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Evaluation of the efficacy and safety of rifaximin in the treatment of hepatic encephalopathy: a double-blind, randomized, dose-finding multi-centre study.

AbstractOBJECTIVE:
To determine the efficacy, tolerability and safety of oral rifaximin given at three dose levels in patients with cirrhosis and mild to moderate hepatic encephalopathy (HE).
DESIGN:
Prospective, double-blind, randomized, parallel-group study.
SETTING:
Multi-centre trial in four university teaching hospitals.
PARTICIPANTS:
Fifty-four patients with cirrhosis and mild to moderate HE.
INTERVENTION:
Seven days treatment with rifaximin, 600, 1200 or 2400 mg/day in three divided doses.
MAIN OUTCOME MEASURE:
Change in the portal-systemic encephalopathy (PSE) index between baseline and day 7, calculated on the basis of mental state, asterixis, number connection test time, EEG mean cycle frequency and blood ammonia concentrations.
RESULTS:
Treatment with rifaximin was associated with an improvement in the PSE index. There was a trend towards a greater treatment effect of rifaximin with the highest dose of 2400 mg/day. Rifaximin was well tolerated; the few treatment-related adverse events showed no consistent pattern or dose relationship.
CONCLUSION:
Rifaximin may be useful as alternative or adjuvant therapy for grade I-III hepatic encephalopathy in patients with cirrhosis at a dose of 1200 mg/day.
AuthorsR Williams, O F James, T W Warnes, M Y Morgan
JournalEuropean journal of gastroenterology & hepatology (Eur J Gastroenterol Hepatol) Vol. 12 Issue 2 Pg. 203-8 (Feb 2000) ISSN: 0954-691X [Print] ENGLAND
PMID10741936 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Gastrointestinal Agents
  • Rifamycins
  • rifaximin
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gastrointestinal Agents (administration & dosage, therapeutic use)
  • Hepatic Encephalopathy (drug therapy)
  • Humans
  • London
  • Male
  • Middle Aged
  • Prospective Studies
  • Rifamycins (administration & dosage, therapeutic use)
  • Severity of Illness Index
  • Treatment Outcome

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