Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: A three-year randomized trial

Hepatology

Volumn 41, Issue 4, 2005, Pages 747-752

  Rautiainen, Henna ^a   Kärkkäinen, Päivi ^a   Karvonen, A L ^b   Nurmi, Heimo ^c   Pikkarainen, Pekka ^b   Nuutinen, Hannu ^a   Färkkilä, Martti ^a  

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b TAMPERE UNIVERSITY HOSPITAL   (Finland)

^c TURKU UNIVERSITY HOSPITAL   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; GLUCOSE; HYDROCORTISONE; URSODEOXYCHOLIC ACID;

ACNE; ADULT; AGED; ARTICLE; BILIRUBIN BLOOD LEVEL; CAPILLARY RESISTANCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DRUG EFFECT; DRUG SAFETY; ENZYME ASSAY; FEMALE; FOLLOW UP; GLUCOSE BLOOD LEVEL; HIRSUTISM; HISTOPATHOLOGY; HUMAN; HYDROCORTISONE BLOOD LEVEL; INFLAMMATION; LABORATORY TEST; LIVER BIOPSY; LIVER FIBROSIS; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN ATROPHY; SKIN MANIFESTATION; TREATMENT OUTCOME; WEIGHT GAIN;

ADULT; AGED; BUDESONIDE; DRUG THERAPY, COMBINATION; GLUCOCORTICOIDS; HUMANS; LIVER; LIVER CIRRHOSIS; LIVER CIRRHOSIS, BILIARY; MIDDLE AGED; PROSPECTIVE STUDIES; URSODEOXYCHOLIC ACID;

EID: 16244417776     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.20646     Document Type: Article

References (22)

1. Kaplan MM. Primary biliary cirrhosis [Rreview]. N Engl J Med 1996;335:1570-1578.
2. Poupon RE, Poupon R, Balkau B, UDC-PBC Study Group. Ursodiol for the long-term treatment of primary biliary cirrhosis. N Engl J Med 1994;330:1342-1347.
3. Combes B, Carithers RL, Maddrey WC, Lin D, McDonald MF, Wheeler DE, et al. A randomized double blind, placebo-controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. HEPATOLOGY 1995;22:759-766.
4. Goulis J, Leandro G, Burroughs A. Randomised controlled trials of ursodeoxycholic acid therapy for primary biliary cirrhosis: a meta-analysis. Lancet 1999;354(9184):1053-1060.
5. Poupon RE, Lindor KD, Cauch-Dudek K, Dickson ER, Poupon R, Heathcote J. Combined analysis of randomized trials of ursodeoxycholic acid in primary biliary cirrhosis. Gastroenterology 1997;113:884-890.
6. Gluud C, Christensen E. Ursodeoxycholic acid for primary biliary cirrhosis. Cochrane Database Syst Rev 2002;CD000551.
7. Poupon RE, Lindor KD, Pares A, Chazouilleres O, Poupon R, Heathcote EJ. Combined analysis of the effect of treatment with ursodeoxycholic acid on histologic progression in primary biliary cirrhosis. J Hepatol 2003;39:12-16.
8. Papatheodoridis GV, Hadziyannis ES, Deusch M, Hadziyannis SJ. Ursodeoxycholic acid for primary biliary cirrhosis: final results of a 12-year prospective randomized, controlled trial. Am J Gastroenterol 2002;97:2063-2070.
9. Leuschner M, Güldütuna S, You T, Hübner K, Bhatti S, Leuschner U. Ursodeoxy cholic acid and prednisolone versus ursodeoxycholic acid and placebo in the treatment of early stages of primary biliary cirrhosis. J Hepatol 1996;25:49-57.
10. Möllmann HW, Barth J, Hochhaus G, Möllman AC, Derendorf H, Tromm A. Principles of topical versus systemic corticoid treatment in inflammatory bowel disease. In: Möllmann HW, May B, eds. Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease. From Basic Principles to Rational Therapy. Boston: Kluwer, 1996:42-60.
11. Greenberg GR, Feagan BG, Martin F, Sutherland LR, Thoson AB, Williams CN, et al. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Eng J Med 1994;331:836-841.
12. Ryrfeldt A, Andersson P, Edsbacker S, Tonnesson M, Davies D, Pauwels R. Phasmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur J Respir Dis Suppl 1982;122:86-95.
13. Jonsson G, Astrom A, Andersson P. Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metab Dispos 1995;23:137-142.
14. Hempfling W, Grunhage F, Dilger K, Reichel C, Beuers U, Sauerbruch T. Pharmacokinetics and pharmacodynamic action of budesonide in early- and late-stage primary biliary cirrhosis. HEPATOLOGY 2003;38:196-202.
15. Leuschner M, Maier K-P, Schlichting J, Strahl S, Herrmann G, Dahm HH, et al. Oral budesonide and ursodeoxycholic acid for treatment of primary biliary cirrhosis: results of a prospective double-blind trial. Gastroenterology 1999;117:918-925.
16. Angulo P, Jorgensen RA, Keach JC, Dickson ER, Smith C, Lindor KD. Oral budesonide in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid. HEPATOLOGY 2000;31:318-323.
17. Ludwig J, Dicson ER, McDonald GS. Staging of chronic nonsuppurative destructive cholangitis (syndrome of biliary cirrhosis). Virchows Arch A 1978;379:103-112.
18. Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. HEPATOLOGY 1996;24:289-293.
19. Locke GR III, Therneau TM, Ludwig J, Dickson ER, Lindor KD. Time course of histological progression in primary biliary cirrhosis. HEPATOLOGY 1996;23:52-56.
20. Corpechot C, Carrat F, Bonnand A-M, Poupon RE, Poupon R. The effect of ursodeoxycholic acid therapy on liver fibrosis progression in primary biliary cirrhosis. HEPATOLOGY 2000;122:32:1196-1199.
21. Corpechot C, Carrat F, Poupon RE, Poupon R. Primary biliary cirrhosis: incidence and predictive factors of cirrhosis development in ursodiol treated patients. Gastroenterology 2002;122:652-658.
22. Leuschner M, Dietrich CF, You T, Seidl C Raedle J, Herrmann G, et al. Characterisation of patients with primary biliary cirrhosis responding to long term ursodeoxycholic acid treatment. Gut 2000;46:121-126.