Abstract
There has been controversy over the cardiovascular safety of domperidone, attributable to the lack of a well-designed study as well as inconsistent results. This study aimed to examine the risk of severe domperidone-induced ventricular arrhythmia (VA), compared to mosapride, itopride, or non-use of all three prokinetics, in the general population. We conducted a population-based, self-controlled case series analysis. Enrolled subjects were individuals who were diagnosed with severe VA and were prescribed domperidone, mosapride, or itopride from 2003 to 2013 in the National Health Insurance Service-National Sample Cohort. The incidence rate ratio for severe VA was measured during exposure to prokinetics and compared with unexposed periods and itopride (no-proarrhythmic effect)-exposure periods, as control. A total of 2,817 subjects were included. Domperidone, mosapride, or itopride use was associated with increased risk of severe VA, compared with non-use (adjusted incidence rate ratios (IRR) of 1.342 (95% CI 1.096–1.642), 1.350 (95% CI 1.105–1.650), and 1.486 (95% CI 1.196–1.845), respectively). The risk of severe domperidone-induced VA was lower, compared to that of itopride [adjusted IRR of 0.548 (95% CI 0.345–0.870)]. Of the subjects who had been prescribed all three prokinetics, domperidone-exposure was associated with a lower risk of severe VA, compared to itopride-exposure (crude IRR, 0.571; 0.358–0.912). Mosapride-exposure did not show IRR difference for severe VA, compared to itopride-exposure. Domperidone, mosapride, or itopride use is associated with an increased risk of severe VA. However, the magnitude of association was modest and domperidone use does not increase further the risk, compared with other prokinetics.
Highlights
There has been controversy over the cardiovascular safety of domperidone, attributable to the lack of a well-designed study as well as inconsistent results
Of late, given that several case reports and retrospective studies have reported an association between domperidone and severe ventricular arrhythmia (VA), its use has been strictly restricted
Some meta-analyses indicate that domperidone may not be associated with the risk of overall cardiovascular (CV) events and QT prolongation[15,16,17], many clinicians hesitate to prescribe it to their patients
Summary
There has been controversy over the cardiovascular safety of domperidone, attributable to the lack of a well-designed study as well as inconsistent results. This study aimed to examine the risk of severe domperidone-induced ventricular arrhythmia (VA), compared to mosapride, itopride, or non-use of all three prokinetics, in the general population. Domperidone, mosapride, or itopride use was associated with increased risk of severe VA, compared with non-use (adjusted incidence rate ratios (IRR) of 1.342 (95% CI 1.096–1.642), 1.350 (95% CI 1.105–1.650), and 1.486 (95% CI 1.196–1.845), respectively). Of the subjects who had been prescribed all three prokinetics, domperidone-exposure was associated with a lower risk of severe VA, compared to itopride-exposure (crude IRR, 0.571; 0.358–0.912). Exhibits concomitant central antiemetic activity through dopamine receptors within the chemoreceptor trigger z one[5] Despite all these advantages, the clinical use of oral domperidone is currently limited to individuals with an FDA Investigational New Drug exemption (treatment-refractory gastroparesis), owing to the risk of severe ventricular arrhythmia (VA)[2]. Variables Age groups 0–14 15–29 30–44 45–59 60–74 75 + Sex Male Underlying disease Structural heart disease Hypertension Diabetes mellitus Dyslipidemia Arrhythmia Number of prokinetics users Domperidone Mosapride Itopride
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
