PMID- 25079927
OWN - NLM
STAT- MEDLINE
DCOM- 20150309
LR  - 20211021
IS  - 2044-6055 (Print)
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 4
IP  - 7
DP  - 2014 Jul 30
TI  - A systematic review and meta-analysis assessing adverse event profile and 
      tolerability of nicergoline.
PG  - e005090
LID - 10.1136/bmjopen-2014-005090 [doi]
LID - e005090
AB  - OBJECTIVE: To evaluate the safety profile of nicergoline compared with placebo 
      and other active agents from published randomised controlled trials. DESIGN: 
      Systematic review and meta-analysis of nicergoline compared with placebo and 
      other active agents across various indications. DATA SOURCES: MEDLINE, 
      Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of 
      Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and 
      Cochrane Methodology Register (CMR) for all the randomised controlled trials, 
      open-label or blinded, in adults treated with nicergoline. Studies published 
      until August 2013 were included. REVIEW METHOD: 29 studies were included for data 
      extraction. The studies included in this review were majorly from European 
      countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). 
      RESULTS: The treatment withdrawals were comparatively lower in the nicergoline 
      group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other 
      active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was 
      non-significant. Incidence of any adverse events (AEs) was slightly higher 
      (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 
      95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of 
      anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). 
      Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less 
      frequent in the nicergoline group when compared with placebo/active drugs, but 
      the difference was non-significant. Frequency of hypotension and hot flushes was 
      slightly higher in the nicergoline group but the difference was non-significant. 
      None of the studies reported any incidence of fibrosis or ergotism with 
      nicergoline treatment. CONCLUSIONS: Nicergoline is an ergot derivative, but its 
      safety profile is better than other ergot derivatives like ergotamine and 
      ergotoxine. This systematic review and meta-analysis suggests that nicergoline 
      has a good safety profile. None of the studies included in this systematic review 
      reported any incidence of fibrosis or ergotism with nicergoline.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Fioravanti, Mario
AU  - Fioravanti M
AD  - Department of Neurology and Psychiatry, University Hospital, Umberto I, 
      University of Rome, Sapienza, Italy.
FAU - Nakashima, Taku
AU  - Nakashima T
AD  - Department of Molecular & Internal Medicine, Hiroshima University Hospital, 
      Hiroshima, Japan.
FAU - Xu, Jun
AU  - Xu J
AD  - Jiangsu Province Geriatric Hospital, Jiangsu, China.
FAU - Garg, Amit
AU  - Garg A
AD  - Hyderabad, Andhra Pradesh, India.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20140730
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Adrenergic alpha-Antagonists)
RN  - 0 (Neuroprotective Agents)
RN  - JCV8365FWN (Nicergoline)
SB  - IM
MH  - Adrenergic alpha-Antagonists/*adverse effects
MH  - Brain Diseases/drug therapy
MH  - Humans
MH  - Neuroprotective Agents/adverse effects
MH  - Nicergoline/*adverse effects
MH  - Peripheral Vascular Diseases/drug therapy
MH  - Randomized Controlled Trials as Topic
PMC - PMC4120366
OTO - NOTNLM
OT  - Ergot derivatives
OT  - Ergotism
OT  - Fibrosis
OT  - Meta-analysis
OT  - Nicergoline
EDAT- 2014/08/01 06:00
MHDA- 2015/03/10 06:00
PMCR- 2014/07/30
CRDT- 2014/08/01 06:00
PHST- 2014/08/01 06:00 [entrez]
PHST- 2014/08/01 06:00 [pubmed]
PHST- 2015/03/10 06:00 [medline]
PHST- 2014/07/30 00:00 [pmc-release]
AID - bmjopen-2014-005090 [pii]
AID - 10.1136/bmjopen-2014-005090 [doi]
PST - epublish
SO  - BMJ Open. 2014 Jul 30;4(7):e005090. doi: 10.1136/bmjopen-2014-005090.