Alessandro Repici1, Emmanuel Coron2, Prateek Sharma3, Cristiano Spada4, Milena Di Leo1, Colin L Noble5, Jürgen Gschossmann6, Ana Bargalló García7, Daniel C Baumgart8. 1. Humanitas University, Milan, Italy. 2. Centre Hospitalier Universitaire Hotel Dieu, Nantes, France. 3. Department of Gastroenterology and Hepatology, Veterans Affairs Medical Center, Kansas City, MO, USA; Department of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, KS, USA. 4. Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. 5. Western General Hospital, Edinburgh, UK. 6. Klinikum Forchheim, Forchheim, Germany. 7. Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain; Endos Medicina, Barcelona, Spain. 8. Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada. Electronic address: baumgart@ualberta.ca.
Abstract
BACKGROUND & AIMS: Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. METHODS: Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed. RESULTS:Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%). CONCLUSION: When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
RCT Entities:
BACKGROUND & AIMS: Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. METHODS:Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed. RESULTS: Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%). CONCLUSION: When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
Authors: Jonathan Manning; Juha Halonen; Sandra Jose Cheriyamkunnel; Marco Antonio Álvarez-González Journal: BMC Gastroenterol Date: 2022-01-25 Impact factor: 3.067