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

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.

• Authors: Mario Fioravanti, Taku Nakashima, Jun Xu, Amit Garg
• Journal: BMJ open (BMJ Open) Vol. 4 Issue 7 Pg. e005090 (Jul 30 2014) ISSN: 2044-6055 [Print] England
• PMID: 25079927 (Publication Type: Journal Article, Meta-Analysis, Review, Systematic Review)
• Copyright: 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.

Chemical References

• Adrenergic alpha-Antagonists
• Neuroprotective Agents
• Nicergoline

Topics

• Adrenergic alpha-Antagonists (adverse effects)
• Brain Diseases (drug therapy)
• Humans
• Neuroprotective Agents (adverse effects)
• Nicergoline (adverse effects)
• Peripheral Vascular Diseases (drug therapy)
• Randomized Controlled Trials as Topic