Effectiveness and safety of NER1006 versus standard bowel preparations: A meta-analysis of randomized phase-3 clinical trials

Background: A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed.Aims: We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations.Methods: PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations.Results: Three RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00-1.62; p = 0.047, I-2= 0%) as well as a greater high-quality cleansing of the right colon (OR= 2.13; 95% CI 1.16-3.94; p = 0.015, I-2= 76.0%) when assessed by the Harefield Cleansing Scale (HCS).The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR= 1.19; 95% CI 0.73-1.92; p = 0.485, I-2 = 53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR= 2.31; 95% CI 1.82-2.94; p<0.001, I-2 = 0%).Conclusions: When compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events. (c) 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.