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Clin Drug Investig. 2016 Feb;36(2):97-107. doi: 10.1007/s40261-015-0360-0.

Domperidone and Risk of Ventricular Arrhythmia and Cardiac Death: A Systematic Review and Meta-analysis.

Author information

1
Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, 115 South Grand Avenue, PHAR 201, Iowa City, IA, 52242-1112, USA. nattawut-leelakanok@uiowa.edu.
2
Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA.
3
Division of General Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.
4
Iowa City VA Health Care System, Iowa City, IA, USA.

Abstract

BACKGROUND AND OBJECTIVE:

Domperidone is a drug used globally for relieving nausea and vomiting and stimulating breast milk production. Several case reports and studies linked domperidone usage with major cardiovascular adverse events (cardiac arrhythmia and sudden cardiac death). However, multiple randomized controlled efficacy studies failed to detect such adverse events. Our objectives were to systematically review and meta-analyze the association between current domperidone exposure and cardiovascular adverse events.

METHODS:

The first author performed EMBASE, PubMed and Scopus searches to identify human studies assessing the association between current domperidone exposure and cardiac arrhythmia or sudden death. Thirteen related articles were identified and the first and second authors independently reviewed the articles. Six studies were included in the final analysis. Meta-analysis was performed with a random effect model using the inverse variance approach. Heterogeneity was evaluated using the Q statistic and I(2) test.

RESULTS:

Five case-control studies and one case-crossover study were included in this meta-analysis. Pooled risk estimates demonstrated that the current use of domperidone increased the risk of ventricular arrhythmia and sudden cardiac death (pooled adjusted odds ratio = 1.70; 95% confidence interval 1.47-1.97; I(2) = 0%). The I(2) test showed that the underlying population was homogeneous.

CONCLUSIONS:

Evidence from this meta-analysis suggests that current domperidone use increases the risk of cardiac arrhythmia and sudden cardiac death by 70%. Domperidone usage in older populations should be discouraged. Larger observational studies or randomized controlled trials are needed to confirm the findings of this analysis.

PMID:
26649742
DOI:
10.1007/s40261-015-0360-0
[Indexed for MEDLINE]

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