Abstract
Background and study aims Effective bowel cleansing is critical
for detecting lesions during colonoscopy, highlighting the importance of bowel preparations.
1L polyethylene glycol (PEG) + ...ascorbate (Asc) is the only recommended 1L PEG product in
Europe and the United States. Its efficacy was demonstrated in large-scale controlled trials
and confirmed in smaller-scale real-world studies. However, no large-scale real-world data
exist.
Patients and methods This observational, retrospective,
multicenter study, used outpatient follow-up data from medical records from 10 centers in
Spain and two in Portugal. Outpatients aged ≥18 years using 1L PEG + Asc as bowel preparation
were included. The main outcome measures were overall adequate colon cleansing (Boston Bowel
Preparation Scale BBPS score ≥6 with BBPS score ≥2 in each segment) and high-quality
cleansing of the right colon (BBPS score=3).
Results Data from 13169 eligible patients were included. Overall
cleansing success was achieved in 89.3% (95%CI 88.7%-89.8%) and high-quality cleansing in the
right colon in 49.3% (95%CI 48.4%–50.2%) of patients. For the overnight split-dose and
same-day regimens, overall adequate quality cleansing success rate was 94.7% and 86.7% (P<0.0001) and high-quality cleansing of the right colon rate was
65.4% and 41.4% (P<0.0001), respectively. Colonoscopy was
completed in 97.3% of patients, with non-completion due to poor preparation in only 0.8%; 2.3%
of patients experienced at least one adverse event (AE).
Conclusions This large-scale, real-world study demonstrates the
effectiveness of 1L PEG + Asc in the total and right colon, with a low percentage of patients
with AEs in routine clinical practice.
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.
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.
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.
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.
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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