PMID- 23763367
OWN - NLM
STAT- MEDLINE
DCOM- 20141104
LR  - 20181202
IS  - 1600-0404 (Electronic)
IS  - 0001-6314 (Linking)
VI  - 128
IP  - 5
DP  - 2013 Nov
TI  - The adverse event profile of zonisamide: a meta-analysis.
PG  - 297-304
LID - 10.1111/ane.12147 [doi]
AB  - The first aim of our study was to analyze the adverse events statistically 
      significantly associated with zonisamide, through a systematic review and 
      meta-analysis of available randomized placebo-controlled trials (RCTs). The 
      second aim was to compare these results with those obtained from an analysis of 
      non-RCTs and observational studies. Randomized controlled trials were identified 
      using Medline (PubMed), EMBASE (Ovid), and Cochrane CENTRAL, from 1990 to 
      September 2012. RevMan version 5.1 and OpenMeta[Analyst] were used for analyses 
      of RCT and non-RCTs, respectively. Six eligible studies with 1184 patients 
      between 12 and 80 years of age were included in RCTs analysis. Fifteen adverse 
      events were investigated. In this first part of the analysis, no adverse events 
      were statistically significantly associated with zonisamide. In the non-RCT 
      analysis, a high incidence of weight loss and headache was found. In RCTs, 
      zonisamide was statistically significantly associated with an increased risk of 
      adverse event-related study withdrawals [RR (99% CI) = 1.81 (1.07-3.08)]. 
      Although our study revealed no statistically significantly associated adverse 
      effects (AEs) with zonisamide, this is very likely a consequence of the small 
      numbers in the RCTs available. The limited data available from the studies appear 
      to reveal no major safety concerns related to zonisamide. However, the high 
      incidence of weight loss and headache in the non-RCTs suggests that these AEs 
      could be of clinical significance.
CI  - (c) 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Verrotti, A
AU  - Verrotti A
AD  - Department of Paediatrics, University of Chieti, Chieti, Italy.
FAU - Loiacono, G
AU  - Loiacono G
FAU - Di Sabatino, F
AU  - Di Sabatino F
FAU - Zaccara, G
AU  - Zaccara G
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20130613
PL  - Denmark
TA  - Acta Neurol Scand
JT  - Acta neurologica Scandinavica
JID - 0370336
RN  - 0 (Anticonvulsants)
RN  - 0 (Isoxazoles)
RN  - 459384H98V (Zonisamide)
SB  - IM
MH  - Anticonvulsants/*adverse effects
MH  - Clinical Trials as Topic
MH  - Databases, Factual/statistics & numerical data
MH  - Epilepsy/drug therapy
MH  - Humans
MH  - Isoxazoles/*adverse effects
MH  - Zonisamide
OTO - NOTNLM
OT  - antiepileptic drug
OT  - meta-analysis
OT  - safety
OT  - systematic review
OT  - zonisamide
EDAT- 2013/06/15 06:00
MHDA- 2014/11/05 06:00
CRDT- 2013/06/15 06:00
PHST- 2013/04/17 00:00 [accepted]
PHST- 2013/06/15 06:00 [entrez]
PHST- 2013/06/15 06:00 [pubmed]
PHST- 2014/11/05 06:00 [medline]
AID - 10.1111/ane.12147 [doi]
PST - ppublish
SO  - Acta Neurol Scand. 2013 Nov;128(5):297-304. doi: 10.1111/ane.12147. Epub 2013 Jun 
      13.