Abstract
Background
Upper gastrointestinal (GI) symptoms are common in pediatrics, and few prokinetics for children exist. The goal of this study was to determine the efficacy of prucalopride for treatment of upper GI symptoms and feeding difficulties in children.
Methods
This was a retrospective study of patients prescribed prucalopride for upper GI symptoms at a single tertiary care center from July 2019 to January 2021. Demographic data, the indication for prucalopride, comorbidities, and feeding data were recorded. The primary outcome was improvement in the primary upper GI symptom at first follow-up after prucalopride initiation. Univariable and multivariable analyses were used to assess for factors associated with improvement.
Results
The final study population included 71 patients who received prucalopride for treatment of upper GI symptoms. The most common indications were nausea (44%), feeding difficulties (20%), and reflux (11%). Patients had a median age of 16.7 years (range 1.9–21.8 years), and they had received 4 ± 4.8 years of care in our GI clinic and trialed 3.0 ± 2.0 other GI medications by the time of the prucalopride prescription. At follow-up 3.6 ± 2.9 months after the prucalopride was prescribed, 46 patients (65%) had symptomatic improvement of the upper GI symptom. Improvement was more likely in patients with enteral tubes (p = 0.04), pulmonary comorbidities (p = 0.006), and neurologic comorbidities (p = 0.02). Amongst patients with feeding difficulties, 79% of patients showed improvements in oral or tube feeding.
Conclusions
In this sample of children treated for refractory upper GI symptoms at a single tertiary care center, patients showed improvements in symptoms like nausea, reflux, and feeding difficulties after starting prucalopride.
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Funding
Supported by National Institutes of Health R01 DK097112-01 and T32 DK007477-37.
Conflict of interest
Suzanna Hirsch, Samuel Nurko, Paul Mitchell, and Rachel Rosen declare that they have no conflicts of interest.
Ethics approval
Institutional review board approval was obtained for this retrospective chart review. The study was performed in accordance with the ethical standards of the Declaration of Helsinki.
Consent to participate
Consent to participate was not required in this study as it was a retrospective chart review. All data analysis was performed in a de-identified fashion.
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Consent for publication was not required in this study as it was a retrospective chart review.
Availability of data and material
The dataset generated and analyzed during the current study is available from the corresponding author on reasonable request.
Code availability
The code utilized for analysis of the current study is available from the corresponding author on reasonable request.
Author contributions
SH contributed to the conceptualization of this study, the methodology and investigation, formal analysis, and drafting and editing of the manuscript. SN contributed to the conceptualization and investigation of the study and to manuscript review and editing. PM contributed to formal analysis and interpretation of data and to manuscript review and editing. RR contributed to the conceptualization of this study, the methodology and investigation, supervision and oversight of the study, and to manuscript review and editing. All authors revised and approved the final version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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Hirsch, S., Nurko, S., Mitchell, P. et al. Prucalopride for Treatment of Upper Gastrointestinal Symptoms in Children. Pediatr Drugs 24, 73–81 (2022). https://doi.org/10.1007/s40272-021-00489-5
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DOI: https://doi.org/10.1007/s40272-021-00489-5