No QT prolongation or ventricular arrhythmia- Study confirms cardiac safety of Domperidone
USA: Domperidone is a dopamine receptor antagonist used for gastroparesis treatment. However, its use has been associated with some serious safety concerns including QT prolongation, ventricular arrhythmias, and sudden cardiac death. Now, a recent study published in the Journal of Clinical Gastroenterology has put to rest all the concerns suggesting that domperidone can be safely prescribed at doses of 30 to 80 mg daily for the treatment of gastroparesis.
It was found that domperidone at the dose of 30 to 80 mg daily resulted in QT prolongation in only 6% of the patients and no QT interval reached the point considered to be clinically significant.
Justin Field, Temple University School of Medicine, Philadelphia, PA, and colleagues conducted the study to determine the effect and safety of domperidone on QTc interval at the commonly prescribed doses of 30 to 80 mg daily.
The study included 246 patients (age, 46.3±17.4 y; females 209) who were prescribed domperidone for treatment of gastroparesis between January 2012 and September 2017 at a single centre. The study reviewed electrocardiograms (EKGs) primarily the QTc interval, taken at baseline, 2 to 6 months after initiation of domperidone, 6 to 12 months after initiation, and ≥12 months after initiation. Concurrent QTc prolonging medications were recorded for each patient.
The primary endpoint was QTc prolongation >500 ms. Secondary endpoints were QTc >450 ms for males, a QTc>470 ms for females, QTc prolongation ≥20 ms above baseline, and QTc prolongation >60 ms above baseline.
Key findings include:
- EKGs were available for all 246 patients before treatment, 170 patients at 2 to 6 months, 135 at 6 to 12 months, and 152 patients at least 1 year after domperidone initiation.
- Of 246 subjects, 15 patients (6.1%, 9 female) had clinically important QTc prolongation; 11 had QTc >450 ms for males or >470 ms for females; none had QTc prolongation >500 ms; 5 (2.0%) had >60 ms over baseline and 61 (24.7%) patients had QTc increase of ≥20 ms but <60 ms from baseline.
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"Domperidone at the conventionally used doses to treat gastroparesis (30 to 80 mg/d) was associated with QTc prolongation in only 6% of patients with no QT interval reaching the point considered to be clinically significant," wrote the authors.
"These data suggest that domperidone can be safely prescribed at doses of 30 to 80 mg daily for the treatment of gastroparesis," they concluded.
To read the study in detail log on to doi: 10.1097/MCG.0000000000001183