SNFGE SNFGE
 
Thématique :
- Colo-proctologie
Originalité :
Intermédiaire
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Docteur Pauline JOUET
Coup de coeur :
 
 
Gastroenterology
  2018/12  
 
  2018 Dec;155(6):1795-1804.e3.  
  doi: 10.1053/j.gastro.2018.08.042.  
 
  Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis.  
 
  Miehlke S, Aust D, Mihaly E, Armerding P, Böhm G, Bonderup O, Fernández-Bañares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Münch A; BUG-1/LMC Study Group.  
  https://www.ncbi.nlm.nih.gov/pubmed/30195447  
 
 

Abstract

BACKGROUND & AIMS:

Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis.

METHODS:

Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8.

RESULTS:

The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P = .01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P = .09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P = .02) or placebo (21%; P = .008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group.

CONCLUSIONS:

In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

 

 
Question posée
 
Quelle est l’efficacité du budesonide en comparaison à la mesalazine et à un placebo pour induire une rémission clinique en cas de colite lymphocytaire ?
 
Question posée
 
Dans cette étude multicentrique randomisée contrôlée en double aveugle portant sur 57 patients, le budésonide à 9mg/j était significativement plus efficace pour induire une rémission clinique à 8 semaines que le placebo (79% vs 42%; P =0,01), alors que l’effet de la mesalazine était similaire à celui du placebo.
 
Commentaires

Un traitement rapidement efficace (dans les deux semaines) chez 8 malades sur 10, à utiliser en première intention dans le traitement de la colite lymphocytaire.

 
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