PMID- 24697851
OWN - NLM
STAT- MEDLINE
DCOM- 20140926
LR  - 20220409
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 39
IP  - 10
DP  - 2014 May
TI  - Safety and tolerability of rifaximin for the treatment of irritable bowel 
      syndrome without constipation: a pooled analysis of randomised, double-blind, 
      placebo-controlled trials.
PG  - 1161-8
LID - 10.1111/apt.12735 [doi]
AB  - BACKGROUND: The efficacy of rifaximin, a nonsystemic, gut-targeted antibiotic for 
      reducing non-constipation-predominant irritable bowel syndrome (non-C IBS) 
      symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, 
      double-blind, placebo-controlled trials, but detailed data about rifaximin safety 
      and tolerability during treatment and subsequent follow-up periods are lacking. 
      AIM: To assess and determine the frequency of rifaximin and placebo adverse 
      events (AEs) in phase 2b and phase 3 non-C IBS trials. METHODS: A post hoc pooled 
      safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 
      2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three 
      times daily for 2 weeks) studies was performed. Data on treatment and 
      post-treatment AEs were collected. Patients were followed up for 12 weeks and 10 
      weeks post-treatment in the phase 2b and phase 3 trials, respectively. RESULTS: 
      Patients receiving rifaximin (n = 1103) and placebo (n = 829) had a similar 
      incidence of drug-related AEs (12.1% vs. 10.7%), serious AEs (1.5% vs. 2.2%), 
      drug-related AEs resulting in study discontinuation (0.8% vs. 0.8%), 
      gastrointestinal-associated AEs (12.2% vs. 12.2%) and infection-associated AEs 
      (8.5% vs. 9.5%). There were no cases of Clostridium difficile colitis or deaths. 
      CONCLUSIONS: The safety and tolerability profile of rifaximin during treatment 
      and post-treatment was comparable to placebo. Future research should define the 
      safety and tolerability profile, including risk of C. difficile colitis and 
      microbial antibiotic resistance, with repeated courses of rifaximin in patients 
      with non-constipation-predominant irritable bowel syndrome (ClinicalTrials.gov: 
      NCT00269412, NCT00731679, and NCT00724126).
CI  - (c) 2014 The Authors. Alimentary Pharmacology & Therapeutics published by John 
      Wiley & Sons Ltd.
FAU - Schoenfeld, P
AU  - Schoenfeld P
AD  - University of Michigan School of Medicine, Ann Arbor, MI, USA.
FAU - Pimentel, M
AU  - Pimentel M
FAU - Chang, L
AU  - Chang L
FAU - Lembo, A
AU  - Lembo A
FAU - Chey, W D
AU  - Chey WD
FAU - Yu, J
AU  - Yu J
FAU - Paterson, C
AU  - Paterson C
FAU - Bortey, E
AU  - Bortey E
FAU - Forbes, W P
AU  - Forbes WP
LA  - eng
SI  - ClinicalTrials.gov/NCT00269412
SI  - ClinicalTrials.gov/NCT00724126
SI  - ClinicalTrials.gov/NCT00731679
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20140403
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Rifamycins)
RN  - L36O5T016N (Rifaximin)
SB  - IM
CIN - Aliment Pharmacol Ther. 2014 Jul;40(2):208. PMID: 24946058
CIN - Aliment Pharmacol Ther. 2014 Jul;40(2):209. PMID: 24946060
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/adverse effects/therapeutic use
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Gastrointestinal Agents/*adverse effects/therapeutic use
MH  - Humans
MH  - Irritable Bowel Syndrome/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Rifamycins/*adverse effects/therapeutic use
MH  - Rifaximin
MH  - Young Adult
PMC - PMC4112801
EDAT- 2014/04/05 06:00
MHDA- 2014/09/27 06:00
CRDT- 2014/04/05 06:00
PHST- 2013/10/03 00:00 [received]
PHST- 2013/10/19 00:00 [revised]
PHST- 2014/03/14 00:00 [revised]
PHST- 2014/03/15 00:00 [accepted]
PHST- 2014/04/05 06:00 [entrez]
PHST- 2014/04/05 06:00 [pubmed]
PHST- 2014/09/27 06:00 [medline]
AID - APT12735 [pii]
AID - 10.1111/apt.12735 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2014 May;39(10):1161-8. doi: 10.1111/apt.12735. Epub 2014 
      Apr 3.