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Clinical Trial
. 2010 Mar 25;362(12):1071-81.
doi: 10.1056/NEJMoa0907893.

Rifaximin treatment in hepatic encephalopathy

Nathan M Bass  1 , 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
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Clinical Trial

VSports注册入口 - Rifaximin treatment in hepatic encephalopathy

Nathan M Bass et al. N Engl J Med. .
Free article

Abstract (VSports最新版本)

Background: Hepatic encephalopathy is a chronically debilitating complication of hepatic cirrhosis VSports手机版. 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. V体育安卓版.

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 V体育ios版. 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 VSports最新版本. ) .

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