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QT interval in children and infants receiving cisapride
A Levine1, R Fogelman, L Sirota
1Division of Gastroenterology and Nutrition, the Division of Cardiology, Schneider Children's Medical Center of Israel, Tel Aviv University Sackler School of Medicine, Petah Tikva, Israel.
Insights
This study found that prolonged cisapride therapy did not significantly alter the corrected QT interval in premature infants and children. Cisapride appears safe for use in these populations when other risk factors are absent.
Area of Science:
- Pediatric Pharmacology
- Cardiology
- Neonatology
Background:
- Cisapride, a drug similar to procainamide, has been linked to life-threatening arrhythmias and QT prolongation in adults and children.
- Premature infants exhibit reduced cytochrome P450 activity, potentially impairing cisapride metabolism and increasing the risk of QT prolongation.
Purpose of the Study:
- To prospectively investigate the effect of prolonged cisapride therapy on the QT interval in premature infants and children.
- To assess the safety of cisapride use in pediatric populations with potential metabolic differences.
Main Methods:
- Electrocardiography (ECG) was used to measure the corrected QT interval in 30 premature infants and children before and after one month of cisapride therapy (0.8 mg/kg/day).
- Participants were recruited from a neonatal intensive care unit and a pediatric gastroenterology clinic.
Main Results:
- The mean corrected QT interval remained similar between baseline and one month of cisapride therapy.
- No significant QT prolongation or adverse effects were observed during the study period.
Conclusions:
- Prolonged cisapride therapy at the studied dosage (0.8 mg/kg/day) did not demonstrate a trend toward QT prolongation in premature infants and children.
- Cisapride may be considered safe for use in premature infants and children, provided no other risk factors for altered metabolism or arrhythmia are present.
- Further research is recommended to validate these findings.
Objectives:
Life-threatening arrhythmias and prolonged QT interval have been reported in adults and children using cisapride, a medication structurally similar to procainamide. Premature infants have reduced activity of cytochrome p-450, the system responsible for metabolism of cisapride, which could lead to QT prolongation. Therefore, we prospectively studied premature infants and children receiving cisapride to analyze the effect of prolonged cisapride therapy on QT interval.
Design:
Premature infants in a neonatal intensive care unit and children seen at a pediatric gastroenterology clinic in a tertiary care hospital had electrocardiography-analyzed and -corrected QT interval measured before cisapride (0.8/mg/kg per day) therapy, and again after 1 month of therapy. If baseline electrocardiography was not performed initially, it was obtained after cessation of therapy.
Results:
A total of 30 children participated in the study. Mean corrected QT interval was similar at baseline and at 1 month after therapy. Significant QT prolongation was not found, and no adverse effects were recorded.
Conclusions:
Corrected QT interval during prolonged cisapride therapy at 0.8 mg/kg per day appears to be similar for premature infants and children. An inherent trend toward QT prolongation was not detected in either group. In the absence of other risk factors that alter cisapride metabolism or predispose to arrhythmia, cisapride may be safe for use in premature infants as well as in children. Additional studies are needed to confirm these data.