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The effect of cisapride on the corrected QT interval and QT dispersion in premature infants

F Cools1, A Benatar, A Bougatef

  • 1Academic Hospital, Free University of Brussels, Brussels, Belgium. Filip.Cools@az.vub.ac.be

Journal of Pediatric Gastroenterology and Nutrition
|September 25, 2001
PubMed

Insights

Premature infants show increased cardiac risk with cisapride due to prolonged QT interval (QTc). Higher drug levels and QTc prolongation suggest a need for dose reduction and close monitoring in neonates.

Area of Science:

  • Neonatal pharmacology
  • Pediatric cardiology
  • Clinical pharmacokinetics

Background:

  • Cisapride is a common gastrointestinal prokinetic agent for neonates.
  • Concerns exist regarding cisapride's safety profile, particularly its effect on the QT interval.
  • Premature infants may be more susceptible to adverse effects due to physiological immaturity.

Purpose of the Study:

  • To investigate the pharmacokinetics of cisapride.
  • To assess the effects of cisapride on the corrected QT interval (QTc) and QT dispersion in premature infants.
  • To compare cisapride's safety profile in premature versus term infants.

Main Methods:

  • Prospective study involving 10 premature infants treated with cisapride (0.2 mg/kg/dose, 4x daily).
  • Electrocardiogram (ECG) monitoring before and after 72 hours of treatment.
  • Quantification of cisapride and norcisapride plasma levels and comparison with 41 term infants.

Main Results:

  • Significant increase in QTc interval (423 ms to 461 ms) in premature infants (P = 0.0007).
  • No significant change in QT dispersion observed.
  • Higher cisapride and norcisapride plasma levels in premature infants compared to term infants (P < 0.001).
  • QTc prolongation inversely correlated with postnatal age (P = 0.02).

Conclusions:

  • Premature infants (<1 month) face elevated cardiac risk with standard cisapride dosage.
  • Recommended cisapride dose reduction to 0.1 mg/kg/dose, 4x daily, with close QTc monitoring.
  • Re-evaluation of cisapride's benefit-risk balance in very young premature infants is warranted.
Abstract

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