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Efficacy and tolerability of cisapride in children
Y Vandenplas1, A Benatar, F Cools
1Academic Children's Hospital, Free University of Brussels, Belgium.yvan.vandenplas@az.vub.ac.be
Insights
Cisapride is a beneficial prokinetic for infants and children with gastro-oesophageal reflux disease (GORD). When used with precautions, its benefits outweigh risks, preventing severe complications in pediatric gastrointestinal motility disorders.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Gastro-oesophageal reflux disease (GORD) in children is a motility disorder distinct from adult GORD.
- Prokinetic agents are indicated in specific pediatric GORD cases.
Purpose of the Study:
- To evaluate cisapride as a prokinetic agent for pediatric gastrointestinal motility disorders.
- To assess the benefit-to-risk ratio of cisapride in infants and children.
Main Methods:
- Review of published data on cisapride in pediatric GORD and motility disorders.
- Analysis of cisapride's efficacy, tolerability, and safety profile, including QTc-prolonging effects.
Main Results:
- Cisapride improves feeding tolerance in premature infants.
- While cisapride may prolong QTc, this effect is clinically insignificant when administered with precautions.
- Cisapride demonstrates a favorable tolerability profile compared to other options.
Conclusions:
- Cisapride is the prokinetic with the best available benefit-to-risk ratio for pediatric GORD and motility disorders.
- Withdrawal of cisapride increases the risk of severe complications in affected children.
- Adherence to correct dosage and avoiding concurrent macrolide/azole use are crucial for cisapride safety in children.
Abstract:
As gastro-oesophageal reflux disease (GORD) in infants and children is a motility disorder which differs in pathophysiology and clinical course from GORD in adults, prokinetics should be considered the drug of choice in certain circumstances. Indeed, cisapride may result in improvement of feeding tolerance in premature infants. Cisapride has a better tolerability profile than a 'wait-and-see-if-improvement-comes-spontaneously' policy or the other therapeutic options available. A careful and critical review of published data suggests that cisapride may have a QTc-prolonging effect. However, provided the precautions for cisapride administration are followed, the QTc-prolonging effect remains consistently without clinically relevant adverse effects. Correct dosage and avoidance of concurrent treatment with macrolides and/or azoles are the most relevant tolerability recommendations in children. Although there is a need for a prokinetic with better efficacy, cisapride is currently the prokinetic with the best benefit-to-risk ratio available. Thus, withdrawal of cisapride would result in a significantly increased risk for severe complications in infants and children with GORD or other gastrointestinal motility disorders such as chronic intestinal pseudo-obstruction, gastroparesis and feed intolerance in premature infants.