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Cited by 10Gastrointestinal motility and disordersPharmaceutical studies and practicesPharmacovigilance and Adverse Drug Reactions

The DOI matches its Crossref record; 56 of the 56 references it cites were found in a registry or an index.

Utilisation and Safety of Polyethylene Glycol 3350 With Electrolytes in Children Under 2 Years: A Retrospective Cohort

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Roy, Debabrata, Akriche, Fatma, Amlani, Bharat, Shakir, Saad·2021·Journal of Pediatric Gastroenterology and Nutrition
DOI 10.1097/mpg.0000000000003074PMC PMC8549461
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Abstract

Objectives: In the UK, Movicol paediatric plain (polyethylene glycol 3350 with electrolytes [PEG 3350+E], Norgine, UK), is licensed for chronic constipation in children 2 –11 years of age and faecal impaction (FI) from 5 years. This study aimed to investigate usage and characterise the risk profile in children under 2 years of age using PEG 3350+E in the UK. Methods: Retrospective, single exposure cohort study, with patients identified from Clinical Practice Research Datalink (CPRD) GOLD. Patients first prescribed PEG 3350+E under 2 years of age for the treatment of constipation or FI, between September 2003 and July 2019, were included. Results: There were 13,235 patients with a constipation indication and 40 patients with FI. For the constipation cohort: median age of PEG 3350+E first prescription was 1.2 years [interquartile range (IQR) 0.9, 1.6] and 68.4% had one treatment episode (TE). The mean duration of exposure, in the first TE, was 88.9 days. The most common total daily dose was one sachet (6.9 g). In terms of incident events on treatment, 0.5% of patients had abdominal pain, 3.0% had diarrhoea (may be attributed to treatment) and 4.1% had vomiting. 2.0% had signs/symptoms which could (in extreme cases) be associated with electrolyte disturbance, however, none had abnormal electrolyte values. Discussion: The safety aspect of this study did not identify any signals of concern in the constipation cohort. The number of patients in the FI cohort were too small for robust conclusions. If information were available, then a safety study would ideally assess treatment intake per kilogram, including electrolyte intake, before reaching safety conclusions. Nevertheless, these data contribute to real‐world evidence on the use of PEG 3350+E in this population.

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Research works printed but not linked: 3

  1. Candy D, 2016, MOVICOL® (PEG3350 plus electrolytes): 20 years of evidence‐based use. Key opinions in medicine, Gastroenterology, 3, 1
  2. 10.1002/j.1536-4801.2002.tb07654.x · DOI
  3. Bautista‐Casasnovas A, 2013, Polyethylene glycol with electrolytes in patients younger than 2 years old. Dosage, efficacy and tolerance. Study in 35 patients, Acta Pediatr Esp, 71, 213

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Metadata

Authors
Roy, D., Akriche, F., Amlani, B., & Shakir, S.
Affiliations
  • Drug Safety Research Unit (GB)
  • Norgine Global Medical Affairs Rueil Malmaison France
  • Norgine (United Kingdom) (GB)
Corresponding author
  • Roy, Debabrata
  • Shakir, Saad
ORCID
Venue
Journal of Pediatric Gastroenterology and Nutrition
Publisher
Wiley
Published
2021-02-10
Volume
72
Issue
5
Pages
683-689
ISSN
  • 0277-2116 (ISSN-L)
  • 1536-4801
DOI
10.1097/mpg.0000000000003074
PMC
PMC8549461
OpenAlex
W3129753646
Cited by
10
References
56
Citations by year
2026: 1 · 2025: 3 · 2024: 1 · 2023: 4 · 2022: 1
FWCI
1.37
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Pediatric Gastroenterology and Nutrition (publishedVersion, cc-by-nc-nd)
  • Europe PMC (PubMed Central) (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
Norgine
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
pediatric constipation, fecal impaction, infants under 2 years, drug safety, adverse events, electrolyte imbalance, real-world prescribing patterns, laxative use
MeSH terms
Child, Constipation, Electrolytes, Humans, Infant, Polyethylene Glycols, Retrospective Studies, Cohort Studies, Treatment Outcome

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