Domperidone-Associated Sudden Cardiac Death in the General Population and Implications for Use in Patients Undergoing Hemodialysis: A Literature Review

Makari, Joy; Cameron, Karen; Battistella, Marisa

doi:10.4212/cjhp.v67i6.1407

Cited by 5 publications

(2 citation statements)

References 15 publications

(31 reference statements)

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“…Epidemiological studies showed that domperidone use might be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death without proving causality. 8,13,14,24 However, studies suggest that the increased cardiac risk may be higher in patients >60 years of age or in patients taking oral doses >30 mg/day. 25 Therefore, domperidone should be used with caution in older patients, and the physicians should be consulted before domperidone use.…”

Section: Discussionmentioning

confidence: 99%

Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China

Wang

Nie²,

Yang

et al. 2022

Clinical Pharm in Drug Dev

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This study aimed to evaluate the QT prolongation potential of domperidone in healthy Chinese participants and explore the possibility of a thorough QT (TQT) study in China with a smaller sample size using concentration-QT (C-QT) modeling. Part 1 was a randomized, placebo-and positive-controlled, multiple-dose, 4-way crossover TQT study in healthy Chinese participants; 44 participants were randomized to either domperidone 10/20 mg or placebo 3 times daily, on days 1 to 3, followed by a single dose of either 10/20 mg domperidone/domperidone-placebo/domperidone-placebo plus 400 mg of moxifloxacin, on day 4. Twelve-lead electrocardiograms were recorded in triplicate at predefined time points with pharmacokinetic sampling. The results were that change from baseline in QT interval corrected for heart rate (QTc) using the Fridericia formula (QTcF) between domperidone and placebo was 1.3 milliseconds and 2.7 milliseconds for 10 and 20 mg 3 times daily, and upper limits of 2-sided 90%CI for all time points were below regulatory threshold of 10 milliseconds. In part 2, resampling analysis using C-QT modeling for moxifloxacin showed false-negative rates of <5% with sample sizes ≥6. We could conclude that no clinically relevant effect on corrected QT interval or new safety signals was observed with domperidone. A dedicated TQT study with C-QT modeling could assess drug effects on QT/corrected QT intervals for novel drug development in China.

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Section: Discussionmentioning

confidence: 99%

Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China

Wang

Nie²,

Yang

et al. 2022

Clinical Pharm in Drug Dev

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“…There is no evidence that patients with end-stage renal disease are at increased risk of adverse effects of prokinetic agents [51,52]. However, given potential severe adverse effects, use of the agents should be assessed on a case-by-case basis [51,53,54].…”

Section: Gastroparesis Among Patients With End-stage Kidney Diseasementioning

confidence: 99%

Dietary modifications achieved successful resolution of symptoms of gastroparesis diagnosed by demonstrating gastric food retention after overnight fasting in diabetic dialysis patients: two case reports with literature review

Eguchi¹

2020

Ren Replace Ther

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Background Gastroparesis is frequently overlooked and difficult to treat. The diagnosis of gastroparesis requires standard upper gastrointestinal endoscopy to exclude gastric outlet obstruction and objective evidence demonstrating delayed gastric emptying. However, none of the internationally recommended methods for measuring gastric emptying including scintigraphy are covered by the Japanese health insurance system. Limitations in the diagnosis might be related to the disease being overlooked in Japan. Meanwhile, presence of retained food in the stomach after overnight fasting without obstruction is classically known to be suggestive of gastroparesis. Some recent reports have considered gastric food retention after an overnight fasting equivalent to delayed gastric emptying. Case presentation Two diabetic dialysis patients presented with nausea, vomiting, and oral feeding intolerance in the absence of mechanical obstruction. Abdominal computed tomography, upper gastrointestinal endoscopy, and ultrasonography demonstrated gastric food retention after overnight fasting. The findings led to the diagnosis of gastroparesis. Appropriate dietary modifications alone successfully relieved the symptoms despite persistent delayed gastric emptying. Conclusions Demonstrating retained food residue after fasting for sufficient duration might be a diagnostic alternative. Dietary modifications alone provided significant clinical benefits. Possible approaches for the diagnosis and treatment of gastroparesis in Japan should be investigated.

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Prevalence of potentially inappropriate medications in older adults in Argentina using Beers criteria and the IFAsPIAM List

et al. 2019

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Domperidone-Associated Sudden Cardiac Death in the General Population and Implications for Use in Patients Undergoing Hemodialysis: A Literature Review

Abstract: Background: Domperidone, an effective prokinetic agent, is commonly used to manage symptoms of gastroparesis. Health regulatory agencies have issued warnings about an increased risk of sudden cardiac death associated with use of this drug.

Cited by 5 publications

References 15 publications

Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China

Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China

Dietary modifications achieved successful resolution of symptoms of gastroparesis diagnosed by demonstrating gastric food retention after overnight fasting in diabetic dialysis patients: two case reports with literature review

Prevalence of potentially inappropriate medications in older adults in Argentina using Beers criteria and the IFAsPIAM List

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