Endoscopy 2022; 54(S 01): S145-S146
DOI: 10.1055/s-0042-1744952
Abstracts | ESGE Days 2022
ESGE Days 2022 Digital poster exhibition

1 LITER PEG+ASC BOWEL PREPARATION NER1006 IS AN INDEPENDENT PREDICTOR OF ADEQUATE AND HIGH-QUALITY CLEANSING SUCCESS: A POOLED ANALYSIS OF 2 RANDOMIZED PHASE 3 TRIALS

M. Epstein
1   Investigative Clinical Research, Annapolis, United States
,
E. Shah
2   Dartmouth-Hitchcock Health, Lebanon, United States
,
C. Allen
3   Salix Pharmaceuticals, Bridgewater, United States
,
R. Bisschops
4   University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium
› Author Affiliations
 

Aims Adequacy of bowel preparation for colonoscopy is critical for maximizing the therapeutic benefits of colonoscopy. High-quality cleansing has been shown to improve adenoma detection rates for individual patients. This analysis aimed to use optimized regression models to elucidate predictors of both adequate and high-quality colon cleansing success.

Methods A pooled post hoc analysis of two published phase 3 trials was conducted; included in the study were adults randomly assigned to receive the 1L polyethylene glycol (PEG)–based bowel prep NER1006, oral sulfate solution, or 2L PEG plus ascorbate solution, administered as an evening/morning split-dose regimen (1,2) The Boston Bowel Preparation Scale was used to define overall adequate colon cleansing success (total score≥6, with a score≥2 in each of 3 colonic segments) and overall high-quality colon cleansing success (total score 7-9, with a score of≥2 for each segment). Multivariate logistic regression was performed, and odds ratios with 95% confidence intervals were determined.

Results The overall population included 1018 patients (50.3% male; NER1006 treatment, n=510; comparator, n=508). Four variables were significantly associated with the achievement of overall adequate cleansing success: age, time lapse, participation in the NOCT trial, and NER1006 use. Two variables were significantly associated with achievement of overall high-quality colon cleansing success: time lapse and NER1006 use (Table 1).

Table 1 Linear Regression and Odds Ratio Analysis to Identify Variables Impacting High-Quality Colon Cleansing Success [1]

High-Quality Colon Cleansing

Dependent Variable

Regression Coefficient (SE)

OR (95% CI)

P-value

NER1006 use

0.28 (0.14)

1.32 (1.01, 1.73)

0.04

Time lapse, h

-0.09 (0.04)

0.92 (0.85, 0.99)

0.02

∗ Boston Bowel Preparation Scale total score . 6, with score . 2 in each of 3 colonic segments. OR = odds ratio.


Conclusions NER1006 was the only independent, positive predictor of both adequate and high-quality colon cleansing success in patients undergoing colonoscopy.



Publication History

Article published online:
14 April 2022

© 2022. European Society of Gastrointestinal Endoscopy. All rights reserved.

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  • References

  • 1 Bisschops R, et al. Endoscopy. 2019;51(1):60-72.
  • 2 DeMicco M, et al. Gastrointest Endosc. 2018;87(3):677-687.