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Rifaximin treatment in hepatic encephalopathy.

AbstractBACKGROUND:
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.)
AuthorsNathan 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
JournalThe 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
PMID20335583 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright2010 Massachusetts Medical Society
Chemical References
  • Anti-Infective Agents
  • Gastrointestinal Agents
  • Rifamycins
  • Lactulose
  • rifaximin
Topics
  • Aged
  • Anti-Infective Agents (adverse effects, therapeutic use)
  • Chronic Disease
  • Clostridium Infections (etiology)
  • Clostridium difficile
  • 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)
  • Secondary Prevention

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