Triple therapy with ursodeoxycholic acid, prednisone and azathioprine in primary biliary cirrhosis: A 1-year randomized, placebo-controlled study

Journal of Hepatology

Volumn 29, Issue 5, 1998, Pages 736-742

  Wolfhagen, Frank H J ^a   Van Hoogstraten, Hubert J F ^a   Van Buuren, Henk R ^a   Van Berge Henegouwen, Gerard P ^b   Ten Kate, Fiebo J W ^c   Hop, Wim C J ^d   Van Der Hoek, Egbert W ^e   Kerbert, Marjo J ^f   Van Lijf, Hans H ^f   Den Ouden, Janny W ^g   Smit, Adelbert M ^e   De Vries, Richard A ^h   Van Zanten, Rene A A ⁱ   Schalm, Solko W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^e JEROEN BOSCH HOSPITAL   (Netherlands)

^f Medical School Twente   (Netherlands)

^g SINT FRANCISCUS GASTHUIS   (Netherlands)

^h Rinjstate Hospital   (Netherlands)

ⁱ TWENTEBORG HOSPITAL   (Netherlands)

Author keywords

Azathioprine; Prednisone; Primary biliary cirrhosis; Ursodeoxycholic acid

Indexed keywords

AZATHIOPRINE; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; ETIDRONIC ACID; PLACEBO; PREDNISONE; URSODEOXYCHOLIC ACID;

ARTICLE; AUTOIMMUNE DISEASE; BACTERIAL PERITONITIS; BONE MASS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFECT; FEMALE; HISTOPATHOLOGY; HUMAN; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; MALAISE; MALE; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; WEIGHT GAIN;

EID: 0032213475     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-8278(98)80254-7     Document Type: Article

References (38)

1. Heathcote EJ, Lindor KD, Poupon R, Cauch-Dudek K, Dickson ER, Trout R, et al. Combined analysis of French, American and Canadian randomized trials of ursodeoxycholic acid in primary biliary cirrhosis [abstract]. Gastroenterology. 108:1995;A1082.
2. Lindor KD, Therneau TM, Jorgensen RA, Malinchoc M, Dickson ER. Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis. Gastroenterology. 110:1996;1515-1518.
3. Wolfhagen FH, van Buuren HR, Schalm SW, Kate FJW, ten Hattum J van, Eskens FA, et al. Can ursodeoxycholic acid induce disease remission in primary biliary cirrhosis? The dutch Multicentre PBC Study Group. J Hepatol. 22:1995;381.
4. Kaplan MM. Primary biliary cirrhosis - a first step in prolonging survival. N Engl J Med. 330:1994;1386-1387.
5. Beukers R, Schalm SW. Immunosuppressive therapy for primary biliary cirrhosis. J Hepatol. 14:1992;1-6.
6. Wolfhagen FH, van Buuren HR, Schalm SW. Combined treatment with ursodeoxycholic acid and prednisone in primary biliary cirrhosis. Neth J Med. 44:1994;84-90.
7. Leuschner M, Guldutuna S, You T, Hubner K, Bhatti S, Leuschner U. Ursodeoxycholic acid and prednisone versus ursodeoxycholic acid and placebo in the treatment of early stages of primary biliary cirrhosis. J Hepatol. 25:1996;49-57.
8. Mitchinson HC, Palmer JM. Bassendine trial of prednisolone treatment in primary biliary cirrhosis. Three-year results. J Hepatol. 15:1992;336-344.
9. Heathcote J, Ross A, Sherlock S. A prospective controlled trial of azathioprine in primary biliary cirrhosis. Gastroenterology. 70:1976;656-660.
10. Christensen E, Neuberger J, Crowe J, Altman DG, Popper H, Portmann B, et al. Beneficial effect of azathioprine and prediction of prognosis in primary biliary cirrhosis. Final results of an international trial. Gastroenterology. 89:1985;1084-1091.
11. Long RG, Meinhard E, Skinner RK, Varghese Z, Wills MR, Sherlock S. Clinical, biochemical, and histological studies of osteomalacia, osteoporosis, and parathyroid function in chronic liver disease. Gut. 19:1978;85-90.
12. Van Berkum FN, Beukers R, Birkenhager JC, Kooij PP, Schalm SW, Pols HA. Bone mass in women with primary biliary cirrhosis: the relation with histological stage and use of glucocorticoids. Gastroenterology. 99:1990;1134-1139.
13. Reid IR, King AR, Alexander CJ, Ibbertson HK. Prevention of steroid-induced osteoporosis with (3-amino-1-hydroxypropylidene)-1, 1-bisphosphonate (APD). Lancet. i:1988;143-146.
14. Mulder H, Struys A. Intermittent cyclical etidronate in the prevention of corticosteroid-induced bone loss. Br J Rheumatol. 33:1994;348-350.
15. Adachi JD, Bensen WG, Brown J, Hanley D, Hodsman A, Josse R, et al. Intermittent etidronate therapy to prevent corticosteroid-induced osteoporosis. N Engl J Med. 337:1997;382-387.
16. Singh G, Fries JF, Spitz P, William CA. Toxic effects of azathioprine in rheumatoid arthritis. A national post-marketing perspective. Arthritis Rheum. 32:1989;837-843.
17. Wang KK, Czaja AJ, Beaver SJ, Go VL. Extrahepatic malignancy following long-term immunosuppressive therapy of severe hepatitis B surface antigen-negative chronic active hepatitis. Hepatology. 10:1989;39-43.
18. Taal BG, Schalm SW, ten Kate FW, Hermans J, Geertzen RG, Feltkamp BE. Clinical diagnosis of primary biliary cirrhosis: a classification based on major and minor criteria. Hepatogastroenterology. 30:1983;178-182.
19. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding aesophageal varices. Br J Surg. 60:1973;646.
20. Wolfhagen FHJ, van Buuren HR, den Ouden JW, Hop WCJ, Leeuwen JPTM van, Schalm SW, et al. Cyclical etidronate in the prevention of bone loss in corticosteroid-treated primary biliary cirrhosis. J Hepatol. 26:1997;325-330.
21. Ludwig J, Dickson ER, McDonald GS. Staging of chronic nonsuppurative destructive cholangitis (syndrome of primary biliary cirrhosis). Virchows Arch A Pathol Anat Histol. 379:1978;103-112.
22. Ishak K, Baptista A, Bianchi L, Callea F, Groote J de, Gudat F, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 22:1995;696-699.
23. Attili AF, Rusticali A, Varriale M, Carli L, Repice AM, Callea F. The effect of ursodeoxycholic acid on serum enzymes and liver histology in patients with chronic active hepatitis. A 12-month double-blind, placebo-controlled trial. J Hepatol. 20:1994;315-320.
24. Growe J, Christensen E, Smith M, Cochrane M, Ranek L, Watkinson G, et al. Azathioprine in primary biliary cirrhosis: a preliminary report of an international trial. Gastroenterology. 78:1980;1005-1010.
25. Frei A, Zimmermann A, Weigand K. The N-terminal propeptide of collagen type III in serum reflects activity and degree of fibrosis in patients with chronic liver disease. Hepatology. 4:1984;830-844.
26. Eriksson S, Zettervall O. The N-terminal propeptide of collagen type III in serum as a prognostic indicator in primary biliary cirrhosis. Hepatol. 2:1986;370-378.
27. Babbs C, Smith A, Hunt LP, Rowan BP, Haboubi NY, Warnes TW. Type III procollagen peptide: a marker of disease activity and prognosis in primary biliary cirrhosis. Lancet. i:1988;1021-1024.
28. Poupon RE, Balkau B, Guechot J, Heintzmann F. Predictive factors in ursodeoxycholic acid-treated patients with primary billiary cirrhosis: role of serum markers of connective tissue. Hepatology. 19:1994;635-640.
29. Mutimer DJ, Bassendine MF, Kelly P, OF James. Is measurement of type III procollagen amino propeptide useful in primary biliary cirrhosis. J Hepatol. 9:1989;184-189.
30. Floreani A, Zappala F, Mazzetto M, Naccarato R, Plebani M, Chiaramonte M. Different response to ursodeoxycholic acid (UDCA) in primary biliary cirrhosis according to severity of disease. Dig Dis Sci. 39:1994;9-14.
31. Mitchison HC, Bassendine MF, Malcolm AJ, Watson AJ, Record CO, James OF. A pilot, double-blind, controlled 1-year trial of prednisolone treatment in primary biliary cirrhosis: hepatic improvement but greater bone loss. Hepatology. 10:1989;420-429.
32. Raedsch R, Stiehl A, Walker S, Scherrmann JM, Kommerell B. Kombinierte Ursodeoxycholasaure plus Colchizin-Behandlung bei primar biliarer Zirrhose: Ergebnise einer Placebokontrollierten Doppelblindstudie. Z Gastroenterol. 1:1992;55-57.
33. Goddard C, Hunt L, Smith A, Fallowfield G, Rowan B, Warnes T. A trial of ursodeoxycholic acid (UDCA) and colchicine in primary biliary cirrhosis (PBC) [abstracts]. Hepatology. 20:1994;151A.
34. Poupon RE, Huet PM, Poupon R, Bonnand A, Tran Van Nieu J, Zafrani ES. A randomized trial comparing colchicine and ursodeoxycholic acid to ursodeoxycholic acid in primary biliary cirrhosis. Hepatology. 24:1996;1098-1103.
35. Buscher HP, Zietzschmann Y, Gerok W. Positive responses to methotrexate and ursodeoxycholic acid in patients with primary biliary cirrhosis responding insufficiently to ursodeoxycholic acid alone. J Hepatol. 18:1993;9-14.
36. Van Steenbergen W, Sciot R, Vann Eyken P, Desmet V, Fevery J. Combined treatmnet with methotrexate and ursodeoxycholic acid in non-cirrhotic primary biliary cirrhosis. Acta Clin Belg. 51:1996;8-18.
37. 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. 22:1995;1158-1162.
38. Sharma A, Provenzale D, McKusick A, Kaplan MM. Interstitial pneumonitis after low-dose methotrexate therapy in primary biliary cirrhosis. Gastroenterology. 107:1994;266-270.