PMID- 26362377
OWN - NLM
STAT- MEDLINE
DCOM- 20160609
LR  - 20220330
IS  - 1532-2688 (Electronic)
IS  - 1059-1311 (Linking)
VI  - 31
DP  - 2015 Sep
TI  - The adverse event profile of levetiracetam: A meta-analysis on children and 
      adults.
PG  - 49-55
LID - S1059-1311(15)00167-3 [pii]
LID - 10.1016/j.seizure.2015.07.004 [doi]
AB  - PURPOSE: To analyze the adverse events (AEs) significantly associated with 
      levetiracetam (LEV) therapy through a meta-analysis of all available 
      double-blind, randomized placebo-controlled trials (RCTs), performed in any age, 
      gender, ethnic background and disease. General tolerability and study withdrawals 
      due to AEs associated with LEV treatment were also investigated. In addition, a 
      dose-effect responses relationship for all variables was assessed. METHODS: RCTs 
      were identified searching Medline (PubMed), Embase and Cochrane CENTRAL for the 
      words "Levetiracetam" and "randomized controlled trial", with different search 
      strategies, setting the limits "humans" and "English". Very common and common AEs 
      according to the summary of product characteristics were investigated. RevMan 
      version 5.2 was used for the statistical analyses. Risk difference with 95% 
      confidence intervals was used to investigate the association of any AEs and 
      withdrawal with LEV. RESULTS: Twenty-six studies with 2832 patients were included 
      in the RCTs analysis. Nasopharyngitis, somnolence, dizziness, 
      nervousness/irritability and asthenia/fatigue were statistically significant 
      associated with LEV. In addition, LEV was significantly associated with an 
      increased risk of AEs-related withdrawals. No dose-response relationship was 
      found for any of the assessed variables. CONCLUSIONS: This first large 
      meta-analysis suggests that participants were more likely to discontinue LEV than 
      placebo. The AE profile confirmed that LEV is associated with few unfavorable 
      sedative, vestibulocerebellar and behavioral effects, such as nervousness and 
      irritability. However, there does not seem to be a clear dose-response 
      relationship.
CI  - Copyright (c) 2015 British Epilepsy Association. Published by Elsevier Ltd. All 
      rights reserved.
FAU - Verrotti, Alberto
AU  - Verrotti A
AD  - Department of Pediatrics, University of Perugia, Perugia, Italy. Electronic 
      address: averrott@unich.it.
FAU - Prezioso, Giovanni
AU  - Prezioso G
AD  - Department of Pediatrics, University of Chieti, Chieti, Italy.
FAU - Di Sabatino, Fabiana
AU  - Di Sabatino F
AD  - Department of Pediatrics, University of Chieti, Chieti, Italy.
FAU - Franco, Valentina
AU  - Franco V
AD  - Clinical and Experimental Pharmacology Unit, Department of Internal Medicine and 
      Therapeutics, University of Pavia, Pavia, Italy; C. Mondino National Neurological 
      Institute, Pavia, Italy.
FAU - Chiarelli, Francesco
AU  - Chiarelli F
AD  - Department of Pediatrics, University of Chieti, Chieti, Italy.
FAU - Zaccara, Gaetano
AU  - Zaccara G
AD  - Unit of Neurology, Department of Medicine, Florence Health Authority, Firenze, 
      Italy.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20150714
PL  - England
TA  - Seizure
JT  - Seizure
JID - 9306979
RN  - 0 (Anticonvulsants)
RN  - 44YRR34555 (Levetiracetam)
RN  - ZH516LNZ10 (Piracetam)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticonvulsants/*adverse effects/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Dose-Response Relationship, Drug
MH  - Humans
MH  - Levetiracetam
MH  - Middle Aged
MH  - Piracetam/adverse effects/*analogs & derivatives/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse events
OT  - Antiepileptic drug
OT  - Discontinuation
OT  - Levetiracetam
OT  - Meta-analysis
OT  - Tolerability
EDAT- 2015/09/13 06:00
MHDA- 2016/06/10 06:00
CRDT- 2015/09/13 06:00
PHST- 2015/03/02 00:00 [received]
PHST- 2015/07/05 00:00 [revised]
PHST- 2015/07/07 00:00 [accepted]
PHST- 2015/09/13 06:00 [entrez]
PHST- 2015/09/13 06:00 [pubmed]
PHST- 2016/06/10 06:00 [medline]
AID - S1059-1311(15)00167-3 [pii]
AID - 10.1016/j.seizure.2015.07.004 [doi]
PST - ppublish
SO  - Seizure. 2015 Sep;31:49-55. doi: 10.1016/j.seizure.2015.07.004. Epub 2015 Jul 14.