Dan and Lillie Sterling Professor of Medicine; Chief, Division of Gastroenterology, Hepatology, and Nutrition University of Texas Health Science Center Houston, TX
Brooks D. Cash, MD, FACG1, Philip S. Schoenfeld, MD, MSEd, MSc (Epi)2, Sravanthi Parasa, MD3, Christopher Allen, MS4, Prateek Sharma, MD, FACG5; 1University of Texas Health Science Center, Houston, TX; 2John D. Dingell VA Medical Center, Detroit, MI; 3Swedish Medical Group, Seattle, WA; 4Salix Pharmaceuticals, Bridgewater, NJ; 5Kansas City VA Medical Center, Kansas City, MO
Introduction: NER1006 is a 1 L polyethylene glycol (PEG)–based bowel preparation approved in the US in 2018 for colon cleansing in preparation for colonoscopy in adults. Diabetes mellitus is an independent risk factor for inadequate bowel preparation, and GI-related complications (eg, transit time) can impact incidence of adverse events (AEs) with bowel preparations. The current objective was to evaluate the safety profile of NER1006 bowel preparation in adults with diabetes versus those without diabetes. Methods: A pooled post hoc analysis was conducted of two phase 3 studies (NOCT and MORA) of adults undergoing colonoscopy randomized to receive an evening/morning split-dose regimen of NER1006. Diabetes (type 1 or type 2) was determined as part of medical history at screening. Treatment-emergent AEs and clinical laboratory test results were used to evaluate safety through 7 ± 1 days post-colonoscopy. Results: A total of 524 patients were included in the safety analysis (46.4% male; 77.5% aged ≤ 65 y; 82.1% underwent screening/surveillance colonoscopy). Of these, 42 (8.0%) of patients had diabetes and 482 (92.0%) did not have diabetes. No patients discontinued from the study due to an AE. No AEs were reported by >1 patient with diabetes. In the non-diabetes group, the most common AEs were nausea (6.6%) and vomiting (5.6%; Table). One patient in the diabetes group experienced a serious AE, moderate ileus, which was not considered by the investigator to be related to the study drug. Discussion: These data support that 1 L PEG-based NER1006 bowel preparation is safe in adults with or without diabetes undergoing colonoscopy.
Disclosures: Brooks Cash: Salix Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Philip Schoenfeld: AbbVie Inc. – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Ironwood Pharmaceuticals, Inc. – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Salix Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Sravanthi Parasa indicated no relevant financial relationships. Christopher Allen: Salix Pharmaceuticals – Employee. Prateek Sharma: Boston Scientific – Consultant. Olympus Inc. – Consultant.