Marcello Maida, MD1, Fabio Salvatore Macaluso, MD2, Emanuele Sinagra, MD3, Marco Ventimiglia, MSCI2
1S. Elia-Raimondi Hospital, Caltanissetta, Sicilia, Italy; 2Villa Sofia-Cervello Hospital, Palermo, Sicilia, Italy; 3Fondazione Istituto San Raffaele Giglio, Cefalù, Sicilia, Italy
Introduction: The efficacy of bowel cleansing is essential for a quality colonoscopy, especially in the setting of colorectal cancer screening. Unfortunately, suboptimal bowel preparation is still observed in 25% of procedures. Recently, a very low-volume 1L PEG solution (NER1006) has been introduced on the evidence of three phase 3 randomized controlled trials. We conducted a meta-analysis to explore cleansing success, adenoma detection rate (ADR), and safety profile of NER1006 versus standard bowel preparations.
Methods: PubMed/Medline and Embase were systematically searched through April 2019 by two independent reviewers (M.M. and F.S.M.) for randomized phase 3 clinical trials comparing the effectiveness of NER1006 versus standard bowel preparations.
Results: Three RCTs (four arms, 2151 participants) met the inclusion criteria and were included in the meta-analysis (Table 1). The analysis showed a significant higher overall cleansing success for patients receiving NER1006 compared with standard preparations both using the Harefield Cleansing Scale (HCS) (OR 1.29; 95% CI 1.02-1.61; p=0.031, I2=0%, 2151 participants) and the Boston Bowel Preparation Scale (BBPS) (OR 1.43; 95% CI 1.15-1.78; p=0.001, I2=0%, 2151 participants) (Figure 1a, 1b), as well as a significant greater high-quality cleansing of the right colon both when assessed with the HCS (OR 2.26; 95% CI 1.44-3.54; p< 0.001, I2=70%, 2151 participants) and with the BBPS (OR 1.74; 95% CI 1.09-2.79; p=0.021, I2=66%, 2151 participants) (Figure 1c, 1d). The pooled estimate of the NER1006 effect on ADR showed no significant difference in terms of overall ADR (OR 1.03; 95% CI 0.85-1.24; p=0.773, I2=0%, 2151 participants), and a higher, although not significant, ADR of the right colon (OR 1.24; 95% CI 0.85-1.79; p=0.262, I2=38%,2151 participants)(Figure 2a, 2b). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of number of TEAEs (OR 2.25; 95% CI 1.81-2.80; p< 0.001, I2=0%, 2060 participants) and of patients with TEAEs (OR 1.80; 95% CI 1.36-2.38; p< 0.001, I2=0%, 2060 participants) (Figure 2c, 2d). No serious adverse events occurred.
Discussion: Compared with standard bowel preparations, NER1006 showed a higher overall cleansing success, a greater high-quality cleansing of the right colon and a higher, although not significant, ADR of the right colon. NER1006 showed a higher incidence of mild to moderate TEAEs, in the absence of serious adverse events.
Citation: Marcello Maida, MD; Fabio Salvatore Macaluso, MD; Emanuele Sinagra, MD; Marco Ventimiglia, MSCI. P0123 - EFFICACY AND SAFETY OF NER1006 VERSUS STANDARD BOWEL PREPARATIONS: A META-ANALYSIS OF RANDOMIZED PHASE 3 CLINICAL TRIALS. Program No. P0123. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.