S360 One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality

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Introduction: A high-quality tolerable bowel prep is a critical component of successful colonoscopy. Patient-specific factors, such as medication use (eg, opioids, tricyclic antidepressants [TCAs]), can negatively impact bowel prep quality. The current aim was to evaluate the efficacy of the 1L bowel prep NER1006 vs a 2L polyethylene glycol plus ascorbate solution (2L PEG) in patients stratified by use of concomitant medications that can adversely impact bowel prep quality. Methods: A pooled post hoc analysis was conducted of 2 phase 3 noninferiority trials (NOCT/MORA) of adults undergoing colonoscopy who were randomized to an eve/morning split-dose regimen of NER1006 (NOCT/MORA) or 2L PEG (MORA). Patients with concomitant use of opioids and/or TCAs were included in the analysis. Overall colon cleansing success rates were assessed using the Boston Bowel Preparation Scale (BBPS; success defined as overall score ≥ 6, with score ≥ 2 in each segment [right, transverse, and left colon]) or Harefield Cleansing Scale (HCS; success defined as all 5 colonic segments (ascending/transverse/descending/sigmoid/rectum) scored 3 [clear liquid] or 4 [empty and clean] or ≥ 1 segment scored 2 [brown liquid/fully removable semi-solid stools] and other segments scored 3-4 [ie, good/excellent]). Good/excellent cleansing quality for each segment (free of stool; score 3-4) using the HCS was also determined. P values were calculated using a Chi-square test. Results: 139 patients were included with a difference in sample sizes observed (NER1006 [n = 113] vs 2L PEG [n = 26]). About half were women (53.1% vs 57.7%), and the mean age was 55.7 y vs 54.6 y (overall range, 18-84 y). NER1006 and 2L PEG had a similar high overall colon cleansing success rate using the BBPS (88.5% vs 84.6%, respectively; P = 0.59) or the HCS (92.0% vs 88.5%; P = 0.56). Good/excellent cleansing quality using HCS in each colonic segment was numerically higher for NER1006 vs 2L PEG, but differences were not significant, except for the rectum: ascending (32.7% vs 23.1%; P = 0.34); transverse (40.7% vs 30.8%; P = 0.35); descending (39.8% vs 26.9%; P = 0.22); sigmoid (52.2% vs 38.5%; P = 0.21); and rectum (75.2% vs 53.8%; P = 0.03). Both preps were well tolerated, and no patients failed to complete the bowel prep due to an adverse event. Conclusion: 1L NER1006 was as effective as the higher-volume 2L PEG bowel prep in adults undergoing colonoscopy and receiving concomitant opioids and/or TCAs that are known to potentially impact bowel prep quality.

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