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©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
Lessons from “real life experience” of rifaximin use in the management of recurrent hepatic encephalopathy
Fiona Chautant, Maeva Guillaume, Marie-Angèle Robic, Jean-François Cadranel, Jean-Marie Peron, Hortensia Lison, Charlène Cool, Christophe Bureau, Véronique Duhalde
Fiona Chautant, Service Pharmacie, Centre Hospitalier Universitaire de Toulouse, Hôpital Paule de Viguier, Toulouse 31059, France
Maeva Guillaume, Marie-Angèle Robic, Jean-Marie Peron, Christophe Bureau, Department of Hepato-Gastroenterology, University Hospital, Toulouse 31059, France
Jean-François Cadranel, Hortensia Lison, Department of Hepato-Gastroenterology, Laennec Hospital, Creil 60109, France
Charlène Cool, Department of Pharmacy and UMR INSERM 1027, University Hospital, Toulouse 31059, France
Véronique Duhalde, Department of Pharmacy, University Hospital Toulouse, Toulouse 31059, France
Author contributions: Chautant F was the guarantor of the article; Chautant F, Bureau C and Duhalde V designed the research study; all authors were involved with data collection or analysis; all authors were involved with data interpretation, drafting or offering critical revisions; Bureau C and Chautant F performed statistical analyses; all authors have read and approved the final manuscript.
Institutional review board statement: As a retrospective study, the approval of the ethics committee was not mandatory (i.e., according to the Jardé Law in France).
Informed consent statement: Informed consent was not required for this study. The data were collected anonymously.
Conflict-of-interest statement: Bureau C and Cadranel JF have conflicts of interest with Alpha Wassermann as speakers at a symposium and Norgine as consultants. The remaining authors disclose no conflict.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Fiona Chautant, PhD, Pharmacist, Department of Pharmacy, University Hospital, 330 avenue de Grande Bretagne, Toulouse 31059, France. fiona.chautant@gmail.com
Received: July 1, 2019
Peer-review started: July 1, 2019
First decision: August 7, 2019
Revised: September 30, 2019
Accepted: December 8, 2019
Article in press: December 8, 2019
Published online: January 27, 2020
Processing time: 186 Days and 11.3 Hours
ARTICLE HIGHLIGHTS
Research background
Hepatic encephalopathy (HE) is a major complication of cirrhosis with independant prognostic significance. The clinical and economic burdens of HE is tremendous and growing worldwide. Therapies are needed to improve the quality of life of patients and to decrease the rate of hospitalizations and the economic consequences.
Research motivation
The current management of HE is mainly based on lactulose. Rifaximin has been shown to decrease the risk of HE recurrence in patients with episodic forms. HE can also be persistent. However, there is no drug support recommendation for rifaximin use in this setting.
Research objections
The study aimed at assessing the effectiveness of rifaximin in the management of recurrent episodes of HE and recurrent acute exacerbations on persistent HE, in “real life conditions”.
Research methods
This is a retrospective study using a within-subjects design. The data of patients treated with rifaximin for HE is collected in two liver diseases centers, during the six-month period before and during the six-month period after the initiation of rifaximin. The primary effectiveness endpoint was the total number of HE events involving hospitalization.
Research results
In the case of patients presenting recurrent episodes of HE, we observed a significantly reduction of the total number of HE-events by up to 50%. Conversely, in the prevention of acute exacerbations in patients with persistent HE, an off-label use which has been found in more than half of the studied population, there was no significant difference in the number of HE-events.
Research conclusions
The effectiveness of rifaximin was confirmed in the prevention of HE episodes recurrence but was not proved in the prevention of acute exacerbations recurrence on persistent HE.
Research perspectives
We noticed some encouraging results with a certain probability of persistent HE cessation. Randomized controlled trials are needed to assess rifaximin efficacy in this type of HE. It seems necessary to develop standardized and reproducible tools to improve the patients’ selection in clinical trials and allow results comparison among studies. It seems to be an essential step to achieve further progress in the management of HE in clinical practice.
