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Efficacy and Safety...
Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis
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- Miehlke, Stephan (author)
- Internal Med Ctr Eppendorf, Germany
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- Aust, Daniela (author)
- Tech Univ Dresden, Germany
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- Mihaly, Emese (author)
- Semmelweis Univ, Hungary
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- Armerding, Peter (author)
- Gastroenterology, Private Practice, Berlin, Germany
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- Boehm, Guenther (author)
- Internal Medicine and Cardiology, Private Practice, Ludwigshafen am Rhein, Germany
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- Bonderup, Ole (author)
- Reg Hosp Silkeborg, Denmark
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- Fernandez-Banares, Fernando (author)
- Hosp Univ Mutua Terrassa, Spain
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- Kupcinskas, Juozas (author)
- Lithuanian Univ Hlth Sci, Lithuania
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- Munck, Lars Kristian (author)
- Zealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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- Rehbehn, Kai-Uwe (author)
- Gastroenterology, Private Practice, Solingen, Germany
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- Nacak, Tanju (author)
- Dr Falk Pharma GmbH, Germany
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- Greinwald, Roland (author)
- Dr Falk Pharma GmbH, Germany
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- Münch, Andreas, 1970- (author)
- Linköpings universitet,Avdelningen för neuro- och inflammationsvetenskap,Medicinska fakulteten,Region Östergötland, Magtarmmedicinska kliniken
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(creator_code:org_t)
- W B SAUNDERS CO-ELSEVIER INC, 2018
- 2018
- English.
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In: Gastroenterology. - : W B SAUNDERS CO-ELSEVIER INC. - 0016-5085 .- 1528-0012. ; 155:6, s. 1795-
- Related links:
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http://www.gastrojou...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Keyword
- Corticosteroid; 5-Aminosalicylic Acid; Microscopic Colitis; Intraepithelial Lymphocytes
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Miehlke, Stephan
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Aust, Daniela
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Mihaly, Emese
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Armerding, Peter
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Boehm, Guenther
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Bonderup, Ole
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Fernandez-Banare ...
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Kupcinskas, Juoz ...
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Munck, Lars Kris ...
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Rehbehn, Kai-Uwe
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Nacak, Tanju
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Greinwald, Rolan ...
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Münch, Andreas, ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Gastroenterology ...
- Articles in the publication
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Gastroenterology
- By the university
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Linköping University