However, in pacemaker dependency (with ventricular pacing from the Non‐specific, flat T‐wave abnormalities were observed in one participant each in the placebo and domperidone 20 mg groups and two participants each in the domperidone 10 mg and moxifloxacin groups. Many medicines have not been tested for this risk in patients, especially those with €€€€ For both doses of domperidone, the difference in mean change from baseline in QT intervals between domperidone and placebo ranged from −3.6 to 3.6 milliseconds. After a moxifloxacin dose, one participant had a >30 milliseconds increase from baseline QTcP value at 5 hours post‐dose on Day 1 (412.6–443.5 milliseconds).ECG morphology abnormalities occurred infrequently, were balanced in frequency across the treatment groups, and were all determined to be clinically insignificant in blinded review. The authors acknowledge the support of Ineke Naessens, Ann Gys, Patrick Malyszewska, Wieb Reddingius, and Frederic Saad (all from Janssen Research & Development) in the management of the study and processing of the data thereof. Solid line represents linear model without intercept with concentration as a predictor and subject as a random effect. The most common events (i.e., reported in ≥5% patients in any treatment group) were skin irritation at the site of ECG electrodes application, which was reported in 5 (11.9%) of 42 participants in the placebo treatment group, and headache in 3 (7.1%) of 42 participants in moxifloxacin 400 mg treatment group. Comparative study on the excretion and metabolism of domperidone in rats, dogs and manA rabbit Langendorff heart proarrhythmia model: predictive value for clinical identification of Torsades de PointesLow safety index of domperidone: mechanism for increased odds ratio for sudden cardiac deathDomperidone: limited benefits with significant risk for sudden cardiac deathRisk of domperidone induced severe ventricular arrhythmia, Apomorphine therapy: alternative initiation for patients with complex Parkinson's disease presentation, Cardiovascular alterations in rats with Parkinsonism induced by 6-OHDA and treated with Domperidone, What Evidence Do We Have for Pharmaceutical Galactagogues in the Treatment of Lactation Insufficiency?—A Narrative Review, Does domperidone prolong QTc in a clinically relevant manner in infants with GORD?, Drug–drug interactions in patients undergoing chemoradiotherapy and the impact of an expert team intervention, Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe, A meta-analysis on the cardiac safety profile of domperidone compared to metoclopramide, Randomized clinical trials and observational studies in the assessment of drug safety, Severe Proarrhythmic Potential of the Antiemetic Agents Ondansetron and Domperidone, Thorough QT (TQT) studies: concordance with torsadogenesis and an evolving cardiac safety testing paradigm, Prokinetics in the Management of Functional Gastrointestinal Disorders, Domperidone for Hypotension in Parkinson’s Disease: A Systematic Review,
Typically, development of severe QT prolongation or TdP requires several precipitating absence of drugs from these lists should not be considered an indication that they are free of risk of QT prolongation or torsades de pointes. They might also do tests to see if you have electrolyte imbalances in You may also need to temporarily wear a device that tracks your heart rhythm as you go about your daily routine.
The study is registered at In each treatment period, serial 12‐lead ECGs were recorded in triplicate during the first dosing interval at 30, 20, and 10 minutes before dosing on Day 1 (the average of which was defined as baseline), at 10 minutes before dosing (predose) on Day 4, and at 8 (0.5, 1, 1.5, 2, 2.5, 3, 4, 5 hours) post‐dose timepoints on Days 1 and 4, always before PK sampling. On Day 4, mean heart rate values for the respective treatment groups ranged from 60.1 to 64.7, 57.8 to 64.5, 59.4 to 64.4, and 59.3 to 64.4 bpm. One participant (baseline value 443.1 milliseconds) had two QTcP intervals >450 milliseconds measured during domperidone 10 mg treatment—456.1 at 3 hours post‐dose on Day 1 and 452.5 milliseconds at 5 hours post‐dose on Day 4.
The 95% CI for the difference in mean change from baseline in QT intervals between domperidone and placebo included 0 millisecond on both days and at all timepoints.QTcP was selected as the primary correction method (correction factor = 0.2434).