36 - One-Liter Polyethylene Glycol + Ascorbic Acid Bowel Preparation Delivers High Levels of Adequate and High-Quality Bowel Cleansing for Colonoscopy: A Real-World, Multicenter, Observational Study of Over 13,000 Patients
Cátia Arieira, MD1, José Cotter, MD1, Ricardo Gorjão, MD2, Vicente Lorenzo-Zúñiga, MD3, Miguel A. Pantaleón Sánchez, MD4, David Carral Martínez, MD5, Fernándo Sábado, MD6, Elena Pérez Arellano, MD7, Blas J. Gómez Rodríguez, MD8, Antonio López Cano, MD9, Salvador Machlab, MD10, Jose M. Esteban López-Jamar, MD11, Elena Velasco, MD11, Sarbelio Rodriguez, MD12, Juha Halonen, PhD13, Fatma Akriche, MD13, Carmen Turbí Disla, MD14 1Hospital da Senhora da Oliveira, Guimarães, Braga, Portugal; 2Hospital CUF Descobertas, Lisbon, Lisboa, Portugal; 3Hospital HM Sant Jordi, Barcelona, Catalonia, Spain; 4Hospital del Mar, Barcelona, Catalonia, Spain; 5Hospital San Rafael, A Coruña, Galicia, Spain; 6Consorcio Hospitalario Provincial de Castelló, Valencia, Comunidad Valenciana, Spain; 7Hospital La Zarzuela, Madrid, Madrid, Spain; 8Hospital Quirón Salud Sagrado Corazón, Sevilla, Andalucia, Spain; 9Hospital Doctor López Cano, Cádiz, Andalucia, Spain; 10Parc Taulı́ Hospital Universitari & Institut d’Investigació i Innovació Parc Taulı́ I3PT, Sabadell, Catalonia, Spain; 11Hospital Universitario Clínico San Carlos, Madrid, Madrid, Spain; 12Hospital Ruber Juan Bravo, European University of Madrid, Madrid, Madrid, Spain; 13Norgine, Medical Affairs, Harefield, England, United Kingdom; 14Norgine, Madrid, Madrid, Spain
Introduction: 1L polyethylene glycol + ascorbic acid preparation (1L PEG+ASC) has shown high bowel cleansing efficacy in clinical trials. Here we report the largest real-world study on 1L PEG+ASC effectiveness to date.
Methods: An observational, multicenter, retrospective study evaluated outpatients who underwent a colonoscopy between July 2019 and September 2021 at 12 centers in Spain and Portugal. Adults (aged ≥18 years) who had a screening, surveillance, or diagnostic colonoscopy after 1L PEG+ASC as an evening/morning (split dose) or same-day regimen were included. Bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS). Adequate cleansing success was defined as a total BBPS score ≥6 with all segmental scores ≥2. Segmental BBPS scores of 3 defined high-quality cleansing. Safety was assessed through registered adverse events (AEs). Cleansing rates between subgroups were compared with the Chi-square test and BBPS scores with the Wilcoxon rank-sum test.
Results: A total of 13,169 patients were included; 48.6% of patients were male, mean (SD) age was 57.0 ± 13.1 years. The main colonoscopy indication was screening (41.9%), followed by diagnostic (29.4%). Most patients (67.2%) received a same-day dosing regimen. Overall cleansing success was achieved in 89.3% (95% CI: 88.7%–89.8%) of patients. High-quality cleansing of the right colon was attained in 49.3% of patients (95% CI: 48.4%–50.2%). The split-dose regimen attained superior adequate colon cleansing success versus the same-day regimen (94.7% vs. 86.7%; P < 0.0001) and superior high-quality cleansing of the right colon (65.4% vs. 41.4%; P < 0.0001). Rates of adequate bowel cleansing per segment were high for all regimens (Figure 1A). Overall and segmental BBPS scores were significantly greater with the split-dose versus same-day regimen (Figure 1B). Effect of time to colonoscopy on mean overall BBPS score was statistically significant in patients receiving same-day dosing (Figure 1C). Colonoscopy was completed in 97.3% of patients; only 0.8% of procedures were incomplete due to poor preparation. The incidence of AEs was 2.3% (95% CI: 2.0%–2.5%); the main AEs were nausea (1.2%), vomiting (0.8%), and abdominal pain (0.2%).
Discussion: Results from this large study confirm the high cleansing effectiveness and good tolerability of 1L PEG+ASC in real-world settings.
Figure: Figure 1. Bowel cleansing performance of 1L PEG+ASC: (A) Rates of segmental-level adequate-cleansing (BBPS score ≥2); (B) Mean BBPS score for the overall colon and per colon segment; (C) Effect of time to colonoscopy on mean BBPS score in patients receiving same-day or split dose regimens.
Disclosures:
Cátia Arieira indicated no relevant financial relationships.
José Cotter indicated no relevant financial relationships.
Ricardo Gorjão indicated no relevant financial relationships.
Vicente Lorenzo-Zúñiga indicated no relevant financial relationships.
Miguel Pantaleón Sánchez indicated no relevant financial relationships.
David Carral Martínez indicated no relevant financial relationships.
Fernándo Sábado indicated no relevant financial relationships.
Elena Pérez Arellano: Norgine – Honoraria for speaking.
Blas J. Gómez Rodríguez indicated no relevant financial relationships.
Antonio López Cano indicated no relevant financial relationships.
Salvador Machlab indicated no relevant financial relationships.
Jose M. Esteban López-Jamar indicated no relevant financial relationships.
Elena Velasco indicated no relevant financial relationships.
Sarbelio Rodriguez: Norgine – Honoraria for speaking.
Juha Halonen: Norgine – Employee.
Fatma Akriche: Norgine – Employee.
Carmen Turbí Disla: Norgine – Employee.
Cátia Arieira, MD1, José Cotter, MD1, Ricardo Gorjão, MD2, Vicente Lorenzo-Zúñiga, MD3, Miguel A. Pantaleón Sánchez, MD4, David Carral Martínez, MD5, Fernándo Sábado, MD6, Elena Pérez Arellano, MD7, Blas J. Gómez Rodríguez, MD8, Antonio López Cano, MD9, Salvador Machlab, MD10, Jose M. Esteban López-Jamar, MD11, Elena Velasco, MD11, Sarbelio Rodriguez, MD12, Juha Halonen, PhD13, Fatma Akriche, MD13, Carmen Turbí Disla, MD14, 36, One-Liter Polyethylene Glycol + Ascorbic Acid Bowel Preparation Delivers High Levels of Adequate and High-Quality Bowel Cleansing for Colonoscopy: A Real-World, Multicenter, Observational Study of Over 13,000 Patients, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.