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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

Pediatrics
|November 4, 2000
PubMed

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.
Abstract

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