zaccara, G
AU  - Zaccara G
AD  - Unit of Neurology, Department of Medicine, Florence Health Authority, Firenze, 
      Italy. gaetano.zaccara@asf.toscana.it
FAU - Giovannelli, F
AU  - Giovannelli F
FAU - Cincotta, M
AU  - Cincotta M
FAU - Verrotti, A
AU  - Verrotti A
FAU - Grillo, E
AU  - Grillo E
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20130423
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Anticonvulsants)
RN  - 0 (Nitriles)
RN  - 0 (Pyridones)
RN  - H821664NPK (perampanel)
SB  - IM
MH  - Anticonvulsants/administration & dosage/*adverse effects/*therapeutic use
MH  - Confidence Intervals
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Resistance
MH  - Epilepsies, Partial/drug therapy
MH  - Epilepsy/drug therapy
MH  - Humans
MH  - Nitriles
MH  - Parkinson Disease/drug therapy
MH  - Pyridones/administration & dosage/*adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Seizures/drug therapy
OTO - NOTNLM
OT  - adverse effects
OT  - antiepileptic drugs
OT  - epilepsy
OT  - meta-analysis
OT  - perampanel
OT  - side effects
EDAT- 2013/04/24 06:00
MHDA- 2014/02/08 06:00
CRDT- 2013/04/24 06:00
PHST- 2013/01/20 00:00 [received]
PHST- 2013/03/11 00:00 [accepted]
PHST- 2013/04/24 06:00 [entrez]
PHST- 2013/04/24 06:00 [pubmed]
PHST- 2014/02/08 06:00 [medline]
AID - 10.1111/ene.12170 [doi]
PST - ppublish
SO  - Eur J Neurol. 2013 Aug;20(8):1204-11. doi: 10.1111/ene.12170. Epub 2013 Apr 23.