Methotrexate (MTX) plus ursodeoxycholic acid (UDCA) in the treatment of primary biliary cirrhosis

Hepatology

Volumn 42, Issue 5, 2005, Pages 1184-1193

  Combes, Burton ^a   Emerson, Scott S ^b   Flye, Nancy L ^b   Munoz, Santiago J ^c   Luketic, Velimir A ^d   Mayo, Marlyn J ^a   McCashland, Timothy M ^e   Zetterman, Rowen K ^e   Peters, Marion G ^f   Di Bisceglie, Adrian M ^g   Benner, Kent G ^h   Kowdley, Kris V ⁱ   Carithers Jr , Robert L ⁱ   Rosoff Jr , Leonard ^j   Garcia Tsao, Guadalupe ^k   Boyer, James L ^k   Boyer, Thomas D ^l   Martinez, Enrique J ^l   Bass, Nathan M ^m   Lake, John R ^m   Barnes, David S ⁿ   Bonacini, Maurizio ^o   Lindsay, Karen L ^o   Mills, A Scott ^d   Markin, Rodney S ^e   Rubin, Raphael ^c   West, A Brian ^k,p   Wheeler, Donald E ^a,q   Contos, Melissa J ^d   Hofmann, Alan F ^r   more..

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c THOMAS JEFFERSON UNIVERSITY   (United States)

^d VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^f WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

ⁱ UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^j VIRGINIA MASON MEDICAL CENTER   (United States)

^k YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^l EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m UNIVERSITY OF CALIFORNIA   (United States)

ⁿ LERNER RESEARCH INSTITUTE   (United States)

^o UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^p UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^q UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^r UCSD MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; METHOTREXATE; PLACEBO; SERUM ALBUMIN; URSODEOXYCHOLIC ACID;

ADULT; AGED; ALBUMIN BLOOD LEVEL; ANOREXIA; ARTICLE; ASCITES; BILIRUBIN BLOOD LEVEL; BONE MARROW TOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOPENIA; DIARRHEA; DRUG TREATMENT FAILURE; ESOPHAGUS VARICES; ESOPHAGUS VARICES BLEEDING; FEMALE; GASTROINTESTINAL TOXICITY; HEPATIC ENCEPHALOPATHY; HUMAN; LIVER CANCER; LIVER TRANSPLANTATION; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; TREATMENT WITHDRAWAL;

ADULT; AGED; BILE; BILE ACIDS AND SALTS; CHOLAGOGUES AND CHOLERETICS; DRUG THERAPY, COMBINATION; ENDOSCOPY; FEMALE; HUMANS; LIVER CIRRHOSIS, BILIARY; MALE; METHOTREXATE; MIDDLE AGED; PREVALENCE; SURVIVAL ANALYSIS; TREATMENT FAILURE; URSODEOXYCHOLIC ACID; VARICOSE VEINS;

EID: 30944439354     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.20897     Document Type: Article

References (22)

1. Poupon R, Chretien Y, Poupon RE, Ballet F, Calmus Y, Darnis F. Is ursodeoxycholic acid an effective treatment for primary biliary cirrhosis? Lancet 1987;I(8537):834-836.
2. David R, Kurtz W, Strohm DW, Leuschner U. Die Wirkung von Ursodeoxycholsaeure bei chronischen Lebererkrankungen. Eine Pilotstudie. Z Gastroenterologie 1985;23:240.
3. Poupon RE, Balkau B, Eschwege E, Poupon R, the UDCA-PBC Study Group. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. New Engl J Med 1991;324:1548-1554.
4. Heathcote EJ, Cauch-Dudek K, Walter V, Bailey RJ, Blendis LM, Ghent CN, et al. The Canadian Multicenter Double-blind Randomized Controlled Trial of ursodeoxycholic acid in primary biliary cirrhosis. HEPATOLOGY 1994;19:1149-1156.
5. Lindor DL, Dickson ER, Baldus WP, Jorgensen RA, Ludwig J, Murtaugh PA, et al. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis. Gastroenterology 1994;106:1284-1290.
6. Combes B, Carithers RL Jr, Maddrey WB, 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.
7. Kaplan MM, Knox TZ, Arora S. Primary biliary cirrhosis treated with low-dose oral pulse methotrexate. Ann Intern Med 1998;109:429-431.
8. Kaplan MM. Methotrexate treatment of chronic cholestatic liver disease: friend or foe. Quart J Med 1989;268:757-761.
9. Kaplan MM, Knox TA. Treatment of primary biliary cirrhosis with low-dose weekly methotrexate. Gastroenterology 1991;101:1332-1338.
10. Bergasa NV, Jones A, Kleiner DE, Rabin L, Park Y, Wells MC, et al. Pilot study of low dose oral methotrexate treatment for primary biliary cirrhosis. Am J Gastroenterol 1996;91:295-299.
11. Buscher HP, Zietzschmann Y, Gerok W. Positive response to methotrexate and ursodeoxy-cholic acid in patients with primary biliary cirrhosis responding insufficiently to ursodeoxycholic acid alone. J Hepatol 1993;18: 9-14.
12. Lindor KD, Dickson ER, Jorgensen RA, Anderson ML, Wiesner RH, Gores GJ, et al. The combination of ursodeoxycholic acid and methotrexate for patients with primary biliary cirrhosis: the results of a pilot study. HEPATOLOGY 1995;22:1158-1162.
13. Ludwig J, Dickson ER, McDonald GS. Staging of chronic nonsuppurative destructive cholangitis (syndrome of primary biliary cirrhosis). Virchow's Arch A 1978;379:103-112.
14. Hosmer DWJr, Lemeshow S, eds. Applied Survival Analysis: Regression Modeling of Time to Event Data. Hoboken, NJ: Wiley, 1999.
15. Cox DR. Regression models and life tables (with discussion). J Royal Statistical Society 1972;B34:187-220.
16. Emerson SS, Fleming TR. Symmetric group sequential designs. Biometrics 1989;45:905-923.
17. Burington BE, Emerson SS. Flexible implementation of group sequential stopping rules using constrained boundaries. Biometrics 2003;59:770-777.
18. Emerson SS, Fleming TR. Parameter estimation following group sequential hypothesis testing. Biometrika 1990;77:875-892
19. Sharma A, Provenzale D, McKusick A, Kaplan MM. Interstitial pneumonias after low dose methotrexate therapy in primary biliary cirrhosis. Gastroenterology 1994;107:266-270.
20. Rossi SS, Converse JL, Hofmann AF. High pressure liquid chromatographic analysis of conjugated bile acids in human bile: simultaneous resolution of sulfated and unsulfated lithocholyl amidates and the common conjugated bile acids. J Lipid Res 1987;28:589-595.
21. Van Steenbergen W, Sciot R, Van Euken P, Desmet V, Fevery J. Combined treatment with methotrexate and ursodeoxycholic acid in non-cirrhotic primary biliary cirrhosis. Acta Clin Belgica 1996;51:8-18.
22. Gonzalez-Koch A, Brahm J, Antezana C, Smok G, Cumsille MA. The combination of ursodeoxy-cholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone. J Hepatol 1997;27: 143-149.