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


Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
08 2020
Historique:
received: 14 05 2020
revised: 19 05 2020
accepted: 26 05 2020
pubmed: 27 6 2020
medline: 15 7 2021
entrez: 27 6 2020
Statut: ppublish

Résumé

A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed. We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations. PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations. 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 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.

Sections du résumé

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
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.

Identifiants

pubmed: 32586765
pii: S1590-8658(20)30252-8
doi: 10.1016/j.dld.2020.05.046
pii:
doi:

Substances chimiques

Cathartics 0
Polyethylene Glycols 3WJQ0SDW1A
Ascorbic Acid PQ6CK8PD0R

Types de publication

Comparative Study Journal Article Meta-Analysis Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

833-839

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest The authors have no proprietary, financial, professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of this manuscript.

Auteurs

M Maida (M)

Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy. Electronic address: marcello.maida@hotmail.it.

F S Macaluso (FS)

IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.

S Sferrazza (S)

Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy.

M Ventimiglia (M)

IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.

E Sinagra (E)

Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy.

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Classifications MeSH