Safety of a novel 1L-polyethylene glycol-ascorbate solution for colonoscopy cleansing (REAL Study)

Area of Science:

• Gastroenterology
• Clinical Safety
• Endoscopy Procedures

Background:

• Very low-volume bowel preparation (BP) using 1-liter polyethylene glycol plus ascorbate (1L-PEG-Asc) demonstrates high tolerability and cleansing quality for colonoscopy.
• Concerns regarding the safety of 1L-PEG-Asc have been raised, necessitating a comparative safety evaluation.

Purpose of the Study:

• To evaluate and compare the incidence of adverse events (AEs) following bowel preparation with 1L-PEG-Asc versus 2-liter polyethylene glycol plus ascorbate (2L-PEG-Asc).

Main Methods:

• Retrospective analysis of consecutive adult outpatients undergoing colonoscopy from January 2019 to September 2020.
• Adverse events were assessed by reviewing clinical and laboratory data of patients presenting to the Emergency Department within 7 days post-colonoscopy.
• Adverse events were categorized as either bowel preparation-related or unrelated.

Main Results:

• A total of 6,000+ patients were included, with 1912 receiving 1L-PEG-Asc and 4069 receiving 2L-PEG-Asc.
• The overall incidence of emergency department visits was similar between groups (1.30% for 2L-PEG-Asc vs. 1.25% for 1L-PEG-Asc).
• Clinically relevant bowel preparation-related adverse events were rare, occurring in 0.12% of the 2L-PEG-Asc group and 0.21% of the 1L-PEG-Asc group. Tachyarrhythmias were the most frequent BP-related AE.

Conclusions:

• The incidence of clinically relevant bowel preparation-related adverse events is extremely low for both 1L-PEG-Asc and 2L-PEG-Asc.
• 1L-PEG-Asc bowel preparation is as safe as 2L-PEG-Asc in a real-world clinical setting with unselected patients undergoing colonoscopy.