P0456 (S0237). - One Liter Polyethylene Glycol-Based NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients With or Without Diabetes Mellitus: A Pooled Analysis of 2 Randomized, Phase 3 Studies
Chief-Gastroenterology Section John D. Dingell VA Medical Center Detroit, Michigan
Philip S. Schoenfeld, MD, MSEd, MSc (Epi)1, David M. Poppers, MD, PhD2, Brooks D. Cash, MD, FACG3, Christopher Allen, MS4, Prateek Sharma, MD, FACG5; 1John D. Dingell VA Medical Center, Detroit, MI; 2New York University Langone Medical Center, New York, NY; 3University of Texas Health Science Center, Houston, TX; 4Salix Pharmaceuticals, Bridgewater, NJ; 5Kansas City VA Medical Center, Kansas City, MO
Introduction: Diabetes mellitus (DM) has been found to be an independent risk factor for inadequate bowel preparation for colonoscopy. NER1006, a 1 L polyethylene glycol (PEG)-based bowel preparation, was approved in the US in 2018 for colon cleansing in preparation for colonoscopy in adults. The aim of this study was to compare the efficacy of NER1006 bowel preparation in adults with DM compared with those without DM. Methods: A pooled post hoc analysis was conducted of two phase 3 studies (NOCT and MORA) of adults undergoing colonoscopy randomized to receive evening/morning split-dose regimen of NER1006, excluding those failing to meet entry criteria post-randomization and also not receiving NER1006. 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 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 or 4 [ie, good/excellent]). Good/excellent cleansing quality (colon segments free of stool; score 3 or 4) for each segment using the HCS and overall colon adenoma detection rate (ADR; number of patients with ≥1 adenoma divided by total population) was also determined. P values were calculated using a 2-sided Fisher’s exact test. Results: 47 patients with type 1 DM or type 2 DM (reported as part of medical history) and 504 patients without DM were included. Some numeric differences in demographics in DM versus non-DM groups were observed (eg, male, 55.3% vs 45.4%; mean age, 63.6 y vs 56.4 y; weight, 89.7 kg vs 80.3 kg). There was no significant difference in the NER1006 overall colon cleansing success rate in patients with DM compared with those without DM using the BBPS (78.7% vs 87.3%; P=0.12) or HCS (78.7% vs 89.5%; P=0.05). Good/excellent cleansing quality in each colonic segment was achieved in a similar percentage of patients with DM or without DM (Figure). The overall ADR was significantly higher in patients with DM (51.1%) versus patients without DM (28.2%; P=0.002), but ADR was comparable for the ascending colon (19.1% vs 12.3%; P=0.18). Limitations include the small number of patients and lack of stratification by type of DM. Discussion: These data support that 1 L PEG-based NER1006 is efficacious as a bowel preparation in adults with DM undergoing colonoscopy.
Disclosures: Philip Schoenfeld: AbbVie Inc. – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Ironwood Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Salix Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker's Bureau. David Poppers: Ambu Inc. – Consultant. Olympus Inc. – Consultant. Salix Pharmaceuticals – Consultant. Brooks Cash: Salix Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Christopher Allen: Salix Pharmaceuticals – Employee. Prateek Sharma: Boston Scientific – Consultant. Olympus Inc. – Consultant.