PMID- 25339518
OWN - NLM
STAT- MEDLINE
DCOM- 20150601
LR  - 20240322
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 41
IP  - 1
DP  - 2015 Jan
TI  - Prolonged remission from hepatic encephalopathy with rifaximin: results of a 
      placebo crossover analysis.
PG  - 39-45
LID - 10.1111/apt.12993 [doi]
AB  - BACKGROUND: Rifaximin therapy reduced risk of hepatic encephalopathy (HE) 
      recurrence and HE-related hospitalisations during a 6-month, randomised, 
      placebo-controlled trial (RCT) and a 24-month open-label maintenance (OLM) study. 
      However, the impact of crossover from placebo to rifaximin therapy is unclear. 
      AIM: To study the impact of crossing over from placebo to rifaximin treatment on 
      breakthrough HE and hospitalisation rates using a within-subjects design. 
      METHODS: Adults with cirrhosis and history of overt HE episodes, currently in HE 
      remission, received placebo during the RCT and crossed over to rifaximin 550 mg 
      twice daily during the OLM study. Rate of breakthrough overt HE episodes, 
      hospitalisations and incidence and rate of adverse events (AEs) were analysed 
      during RCT and first 6 months of OLM. RESULTS: Of 82 patients randomised to 
      placebo in the RCT who crossed over to the OLM study, 39 experienced an HE 
      episode during the RCT compared with 14 during the OLM study (P < 0.0001). 
      Significantly lower rates of HE events were observed with rifaximin treatment 
      compared with placebo treatment (P < 0.0001). Rates of HE-related hospitalisation 
      were numerically lower during rifaximin treatment compared with placebo 
      treatment, although not significant. Rates of most common AEs, serious AEs and 
      infection-related AEs were similar between the two treatments. CONCLUSIONS: This 
      analysis confirms the repeatability of results from the RCT on safety and 
      efficacy of rifaximin 550 mg twice daily in reducing the risk of hepatic 
      encephalopathy recurrence, and suggests these findings are translatable outside 
      of a rigorous, controlled trial setting.
CI  - (c) 2014 The Authors. Alimentary Pharmacology & Therapeutics published by John 
      Wiley & Sons Ltd.
FAU - Bajaj, J S
AU  - Bajaj JS
AD  - Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth 
      University and McGuire VA Medical Center, Richmond, VA, USA.
FAU - Barrett, A C
AU  - Barrett AC
FAU - Bortey, E
AU  - Bortey E
FAU - Paterson, C
AU  - Paterson C
FAU - Forbes, W P
AU  - Forbes WP
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20141022
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Rifamycins)
RN  - L36O5T016N (Rifaximin)
SB  - IM
CIN - Aliment Pharmacol Ther. 2015 Jan;41(2):228. PMID: 25511766
MH  - Aged
MH  - Anti-Infective Agents/adverse effects/*therapeutic use
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Hepatic Encephalopathy/*drug therapy/etiology
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Incidence
MH  - Liver Cirrhosis/complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Recurrence
MH  - Remission Induction
MH  - Research Design
MH  - Rifamycins/adverse effects/*therapeutic use
MH  - Rifaximin
PMC - PMC4284039
EDAT- 2014/10/24 06:00
MHDA- 2015/06/02 06:00
CRDT- 2014/10/24 06:00
PHST- 2014/04/28 00:00 [received]
PHST- 2014/06/09 00:00 [revised]
PHST- 2014/09/12 00:00 [revised]
PHST- 2014/09/29 00:00 [accepted]
PHST- 2014/10/24 06:00 [entrez]
PHST- 2014/10/24 06:00 [pubmed]
PHST- 2015/06/02 06:00 [medline]
AID - 10.1111/apt.12993 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2015 Jan;41(1):39-45. doi: 10.1111/apt.12993. Epub 2014 
      Oct 22.