Abstract | BACKGROUND: 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:
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Authors | Nathan M Bass, Kevin D Mullen, Arun Sanyal, Fred Poordad, Guy Neff, Carroll B Leevy, Samuel Sigal, Muhammad Y Sheikh, Kimberly Beavers, Todd Frederick, Lewis Teperman, Donald Hillebrand, Shirley Huang, Kunal Merchant, Audrey Shaw, Enoch Bortey, William P Forbes |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 362
Issue 12
Pg. 1071-81
(Mar 25 2010)
ISSN: 1533-4406 [Electronic] United States |
PMID | 20335583
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2010 Massachusetts Medical Society |
Chemical References |
- Anti-Infective Agents
- Gastrointestinal Agents
- Rifamycins
- Lactulose
- Rifaximin
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Topics |
- Aged
- Anti-Infective Agents
(adverse effects, therapeutic use)
- Chronic Disease
- Clostridioides difficile
- Clostridium Infections
(etiology)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Gastrointestinal Agents
(therapeutic use)
- Hepatic Encephalopathy
(prevention & control)
- Hospitalization
(statistics & numerical data)
- Humans
- Intention to Treat Analysis
- Kaplan-Meier Estimate
- Lactulose
(therapeutic use)
- Liver Cirrhosis
(drug therapy, mortality)
- Male
- Middle Aged
- Proportional Hazards Models
- Rifamycins
(adverse effects, therapeutic use)
- Rifaximin
- Secondary Prevention
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