Comparative assessment of bowel cleansing of 1 l polyethylene glycol plus ascorbate NER1006 compared with 2 l polyethylene glycol plus ascorbate: A phase 3, randomized, multicenter trial

Background: Many polyethylene glycol (PEG)-based bowel preparations require large volumes for dosing, and research has focused on reducing such volume requirements while maximizing colon cleansing efficacy and tolerability. This post hoc analysis evaluated the efficacy of NER1006, a 1 L PEG plus ascorbate bowel prep, compared with a 2 L PEG plus ascorbate (2 L PEG) bowel prep in adults undergoing colonoscopy. Methods: Patients aged 18-85 y were randomly assigned to receive: 1) an evening/morning split dose of NER1006; 2) morning-only split dose of NER1006 (ie, 2 morning doses); or 3) evening/morning split dose of 2 L PEG. Bowel cleansing efficacy was assessed using the Harefield Cleansing Scale (HCS; score of 0-4 for 5 segments of the colon) or the Boston Bowel Preparation Scale (BBPS; score of 0-3 for 3 segments of the colon, with a maximum overall score of 9). This post hoc analysis included patients who were randomly assigned to treatment who had readable colonoscopy videos for blinded central readers, excluding those who failed screening or had diary confirmation that they did not take any study drug. The Wilcoxon rank-sum test was used to compare treatment groups. Results: A total of 792 patients (NER1006 2-day, nZ262; NER1006 1-day, nZ270; 2 L PEG, nZ260) were included in the current analysis. In the NER1006 2-day, NER1006 1-day, and 2 L PEG groups, the mean ages were 56.6 y, 54.8 y, and 54.3 y, respectively; the percentage of males were 41.2%, 46.3%, and 52.7%. Both NER1006 2-day and 1-day split dosing provided significantly higher (better) mean HCS scores for nearly all 5 segments of the colon versus 2 L PEG, including the ascending colon plus cecum (Figure). Significantly higher (better) mean BBPS scores for the overall colon were observed with NER1006 2-day versus 2 L PEG (6.7 ® 1.2 vs 6.3 ® 1.2; PZ0.0001) and NER1006 1-day versus 2 L PEG (6.6 ® 1.5 vs 6.3 ® 1.2; PZ0.006). Significant differences favoring NER1006 dosing regimens were also observed for the mean BBPS scores for the right colon: 2 L PEG (2.0 ® 0.6) versus NER1006 2-day (2.2 ® 0.5; PZ0.0003 vs 2 L PEG) and NER1006 1-day (2.2 ® 0.6; PZ0.01 vs 2 L PEG). Conclusions: Evening/morning split-dosing and morning-only split-dosing of the low-volume bowel prep NER1006 provided significantly better colon cleansing overall and within various segments of the colon compared with 2 L PEG in adults undergoing colonoscopy. (Figure Presented).