The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial.
Ascites
/ surgery
Double-Blind Method
Female
France
Gastrointestinal Agents
/ therapeutic use
Gastrointestinal Hemorrhage
/ prevention & control
Hepatic Encephalopathy
/ etiology
Humans
Liver Cirrhosis
/ surgery
Male
Middle Aged
Portasystemic Shunt, Transjugular Intrahepatic
Rifaximin
/ therapeutic use
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
pubmed:
2
2
2021
medline:
7
8
2021
entrez:
1
2
2021
Statut:
ppublish
Résumé
The efficacy of rifaximin in the secondary prevention of overt hepatic encephalopathy (HE) is well documented, but its effectiveness in preventing a first episode in patients after transjugular intrahepatic portosystemic shunt (TIPS) has not been established. To determine whether rifaximin prevents overt HE after TIPS compared with placebo. Randomized, double-blind, multicenter, placebo-controlled trial. (ClinicalTrials.gov: NCT02016196). 197 patients with cirrhosis undergoing TIPS for intractable ascites or prevention of variceal rebleeding. Patients were randomly assigned to receive rifaximin (600 mg twice daily) or placebo, beginning 14 days before TIPS and continuing for 168 days after the procedure. The primary efficacy end point was incidence of overt HE within 168 days after the TIPS procedure. An episode of overt HE occurred in 34% (95% CI, 25% to 44%) of patients in the rifaximin group ( The study's conclusion applies mainly to patients with alcoholic cirrhosis, who made up the study population. The potential benefit of rifaximin 6 months after TIPS and beyond remains to be investigated. In patients with cirrhosis treated with TIPS, rifaximin was well tolerated and reduced the risk for overt HE. Rifaximin should therefore be considered for prophylaxis of post-TIPS HE. French Public Health Ministry.
Sections du résumé
BACKGROUND
The efficacy of rifaximin in the secondary prevention of overt hepatic encephalopathy (HE) is well documented, but its effectiveness in preventing a first episode in patients after transjugular intrahepatic portosystemic shunt (TIPS) has not been established.
OBJECTIVE
To determine whether rifaximin prevents overt HE after TIPS compared with placebo.
DESIGN
Randomized, double-blind, multicenter, placebo-controlled trial. (ClinicalTrials.gov: NCT02016196).
PARTICIPANTS
197 patients with cirrhosis undergoing TIPS for intractable ascites or prevention of variceal rebleeding.
INTERVENTION
Patients were randomly assigned to receive rifaximin (600 mg twice daily) or placebo, beginning 14 days before TIPS and continuing for 168 days after the procedure.
MEASUREMENTS
The primary efficacy end point was incidence of overt HE within 168 days after the TIPS procedure.
RESULTS
An episode of overt HE occurred in 34% (95% CI, 25% to 44%) of patients in the rifaximin group (
LIMITATIONS
The study's conclusion applies mainly to patients with alcoholic cirrhosis, who made up the study population. The potential benefit of rifaximin 6 months after TIPS and beyond remains to be investigated.
CONCLUSION
In patients with cirrhosis treated with TIPS, rifaximin was well tolerated and reduced the risk for overt HE. Rifaximin should therefore be considered for prophylaxis of post-TIPS HE.
PRIMARY FUNDING SOURCE
French Public Health Ministry.
Substances chimiques
Gastrointestinal Agents
0
Rifaximin
L36O5T016N
Banques de données
ClinicalTrials.gov
['NCT02016196']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
633-640Commentaires et corrections
Type : CommentIn