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Sökning: onr:"swepub:oai:DiVA.org:liu-153520" > Efficacy and Safety...

Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Miehlke, Stephan (författare)
Internal Med Ctr Eppendorf, Germany
Aust, Daniela (författare)
Tech Univ Dresden, Germany
Mihaly, Emese (författare)
Semmelweis Univ, Hungary
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Armerding, Peter (författare)
Gastroenterology, Private Practice, Berlin, Germany
Boehm, Guenther (författare)
Internal Medicine and Cardiology, Private Practice, Ludwigshafen am Rhein, Germany
Bonderup, Ole (författare)
Reg Hosp Silkeborg, Denmark
Fernandez-Banares, Fernando (författare)
Hosp Univ Mutua Terrassa, Spain
Kupcinskas, Juozas (författare)
Lithuanian Univ Hlth Sci, Lithuania
Munck, Lars Kristian (författare)
Zealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
Rehbehn, Kai-Uwe (författare)
Gastroenterology, Private Practice, Solingen, Germany
Nacak, Tanju (författare)
Dr Falk Pharma GmbH, Germany
Greinwald, Roland (författare)
Dr Falk Pharma GmbH, Germany
Münch, Andreas, 1970- (författare)
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
Engelska.
Ingår i: Gastroenterology. - : W B SAUNDERS CO-ELSEVIER INC. - 0016-5085 .- 1528-0012. ; 155:6, s. 1795-
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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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.

Ämnesord

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

Corticosteroid; 5-Aminosalicylic Acid; Microscopic Colitis; Intraepithelial Lymphocytes

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