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BMJ Open. 2014 Jul 30;4(7):e005090. doi: 10.1136/bmjopen-2014-005090.

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline.

Author information

1
Department of Neurology and Psychiatry, University Hospital, Umberto I, University of Rome, Sapienza, Italy.
2
Department of Molecular & Internal Medicine, Hiroshima University Hospital, Hiroshima, Japan.
3
Jiangsu Province Geriatric Hospital, Jiangsu, China.
4
Hyderabad, Andhra Pradesh, India.

Abstract

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.

KEYWORDS:

Ergot derivatives; Ergotism; Fibrosis; Meta-analysis; Nicergoline

PMID:
25079927
PMCID:
PMC4120366
DOI:
10.1136/bmjopen-2014-005090
[Indexed for MEDLINE]
Free PMC Article

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