Document Type
Article
Original Publication Date
2010
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
362
DOI of Original Publication
10.1056/NEJMoa0907893
Date of Submission
January 2015
Abstract
Background
Hepatic encephalopathy is a chronically debilitating complication of hepatic cirrhosis. The efficacy of rifaximin, a minimally absorbed antibiotic, is well documented in the treatment of acute hepatic encephalopathy, but its efficacy for prevention of the disease has not been established.
Methods
In this randomized, double-blind, placebo-controlled trial, we randomly assigned 299 patients who were in remission from recurrent hepatic encephalopathy resulting from chronic liver disease to receive either rifaximin, at a dose of 550 mg twice daily (140 patients), or placebo (159 patients) for 6 months. The primary efficacy end point was the time to the first breakthrough episode of hepatic encephalopathy. The key secondary end point was the time to the first hospitalization involving hepatic encephalopathy.
Results
Rifaximin significantly reduced the risk of an episode of hepatic encephalopathy, as compared with placebo, over a 6-month period (hazard ratio with rifaximin, 0.42; 95% confidence interval [CI], 0.28 to 0.64; P
Conclusions
Over a 6-month period, treatment with rifaximin maintained remission from hepatic encephalopathy more effectively than did placebo. Rifaximin treatment also significantly reduced the risk of hospitalization involving hepatic encephalopathy. (ClinicalTrials.gov number, NCT00298038.)
Rights
From The New England Journal of Medicine, Bass, N.M., Mullen, K.D., Sanyal, A. et al., Rifaximin Treatment in Hepatic Encephalopathy, Vol. 362, Page 1071, Copyright © 2010 Massachusetts Medical Society.
Is Part Of
VCU Internal Medicine Publications
Supplementary Appendix
Comments
Originally Published at http://dx.doi.org/10.1056/NEJMoa0907893