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Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis
Internal Med Ctr Eppendorf, Germany.
Tech Univ Dresden, Germany.
Semmelweis Univ, Hungary.
Gastroenterology, Private Practice, Berlin, Germany.
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2018 (English)In: Gastroenterology, ISSN 0016-5085, E-ISSN 1528-0012, Vol. 155, no 6, p. 1795-+Article in journal (Refereed) Published
Abstract [en]

BACKGROUND amp; 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 amp;lt;= 21 stools (including amp;lt;= 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.

Place, publisher, year, edition, pages
W B SAUNDERS CO-ELSEVIER INC , 2018. Vol. 155, no 6, p. 1795-+
Keywords [en]
Corticosteroid; 5-Aminosalicylic Acid; Microscopic Colitis; Intraepithelial Lymphocytes
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Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:liu:diva-153520DOI: 10.1053/j.gastro.2018.08.042ISI: 000451781000033PubMedID: 30195447OAI: oai:DiVA.org:liu-153520DiVA, id: diva2:1274600
Note

Funding Agencies|Dr Falk Pharma GmbH, Freiburg, Germany; Dr Falk Pharma GmbH

Available from: 2019-01-02 Created: 2019-01-02 Last updated: 2019-05-01

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Münch, Andreas

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Division of Neuro and Inflammation ScienceFaculty of Medicine and Health SciencesDepartment of Gastroentorology
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