P3657 - One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality
David Poppers, MD, PhD1, Brooks D. Cash, MD, FACG2, David Bloom, 3, Christopher Allen, MS3, Prateek Sharma, MD4 1NYU Langone Health, New York, NY; 2The University of Texas Health Science Center at Houston, Houston, TX; 3Salix Pharmaceuticals, Bridgewater, NJ; 4University of Kansas School of Medicine and VAMC, Kansas City, KS
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 female (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 (AE).
Discussion: 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.
Disclosures:
David Poppers: Salix Pharmaceuticals – Consultant, Speakers Bureau.
David Poppers, MD, PhD1, Brooks D. Cash, MD, FACG2, David Bloom, 3, Christopher Allen, MS3, Prateek Sharma, MD4. P3657 - One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.