The combination of ursodeoxycholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone

Journal of Hepatology

Volumn 27, Issue 1, 1997, Pages 143-149

  González Koch, Alvaro ^a   Brahm, Javier ^a   Antezana, Cristina ^a   Smok, Gladys ^a   Cumsille, Miguel A ^b  

^a HOSPITAL CLÍNICO UNIVERSIDAD DE CHILE   (Chile)

^b UNIVERSITY OF CHILE   (Chile)

Author keywords

Methotrexate; Primary biliary cirrhosis; Ursodeoxycholic acid

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHOLESTEROL; GAMMA GLUTAMYLTRANSFERASE; IMMUNOGLOBULIN M; METHOTREXATE; URSODEOXYCHOLIC ACID;

ABDOMINAL DISCOMFORT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GLOSSITIS; HUMAN; LIVER BIOPSY; NAUSEA; ORAL DRUG ADMINISTRATION; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; VOMITING;

EID: 0343416897     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-8278(97)80294-2     Document Type: Article

References (28)

1. Poupon R, Poupon RE, Calmus Y, Chrétien Y, Ballet F, Darnis F. Is ursodeoxycholic acid an effective treatment for primary biliary cirrhosis? Lancet. i:1987;834-836.
2. Poupon RE, Balkau B, Eschwège E, Poupon R. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. N Engl J Med. 324:1991;1548-1554.
3. Poupon RE, Poupon R, Balkau B. Ursodiol for the long-term treatment of primary biliary cirrhosis. N Engl J Med. 330:1994;1342-1347.
4. Kaplan MM, Knox TA, Arora S. Primary biliary cirrhosis treated with low-dose oral pulse methotrexate. Ann Intern Med. 109:1988;429-431.
5. Kaplan MM. The Therapeutic effects of ursodiol and methotrexate are additive and well tolerated in primary biliary cirrhosis. Hepatology. 16:1992;92A. (Abstr).
6. Buscher H-P, 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.
7. 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.
8. Ludwig J, Dickson ER, McDonald GSA. Staging of chronic non-suppurative destructive cholangitis (syndrome of primary biliary cirrhosis). Virchows Arch Pathol Anat. 379:1978;103-112.
9. Portmann B, Popper H, Neuberger J, Williams R. Sequential and diagnostic features in primary biliary cirrhosis based on serial histologic study in 209 patients. Gastroenterology. 88:1985;1777-1790.
10. Dickson ER, Grambsch PM, Fleming TR, Fisher LD, Langworthy A. Prognosis in primary biliary cirrhosis: model for decision making. Hepatology. 10:1989;1-7.
11. Roll J, Boyer JL, Barry D, Klatskin G. The prognostic importance of clinical and histologic features in asymptomatic and symptomatic primary biliary cirrhosis. N Engl J Med. 308:1983;1-7.
12. Christensen E, Altman DG, Neuberger J, De Stavole BL, Tygstrup N, Williams R. Updating prognosis in primary biliary cirrhosis using a time-dependent Cox regression model. Gastroenterology. 105:1993;1865-1876.
13. Locke GR III, Therneau TM, Ludwig J, Dickson ER, Lindor KD. Time course of histological progression in primary biliary cirrhosis. Hepatology. 23:1996;52-56.
14. Wiesner RH, Grambsch PM, Lindor KD, Ludwig J, Dickson ER. Clinical and statistical analyses of new and evolving therapies for primary biliary cirrhosis. Hepatology. 8:1988;668-676.
15. Jones DEJ, James OFW, Bassendine MF. Ursodeoxycholic acid therapy in primary biliary cirrhosis. Hepatology. 21:1995;1469-1473.
16. Goddard CJR, Warnes TW. Primary biliary cirrhosis: how should we evaluate new treatments? (letter). Lancet. 343:1994;1305-1306.
17. Kaplan MM, Knox TA. Treatment of primary biliary cirrhosis with low-dose weekly methotrexate. Gastroenterology. 101:1991;1332-1338.
18. Findor JA, Linares C, Sordá JA, Podestá A, Abecasis R, Terg R. Comunicación preliminar del tratamiento a largo plazo con ácido ursodesoxicólico (UDCA) en la cirrosis biliar primaria. GEN. 46:1992;250. (Abstr).
19. 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.
20. Bellentani S, Podda M, Tiribelli C, Callea F, Marazzi M, Sodde M, et al. Ursodiol in the long-term treatment of chronic hepatitis: a double-blind multicenter clinical trial. J Hepatol. 19:1993;459-464.
21. Rolandi E, Franceschini R, Cataldi A, Cicchetti V, Carati L, Barreca T. Effects of ursodeoxycholic acid (UDCA) on serum liver damage indices in patients with chronic active hepatitis. A double-blind controlled study. Eur J Clin Pharmacol. 40:((5)):1991;473-476.
22. Crosignani A, Battezzati PM, Setchell KD, Camisasca M, Bertolini E, Roda A, et al. Effects of ursodeoxycholic acid on serum liver enzymes and bile acid metabolism in chronic active hepatitis: a dose-response study. Hepatology. 13:1991;339-344.
23. Leuschner M, Güldütuna S, You T, Hübner K, Bhatti S, Leuschner U. Ursodeoxycholic acid and prednisolone versus ursodeoxycholic acid and placebo in the treatment of early stages of primary biliary cirrhosis. J Hepatol. 25:1996;49-57.
24. Zachariae H, Sogaard H. Methotrexate-induced liver cirrhosis: a follow-up. Dermatologica. 175:1987;178-182.
25. Mackenzie AH. Hepatotoxicity of prolonged methotrexate therapy for rheumatoid arthritis. Cleve Clin Q. 52:1985;129-135.
26. Rau R, Karger T, Herborn G, Frenzel H. Liver biopsy findings in patients with rheumatoid arthritis undergoing long-term treatment with methotrexate. J Rheumatol. 16:1989;489-493.
27. Hoofnagle JH, Bergasa NV. Methotrexate therapy for primary biliary cirrhosis: promising but worrisome. Gastroenterology. 101:1991;1440-1442.
28. Sherlock S. Therapeutics trials in primary biliary cirrhosis. Q J Med. 87:1994;701-703.