Low-dose budesonide for maintenance of clinical remission in collagenous colitis: A randomised, placebo-controlled, 12-month trial

Gut

Volumn 65, Issue 1, 2016, Pages 47-56

  Münch, Andreas ^a   Bohr, Johan ^b   Miehlke, Stephan ^c   Benoni, Cecilia ^d   Olesen, Martin ^d   Öst, Åke ^e   Strandberg, Lars ^f   Hellström, Per M ^g   Hertervig, Erik ^d   Armerding, Peter ^h   Stehlik, Jiri ⁱ   Lindberg, Greger ^j   Björk, Jan ^j   Lapidus, Annika ^k   Löfberg, Robert ^l   Bonderup, Ole ^m   Avnström, Sören ⁿ   Rössle, Martin ^o   Dilger, Karin ^p   Mueller, Ralph ^p   Greinwald, Roland ^p   Tysk, Curt ^b   Ström, Magnus ^a   more..

^a LINKÖPING UNIVERSITY   (Sweden)

^b ÖREBRO UNIVERSITY   (Sweden)

^c Center for Digestive Diseases   (Germany)

^d LUND UNIVERSITY HOSPITAL   (Sweden)

^e Aleris Medilab ^*  (Sweden)

^f Department of Obstetrics   (Sweden)

^g UPPSALA UNIVERSITY   (Sweden)

^h Campus Virchow Klinikum   (Germany)

ⁱ Department of Pathology Regional Hospital   (Czech Republic)

^j KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^k ERSTA HOSPITAL   (Sweden)

^l Sophiahemmet AB   (Sweden)

^m SILKEBORG REGIONAL HOSPITAL   (Denmark)

ⁿ AMAGER HOSPITAL   (Denmark)

^o Gastroenterology   (Germany)

^p Dr Falk Pharma   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BUDENOFALK; BUDESONIDE; ANTIINFLAMMATORY AGENT;

ABDOMINAL DISCOMFORT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTHRITIS; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BREAST DISEASE; COLLAGENOUS COLITIS; CONNECTIVE TISSUE DISEASE; CONSTIPATION; CONTROLLED STUDY; DIABETES MELLITUS; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INTOXICATION; DRUG RESPONSE; DRUG SAFETY; EAR DISEASE; ECCHYMOSIS; ECZEMA; ERYTHEMA; EYE DISEASE; FEMALE; FLATULENCE; GASTROINTESTINAL DISEASE; GENITAL SYSTEM DISEASE; GLAUCOMA; HEADACHE; HEART DISEASE; HEART PALPITATION; HEPATOBILIARY DISEASE; HUMAN; HYPERHIDROSIS; HYPERTENSION; INCREASED APPETITE; INFECTION; INJURY; INNER EAR DISEASE; LOW DRUG DOSE; MAINTENANCE THERAPY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; MOOD DISORDER; MUSCLE SPASM; NAUSEA; NEUROLOGIC DISEASE; NIGHT SWEAT; NUTRITIONAL DISORDER; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN BLEEDING; SKIN DISEASE; SUBCUTANEOUS HEMORRHAGE; SWELLING; THORAX DISEASE; TREATMENT DURATION; TREATMENT OUTCOME; VAGINITIS; VASCULAR DISEASE; VERTIGO; AGED; CLINICAL TRIAL; COLITIS, COLLAGENOUS; DRUG ADMINISTRATION; FOLLOW UP; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; MULTICENTER STUDY; PROCEDURES;

ADULT; AGED; ANTI-INFLAMMATORY AGENTS; BUDESONIDE; COLITIS, COLLAGENOUS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84955571349     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2014-308363     Document Type: Article

References (15)

1. Münch A, Aust D, Bohr J, et al. Microscopic colitis: current status, present and future challenges: statements of the European Microscopic Colitis Group. J Crohns Colitis 2012;6:932-45.
2. Hjortswang H, Tysk C, Bohr J, et al. Health-related quality of life is impaired in active collagenous colitis. Dig Liver Dis 2011;43:102-9.
3. Baert F, Schmit A, D'Haens G, et al. Budesonide in collagenous colitis: a double-blind placebo-controlled trial with histologic follow-up. Gastroenterology 2002;122:20-5.
4. Bonderup OK, Hansen JB, Birket-Smith L, et al. Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis. Gut 2003;52:248-51.
5. Bonderup OK, Hansen JB, Teglbjaerg PS, et al. Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial. Gut 2009;58:68-72.
6. Miehlke S, Heymer P, Bethke B, et al. Budesonide treatment for collagenous colitis: a randomized, double-blind, placebo-controlled, multicenter trial. Gastroenterology 2002;123:978-4.
7. Miehlke S, Madisch A, Bethke B, et al. Oral budesonide for maintenance treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2008;135:1510-16.
8. Miehlke S, Madisch A, Kupcinskas L, et al. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology 2014;146:1222-30.e2.
9. Stewart MJ, Seow CH, Storr MA. Prednisolone and budesonide for short- and long-term treatment of microscopic colitis: systematic review and meta-analysis. Clin Gastroenterol Hepatol 2011;9:881-90.
10. Miehlke S, Madisch A, Voss C, et al. Long-term follow-up of collagenous colitis after induction of clinical remission with budesonide. Aliment Pharmacol Ther 2005;22:1115-19.
11. Miehlke S, Hansen JB, Madisch A, et al. Risk factors for symptom relapse in collagenous colitis after withdrawal of short-term budesonide therapy. Inflamm Bowel Dis 2013;19:2763-7.
12. Hjortswang H, Tysk C, Bohr J, et al. Defining clinical criteria for remission and disease activity in collagenous colitis. Inflamm Bowel Dis 2009;15:1875-81.
13. Hjortswang H, Jarnerot G, Curman B, et al. The Short Health Scale: a valid measure of subjective health in ulcerative colitis. Scand J Gastroenterol 2006;41: 1196-203.
14. Dupuy HJ. The Psychological General Well-Being (PGWB) Index. In: Wenger NK, Mattson ME, Furberg CF, Elinson J. eds. Assessment of quality of life in clinical trials of cardiovascular therapies. Washington, DC, USA: Le Jacq Publishing Inc., 1984:170-83.
15. Stjernman H, Grännö C, Järnerot G, et al. Short Health Scale: a valid, reliable, and responsive instrument for subjective health assessment in Crohn's disease. Inflamm Bowel Dis 2008;14:47-52.