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Cisapride and QTc interval in children
J Ramírez-Mayans1, L M Garrido-García, A Huerta-Tecanhuey
1Gastroenterology and Nutrition Department, Instituto Nacional de Pediatría, Tertiary Referral Center, Mexico City, Mexico. jramay1@yahoo.com
Insights
Concerns about cisapride safety in children prompted this study. Electrocardiographic changes, specifically prolonged QT intervals (PQTI), were assessed; findings suggest PQTI is not definitively linked to cisapride use or life-threatening events in pediatric patients.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
Background:
- Safety concerns regarding cisapride use in children have been reported.
- This study aimed to evaluate electrocardiographic (ECG) changes and arrhythmia predisposition in pediatric patients treated with cisapride.
Purpose of the Study:
- To assess the incidence of electrocardiographic changes, particularly prolonged QT intervals (PQTI), in children receiving cisapride.
- To determine if cisapride use predisposes children to arrhythmias.
- To compare ECG parameters between children receiving cisapride and a control group.
Main Methods:
- A cohort of 63 children receiving cisapride (0.2 mg/kg/dose TID) was compared to 57 age-matched controls.
- Electrocardiograms (EKGs) were performed on all participants, with QT interval corrected using Bazett's formula (QTc).
- Children with PQTI underwent 24-hour Holter monitoring; cisapride was discontinued in affected patients in the treatment group.
Main Results:
- Prolonged QT intervals (PQTI) were observed in 5 children treated with cisapride and 6 controls.
- In 3 children with PQTI, discontinuation of cisapride led to normalization of the QTc interval.
- A statistically significant difference in QTc interval was noted in infants under 4 months, with longer intervals in the control group. Holter recordings were normal in all children with PQTI.
Conclusions:
- Prolonged QT intervals (PQTI) can occur in children regardless of cisapride use.
- The study did not find an association between PQTI and life-threatening events in the studied pediatric population.
- Cisapride discontinuation may normalize PQTI in some pediatric patients.
Background:
Recent reports about cisapride have raised some concerns about the safety and efficacy of this medication in children. The aim of this study was to identify electrocardiographic changes and a predisposition to develop arrhythmias in children.
Methods:
Patients were divided in 2 groups: 1) 63 children (mean age: 29 months) who received cisapride (0.2 mg/kg/dose 3 times/day), and 2) 57 children (mean age: 27 months) who did not receive cisapride (they served as controls). Both groups did not have any associated disease. Electrocardiogram (EKG) was performed to children when they were included in the study. The QT interval was corrected using Bazett's formula. Twenty-four-hour Holter recording was performed in children with prolonged QT interval (PQTI). When PQTI was identified in group 1, cisapride was discontinued and a new EKG was performed.
Results:
Five children from group 1 and 6 from group 2 had PQTI. In 3 children with PQTI, the QTc interval returned to normal values when cisapride was discontinued. In children under 4 months of age, a statistical difference was found, with QTc interval being longer in group 2 (without cisapride) than in group 1. Holter recordings were normal in all children with PQTI.
Conclusion:
PQTI can be found in normal children with or without cisapride. In our study PQTI was not associated with any life-threatening event.