Literature DB >> 11099628

Effects of cisapride on corrected QT interval, heart rate, and rhythm in infants undergoing polysomnography.

A Benatar1, A Feenstra, T Decraene, Y Vandenplas.   

Abstract

OBJECTIVE: To evaluate the effects of cisapride, a prokinetic gastrointestinal drug, on the electrocardiographic QT interval, heart rate, and rhythm in infants during routine 8-hour polysomnography. Reported electrocardiogram (ECG) and rhythm disturbances in a small number of patients with the use of cisapride provided the impetus for this prospective study. STUDY
DESIGN: Two hundred fifty-two infants born at term were enrolled. Of these, 134 were on cisapride therapy for suspected gastroesophageal reflux and 118 were not on cisapride and served as controls. Cisapride-treated and control infants were from the outset divided into 3 age groups; group 1: under 3 months of age; group 2: between 3 and 6 months of age; and group 3: >6 months of age. Continuous ECG bipolar limb lead I recording, saturation monitoring, and electroencephalography were conducted. QT intervals and heart rate were measured at hourly intervals.
RESULTS: Cisapride doses were: group 1 mean, 0.80 mg/kg/day (range: 0.38-1.55); group 2 mean, 0.80 mg/kg/day (range: 0. 23-1.38); and group 3 mean, 0.72 mg/kg/day (range: 0.32-1.41). Heart rate was higher in the younger infants, with a gradual decrease with age. No difference in heart rate was detected between the cisapride and control groups. The QTc interval in patients in group 1 was statistically longer than the controls, when applying both Bazett's and Hodges' formulae for QT correction. The other age groups did not differ. No arrhythmia or atrioventricular conduction abnormalities were observed.
CONCLUSION: Infants under 3 months of age on cisapride treatment had significantly longer QTc intervals (with Bazett's formula, the 98th percentile was 504 ms in the cisapride group vs 447 ms in controls). The clinical significance and risk of the increased QTc interval in these infants are unclear and need further evaluation and risk stratification. Meanwhile, cisapride should be judiciously prescribed in infants <3 months of age.

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Year:  2000        PMID: 11099628     DOI: 10.1542/peds.106.6.e85

Source DB:  PubMed          Journal:  Pediatrics        ISSN: 0031-4005            Impact factor:   7.124


  6 in total

1.  A comparison of the pharmacokinetics of two dosing regimens of cisapride and their effects on corrected QT interval in premature infants.

Authors:  Filip Cools; Avram Benatar; Els Bruneel; Claire Theyskens; Adel Bougatef; Ann Casteels; Yvan Vandenplas
Journal:  Eur J Clin Pharmacol       Date:  2003-04-01       Impact factor: 2.953

2.  Acquired drug-induced long QTc: new insights coming from a retrospective study.

Authors:  Renato De Vecchis; Carmelina Ariano; Giuseppina Di Biase; Michel Noutsias
Journal:  Eur J Clin Pharmacol       Date:  2018-08-15       Impact factor: 2.953

3.  Application of the bradford hill criteria to assess the causality of cisapride-induced arrhythmia: a model for assessing causal association in pharmacovigilance.

Authors:  Michael Perrio; Simon Voss; Saad A W Shakir
Journal:  Drug Saf       Date:  2007       Impact factor: 5.606

Review 4.  Efficacy and tolerability of cisapride in children.

Authors:  Y Vandenplas; A Benatar; F Cools; A Arana; B Hegar; B Hauser
Journal:  Paediatr Drugs       Date:  2001       Impact factor: 3.022

5.  The measurement of the QT and QTc on the neonatal and infant electrocardiogram: a comprehensive reliability assessment.

Authors:  Robert M Gow; Benjamin Ewald; Lillian Lai; Letizia Gardin; Jane Lougheed
Journal:  Ann Noninvasive Electrocardiol       Date:  2009-04       Impact factor: 1.468

6.  Malignant Ventricular Arrhythmias Resulting From Drug-Induced QTc Prolongation: A Retrospective Study.

Authors:  Renato De Vecchis; Carmelina Ariano; Giuseppina Di Biase; Michel Noutsias
Journal:  J Clin Med Res       Date:  2018-06-04
  6 in total

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