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Safety and Effectiveness of Prucalopride in Children with Functional Constipation with and without Upper Symptoms

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Abstract

Introduction

Pediatric prucalopride studies for treatment of gastrointestinal (GI) disorders have reported mixed results. We aimed to assess the safety and effectiveness of prucalopride in functional constipation (FC) with and without upper GI symptoms.

Methods

Retrospective data on patients with FC receiving combined prucalopride and conventional therapy was compared with those receiving conventional therapy alone within 12 months. Thirty patients on combined therapy and those on conventional therapy were each matched on the basis of age, gender, race, and presence of fecal soiling. Response (complete, partial, or no resolution) was compared. Similarly, response to concurrent functional upper GI symptoms (postprandial pain, bloating, weight loss, vomiting, early satiety, or nausea) and dysphagia, as well as adverse effects, were evaluated in the combined group.

Results

Mean age of 57 cases was 14.7 ± 4.9 years and 68% were female. Comorbidities included functional upper GI (UGI) symptoms (84%), dysphagia (12%), mood disorders (49%), and hypermobility spectrum disorder (37%). Unmatched cases reported 63% improvement to FC; response did not differ between the matched cohorts (70% versus 76.6%, p = 0.84). Cases showed a 56% improvement in functional UGI symptoms and 100% in dysphagia. Adverse effects were reported in 30%, abdominal cramps being most common. Four (7%) patients with a known mood disorder reported worsened mood, of which two endorsed suicidal ideation.

Conclusion

Prucalopride efficaciously treated concurrent UGI symptoms and dysphagia in constipated pediatric patients and was overall well tolerated. Preexisting mood disorders seemed to worsen in a small subset of cases.

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Acknowledgements

We would like to thank Jennifer Hardy for data parsing.

Author information

Authors and Affiliations

  1. Gastroenterology, Hepatology and Nutrition, Pediatric Gastroenterology, Cincinnati Children’s Hospital Medical Center, Suite T8.382, 3333 Burnet Ave, Cincinnati, OH, 45229, USA

    Alejandro Velez, Ajay Kaul, Khalil I. El-Chammas, Lesley Knowlton, Erick Madis & Neha R. Santucci

  2. University of Cincinnati College of Medicine, Cincinnati, OH, USA

    Ajay Kaul, Khalil I. El-Chammas & Neha R. Santucci

  3. Biostatistics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

    Rashmi Sahay & Lin Fei

  4. Division of Pharmacy, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

    Sarah Stiehl

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  1. Alejandro Velez
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Corresponding author

Correspondence to Neha R. Santucci.

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Funding

This study was funded by pediatric gastroenterology divisional funds.

Conflict of Interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.

Ethics Approval

This retrospective chart review study involving human participants was done in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Human Investigation Committee (IRB) of the Cincinnati Children’s Hospital approved this study.

Informed Consent

Not applicable.

Consent for Publication

Not applicable.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author Contribution Statement

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Lesley Knowlton, Erick Madis, and Alejandro Velez Lopez supervised by Dr. Neha R Santucci. Dr. Rashmi Sahay provided statistical expertise, Sarah Stiehl provided pharmaceutical expertise, while Drs. Kaul, El-Chammas and Santucci provided expertise on functional constipation and other motility disorders. The first draft of the manuscript was written by Alejandro Velez Lopez and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Previous Communications:

As an abstract/poster for the 2021 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) that only included the prucalopride cohort results. As an abstract/poster for NASPGHAN 2022 that included the conventional therapy–prucalopride cohort analysis and the propensity matched data. As an abstract/podium presentation for 2022 Pediatric Colorectal and Pelvic Reconstruction Conference (PCPLC).

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Velez, A., Kaul, A., El-Chammas, K.I. et al. Safety and Effectiveness of Prucalopride in Children with Functional Constipation with and without Upper Symptoms. Pediatr Drugs 26, 187–195 (2024). https://doi.org/10.1007/s40272-023-00612-8

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  • DOI: https://doi.org/10.1007/s40272-023-00612-8

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