Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis.
OBJECTIVE
Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled, multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis.


METHODS
Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk, n = 30), mesalamine granules (3 g mesalamine once daily, Salofalk, n = 25), or placebo for 8 weeks (n = 37) in a double-blind, double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom. The primary end point was clinical remission at 8 weeks defined as ≤ 3 stools per day. Secondary end points included clinical remission at 8 weeks, according to the Hjortswang-Criteria of disease activity, taking stool consistency into account.


RESULTS
A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group (intention-to-treat analysis, 80.0% vs 59.5%; P = .072; per-protocol analysis, 84.8% vs 60.6%; P = .046). Based on the Hjortswang-Criteria, 80.0% of patients given budesonide achieved clinical remission compared with 37.8% of patients given placebo (P = .0006); 44.0% of patients given mesalamine achieved clinical remission, but budesonide was superior to mesalamine (P = .0035). Budesonide significantly improved stool consistency and mucosal histology, and alleviated abdominal pain. The rate of adverse events did not differ among groups.


CONCLUSIONS
Oral budesonide (9 mg once daily) is effective and safe for short-term treatment of collagenous colitis. Short-term treatment with oral mesalamine (3 g once daily) appears to be ineffective. ClinicalTrials.gov number, NCT00450086.
Center for Digestive Diseases Eppendorf, Hamburg, Germany. Electronic address: prof.miehlke@mdz-hamburg.de.
Stephan
S
Miehlke
Medical Department I, Siloah Hospital, Hannover, Germany.
Ahmed
A
Madisch
Institute for Digestive Research, Lithuanian, University of Health Sciences, Kaunas, Lithuania.
Limas
L
Kupcinskas
Institute for Digestive Research, Lithuanian, University of Health Sciences, Kaunas, Lithuania.
Dalius
D
Petrauskas
Private Practice, Ludwigshafen, Germany.
Günter
G
Böhm
Private Practice, Siegen, Germany.
Hans-Joachim
HJ
Marks
Private Practice, Oldenburg, Germany.
Michael
M
Neumeyer
Vejle Sygehus, Vejle, Denmark.
Torben
T
Nathan
Department of Gastroenterology, Hospital Universitario Mutua Terrassa, Terrassa, Spain.
Fernando
F
Fernández-Bañares
Dr Falk Pharma GmbH, Freiburg, Germany.
Roland
R
Greinwald
Dr Falk Pharma GmbH, Freiburg, Germany.
Ralf
R
Mohrbacher
Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.
Michael
M
Vieth
Diagnostic Center, Silkeborg Hospital, Silkeborg, Denmark.
Ole K
OK
Bonderup
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D046729:Colitis, Collagenous / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D003672:Defecation / Q000187:drug effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D002214:Capsules; D003692:Delayed-Action Preparations; D005765:Gastrointestinal Agents; D019804:Mesalamine; D019819:Budesonide
Clinical Trial; Drug; Microscopic Colitis; Therapy