Rifaximin Treatment in Hepatic Encephalopathy
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<0.001). A breakthrough episode of hepatic encephalopathy occurred in 22.1% of patients in the rifaximin group, as compared with 45.9% of patients in the placebo group. A total of 13.6% of the patients in the rifaximin group had a hospitalization involving hepatic encephalopathy, as compared with 22.6% of patients in the placebo group, for a hazard ratio of 0.50 (95% CI, 0.29 to 0.87; P=0.01). More than 90% of patients received concomitant lactulose therapy. The incidence of adverse events reported during the study was similar in the two groups, as was the incidence of serious adverse events. 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.)
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Rifaximin improves HE, reduces hospital admission rates due to HE and the incidence of recurrent HE.
“Rifaximin is a non-absorbable antibiotic that improves HE, reduces hospital admission rates due to HE and the incidence of recurrent HE.243–245”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [243]
Targeting the gut-microbiota-liver axis reduces spontaneous bacterial peritonitis and hepatic encephalopathy in patients.
“and spontaneous bacterial peritonitis98 and hepatic encephalopathy99 in patients.”
From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [99]
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- Authors
- Bass, N. M., Mullen, K. D., Sanyal, A., Poordad, F., Neff, G., Leevy, C. B., Sigal, S., Sheikh, M. Y., Beavers, K., Frederick, T., Teperman, L., Hillebrand, D., Huang, S., Merchant, K., Shaw, A., Bortey, E., & Forbes, W. P.
- Affiliations
- University of California, San Francisco (US)
- MetroHealth Medical Center (US)
- Virginia Commonwealth University (US)
- Cedars-Sinai Medical Center (US)
- University of Cincinnati Medical Center (US)
- University of Medicine and Dentistry of New Jersey (US)
- Cornell University (US)
- New York University (US)
- Salix Pharmaceuticals (United States) (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-03-25
- Volume
- 362
- Issue
- 12
- Pages
- 1071-1081
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2099360240
- Cited by
- 1,300
- References
- 0
- Citations by year
- 2026: 58 · 2025: 73 · 2024: 74 · 2023: 75 · 2022: 77 · 2021: 90 · 2020: 75 · 2019: 76 · 2018: 88 · 2017: 76 · 2016: 81 · 2015: 89 · 2014: 90 · 2013: 82 · 2012: 80
- FWCI
- 57.30
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- VCU Scholars Compass (Virginia Commonwealth University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Health Sciences › Medicine › Surgery › Abdominal vascular conditions and treatments
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Keywords
- rifaximin, hepatic encephalopathy, liver cirrhosis, chronic liver disease, antibiotic therapy, lactulose, hospitalization risk, remission maintenance
- MeSH terms
- Rifaximin, Aged, Anti-Infective Agents, Chronic Disease, Clostridium Infections, Double-Blind Method, Drug Therapy, Combination, Female, Gastrointestinal Agents, Hepatic Encephalopathy, Hospitalization, Humans, Lactulose, Liver Cirrhosis, Male, Middle Aged, Rifamycins, Proportional Hazards Models, Clostridioides difficile, Kaplan-Meier Estimate, Secondary Prevention, Intention to Treat Analysis
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