Document Detail


The effect of cisapride on the corrected QT interval and QT dispersion in premature infants.
MedLine Citation:
PMID:  11568520     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Cisapride is used frequently in premature neonates as a gastrointestinal prokinetic drug. Concerns exist, however, about its safety because of its effect on the QT interval. Premature infants could be at higher risk for side effects because of their immaturity. This prospective study investigated the pharmacokinetics of cisapride and its effects on corrected QT interval (QTc) and QT dispersion in premature infants. METHODS: Electrocardiogram examination was performed just before and after 72 hours of treatment with cisapride (0.2 mg/kg per dose, four times daily) in 10 premature infants. Trough and anticipated peak plasma level of cisapride and norcisapride were quantified after 72 hours of treatment. Results were compared with a cohort of 41 term infants aged 0 to 3 months receiving cisapride treatment. RESULTS: The QTc interval increased significantly from 423 ms to 461 ms after 72 hours of treatment (P = 0.0007). No effect was seen on QT dispersion (44.3 ms vs. 45.9 ms). The change in QTc interval was inversely related to postnatal age (R2 = 0.52; P = 0.02), whereas there was no correlation with gestational age or plasma levels of cisapride or norcisapride. Trough and anticipated peak plasma levels of cisapride and norcisapride were significantly higher in the premature infants compared with the term infants aged 0 to 3 months (P < 0.001). CONCLUSIONS: Premature infants less than 1 month of age could be at higher risk for cardiac side effects of cisapride when used in the same dosage as in older infants. The daily dose should be reduced (0.1 mg/kg per dose, maximum four times daily), and the QTc interval should be monitored closely. The benefits and safety of cisapride in premature infants less than 1 month of age should be reconsidered.
Authors:
F Cools; A Benatar; A Bougatef; Y Vandenplas
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of pediatric gastroenterology and nutrition     Volume:  33     ISSN:  0277-2116     ISO Abbreviation:  J. Pediatr. Gastroenterol. Nutr.     Publication Date:  2001 Aug 
Date Detail:
Created Date:  2001-09-24     Completed Date:  2001-10-25     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8211545     Medline TA:  J Pediatr Gastroenterol Nutr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  178-81     Citation Subset:  IM    
Affiliation:
Academic Hospital, Free University of Brussels, Brussels, Belgium. Filip.Cools@az.vub.ac.be
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Case-Control Studies
Cisapride / adverse effects*,  pharmacokinetics,  therapeutic use
Cohort Studies
Electrocardiography / drug effects*
Gastrointestinal Agents / adverse effects*,  pharmacokinetics,  therapeutic use
Gastrointestinal Diseases / drug therapy*
Heart / drug effects,  physiology*
Humans
Infant, Newborn
Infant, Premature
Prospective Studies
Safety
Chemical
Reg. No./Substance:
0/Gastrointestinal Agents; 81098-60-4/Cisapride

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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