SNFGE SNFGE
 
Thématique :
- Colo-proctologie
Originalité :
Intermédiaire
Solidité :
A confirmer
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Docteur Pauline JOUET
Coup de coeur :
 
 
Gastroenterology
  2016/12  
 
  2016 Dec;151(6):1113-1121  
  doi: 10.1053/j.gastro.2016.08.003  
 
  Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome.  
 
  Lembo A, Pimentel M, Rao SS, Schoenfeld P, Cash B, Weinstock LB, Paterson C, Bortey E, Forbes WP  
  https://www.ncbi.nlm.nih.gov/pubmed/27528177  
 
 

Abstract

BACKGROUND & AIMS:

Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome (IBS-D). A phase 3, randomized, double-blind, placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin.

METHODS:

The trial included adults with IBS-D, mean abdominal pain and bloating scores of 3 or more, and loose stool, located at 270 centers in the United States and Europe from February 2012 through June 2014. Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily, who then relapsed during an observation phase (up to 18 weeks), were randomly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks. The primary end point was percentage of responders after first repeat treatment, defined as a decrease in abdominal pain of ≥30% from baseline and a decrease in frequency of loose stools of ≥50% from baseline, for 2 or more weeks during a 4-week post-treatment period.

RESULTS:

Of 1074 patients (44.1%) who responded to open-label rifaximin, 382 (35.6%) did not relapse and 692 (64.4%) did; of these, 636 were randomly assigned to receive repeat treatment with rifaximin (n = 328) or placebo (n = 308). The percentage of responders was significantly greater with rifaximin than placebo (38.1% vs 31.5%; P = .03). The percentage of responders for abdominal pain (50.6% vs 42.2%; P = .018) was significantly greater with rifaximin than placebo, but not stool consistency (51.8% vs 50.0%; P = .42). Significant improvements were also noted for prevention of recurrence, durable response, and bowel movement urgency. Adverse event rates were low and similar between groups.

CONCLUSIONS:

In a phase 3 study of patients with relapsing symptoms of IBS-D, repeat rifaximin treatment was efficacious and well tolerated.

 

 
Question posée
 
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Question posée
 
Dans cette étude randomisée en double aveugle comparant l’effet de la rifaximine prise trois fois par jour (n=328 patients) pendant 2 semaines à un placebo (n=308 patients), les patients sous rifaximine avaient significativement moins de symptômes (38,1% vs 31,5% ; p = 0,03) et de douleurs abdominales, sans modification de la consistance de selles, ni d’effet sur les ballonnements.
 
Commentaires

Un effet significatif mais qui semble quand même très modeste par rapport au placebo et moins efficace sur les symptômes que lors du premier traitement, pour un traitement coûteux qui ne peut pas encore être prescrit en France dans cette indication.

 
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