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Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis.
- Source :
-
Gastroenterology [Gastroenterology] 2018 Dec; Vol. 155 (6), pp. 1795-1804.e3. Date of Electronic Publication: 2018 Sep 07. - Publication Year :
- 2018
-
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.<br />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.<br />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.<br />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.<br /> (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Oral
Anti-Inflammatory Agents administration & dosage
Budesonide administration & dosage
Colitis, Lymphocytic pathology
Double-Blind Method
Drug Administration Schedule
Female
Humans
Induction Chemotherapy
Male
Mesalamine administration & dosage
Middle Aged
Treatment Outcome
Anti-Inflammatory Agents therapeutic use
Budesonide therapeutic use
Colitis, Lymphocytic drug therapy
Mesalamine therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 155
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 30195447
- Full Text :
- https://doi.org/10.1053/j.gastro.2018.08.042