Abstract
Background and aim
Very low-volume bowel preparation (BP) for colonoscopy with 1-liter polyethylene glycol
plus ascorbate (1L-PEG-Asc) has displayed high tolerability and quality of bowel cleansing.
Concerns have been raised regarding its safety. We aimed to evaluate the incidence
of adverse events (AEs) following BP with 1L-PEG-Asc or 2L-PEG-Asc.
Patients and Methods
From January 2019 to September 2020, data from all consecutive adult outpatients who
underwent colonoscopy in Our Unit were collected. AEs were assessed by reviewing the
clinical and laboratory data of patients who attended the Emergency Department (ED)
of Modena District Hospitals in the 7 days following the colonoscopy, and were classified
as “BP-related” or “BP-unrelated”.
Results
During the study, 4069 (68.03%) and 1912 (31.97%) patients underwent colonoscopy after
taking 2L-PEG-Asc or 1L-PEG-Asc, respectively. Regarding AEs, 77 (1.29%) patients
attended ED, 53 (53/4069, 1.30%) and 24 (24/1912, 1.25%) after taking 2L-PEG-Asc and
1L-PEG-Asc. BP-related AEs were observed in 5 (5/4069, 0.12%) and 4 (4/1912, 0.21%)
patients, respectively. The most frequent BP-related AEs were tachyarrhythmias (6/5981,
0.10%).
Conclusion
The incidence rate of clinically relevant BP-related AEs is extremely low. This strongly
suggests that 1L-PEG-Asc colonoscopy BP is as safe as 2L-PEG-Asc BP in a real-life
clinical setting of unselected patients.
Keywords
Abbreviations:
1 L (one liter), 2 L (two liters), 4 L (four liters), AE (adverse event), Asc (ascorbate), BP (bowel preparation), ED (Emergency Department), GCP (Good Clinical Practice), ICH (International Council for Harmonization), PEG (polyethylene glycol), SD (standard deviation)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Digestive and Liver DiseaseAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Novel 1L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate.Gastrointest Endosc. 2018; 87: 677-687
- Colon cleansing efficacy and safety with 1L NER1006 versus 2L polyethylene glycol + ascorbate: a randomized phase 3 trial.Endoscopy. 2019; 51: 60-72
- Colon cleansing efficacy and safety with 1L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial.Endoscopy. 2019; 51: 73-84
- Hyperosmotic low-volume bowel preparations: is NER1006 safe?.Gastrointest Endosc. 2019; 89: 656-658
- Effectiveness of very low-volume preparation for colonoscopy: a prospective, multicenter observational study.World J Gastroenterol. 2020; 26: 1950-1961
https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice
- Safety of NER1006.Gastrointest Endosc. 2019; 90: 540-541
- Effectiveness and safety of NER1006 versus standard bowel preparations: a meta-analysis of randomized phase-3 clinical trials.Dig Liver Dis. 2020; 52: 833-839
- 1L- vs. 4L-Polyethylene glycol for bowel preparation before colonoscopy among inpatients: a propensity score-matching analysis.Dig Liver Dis. 2020; 52: 1486-1493
Article info
Publication history
Published online: May 22, 2022
Accepted:
April 21,
2022
Received:
December 27,
2021
Footnotes
Disclosure: The following authors disclosed financial relationships: A Repici, C Hassan, M Manno: Consultants for Norgine.
Identification
Copyright
© 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
