Ursodiol prophylaxis against hepatic complications of allogeneic bone marrow transplantation: A randomized, double-blind, placebo-controlled trial

Annals of Internal Medicine

Volumn 128, Issue 12 PART 1, 1998, Pages 975-981

  Essell, James H ^a,b   Schroeder, Mark T ^a,d   Harman, Glenn S ^a,e   Halvorson, Ronald ^a,f   Lew, Vernon ^a,d   Callander, Natalie ^a,g   Snyder, Michael ^a,h   Lewis, Stacey K ^a,d   Allerton, Jeffrey P ^a,d   Thompson, James M ^a,c  

^a WILFORD HALL MEDICAL CENTER   (United States)

^b Oncology Hematology Care Inc   (United States)

^c Indiana Blood and Marrow Transplantation   (United States)

^d Dubuque Internal Medicine ^*  (United States)

^e Dubuque Internal Medicine   (United States)

^f Dakota Midwest Cancer Institute   (United States)

^g University of Texas Health Science Center at San Antonio   (United States)

^h Missoula Oncol and Infect Disease   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; AMPHOTERICIN B; BUSULFAN; CYCLOSPORIN; METHOTREXATE; URSODEOXYCHOLIC ACID; VANCOMYCIN;

ADULT; ALLOGENIC BONE MARROW TRANSPLANTATION; ARTICLE; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE CONTROL; DOUBLE BLIND PROCEDURE; FEMALE; GRAFT VERSUS HOST REACTION; HUMAN; LIVER PROTECTION; LIVER VEIN OBSTRUCTION; MAJOR CLINICAL STUDY; MALE; MORTALITY; ORAL DRUG ADMINISTRATION; PATIENT CODING; PATIENT SELECTION; PILOT STUDY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE; TREATMENT INDICATION; TREATMENT OUTCOME;

EID: 17344386370     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-128-12_part_1-199806150-00002     Document Type: Article

References (37)

1. Bearman SI, Appelbaum FR, Buckner CD, Peterson FB, Fisher LD, Clift RA, et al. Regimen-related toxicity in patients undergoing bone marrow transplantation. J Clin Oncol. 1988;6:1562-8.
2. Rollins BJ. Hepatic veno-occlusive disease. Am J Med. 1986;81:297-306.
3. McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED. Venoocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology. 1984;4:116-22.
4. Atkinson K, Biggs J, Noble G, Ashby M, Concannon A, Dodds A. Preparative regimens for marrow transplantation containing busulfan are associated with haemorrhagic cystitis and hepatic veno-occlusive disease but a short duration of leucopenia and little oro-pharyngeal mucositis. Bone Marrow Transplant. 1987;2:385-94.
5. Essell JH, Thompson JM, Harman GS, Halvorson RD, Snyder MJ, Johnson RA, et al. Marked increase in veno-occlusive disease of the liver associated with methotrexate use for graft-versus-host disease prophylaxis in patients receiving busulfan/cyclophosphamide. Blood. 1992;79:2784-8.
6. Bearman SI, Shen DD, Hinds MS, Hill HA, McDonald GB. A phase I/II study of prostaglandin E1 for the prevention of hepatic veno-occlusive disease after bone marrow transplantation. Br J Haematol. 1993;84:724-30.
7. Attal M, Huguet F, Rubie H, Huynh A, Charlet JP, Payen JL, et al. Prevention of hepatic veno-occlusive disease after bone marrow transplantation by continuous infusion of low-dose heparin: a prospective, randomized trial. Blood. 1992;79:2834-40.
8. Gluckman E, Jolivet I, Scrobohaci ML, Devergie A, Trainequ R, Bourdeau-Esperou H, et al. Use of prostaglandin E1 for prevention of liver veno-occlusive disease in leukaemic patients treated by allogeneic bone marrow transplantation. Br J Haematol. 1990;74:277-81.
9. Bearman SI, Hinds MS, Wolford JL, Peterson FB, Nugent DC, Slichter SJ, et al. A pilot study of continuous infusion heparin for the prevention of hepatic veno-occlusive disease after bone marrow transplantation. Bone Marrow Transplant. 1990;5:407-11.
10. Ward A, Brogden RN, Heel RC, Speight TM, Avery GS. Ursodeoxycholic acid: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1984;27:95-131.
11. Bachrach WH, Hofmann AF. Ursodeoxcholic acid in the treatment of cholesterol cholilithiasis. Part I. Dig Dis Sci. 1982;27:737-61.
12. Parquet M, Metman EH, Raizman A, Rambaud JC, Berthaux N, Infante R. Bioavailability, gastrointestinal transit, solubilization and faecal excretion of ursodeoxycholic acid in man. Eur J Clin Invest. 1985;15:171-8.
13. Poupon RE, Balkau B, Eschwege E, Poupon R. A multicenter trial of ursodiol for the treatment of primary biliary cirrhosis. UDCA-PBC Study Group. N Engl J Med. 1991;324:1548-54.
14. Combes B, Carithers RL Jr, Maddrey WC, Lin D, McDonald MF, Wheeler DE, et al. A randomized, double-blind, placebo-controlled trial of ursodeoxycolic acid in primary biliary cirrhosis. Hepatology. 1995;22:759-66.
15. Lindor KD, Therneau TM, Jorgenscn RA, Malinchoc M, Dickson ER. Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis. Gastroenterology. 1996;110:1515-8.
16. Red Book. Montvale, NJ: Medical Economics; 1997.
17. Essell JH, Thompson JM, Harman GS, Halvorson RD, Snyder MJ, Callander NS, et al. Pilot trial of prophylactic ursodiol to decrease the incidence of veno-occlusive disease of the liver in allogeneic bone marrow transplant patients. Bone Marrow Transplant. 1992;10:367-72.
18. Podda M, Ghezzi C, Battezzati PM, Bertolini E, Crosignani A, Petroni ML, et al. Effect of different doses of ursodeoxycholic acid in chronic liver disease. Dig Dis Sci. 1989;34(12 Suppl):59S-65S.
19. Tutschka PJ, Copeland EA, Klein JP. Bone marrow transplantation for leukemia following a new busulfan and cydophosphamide regimen. Blood. 1987;70:1382-8.
20. Raybon K, Thomas A, Schroeder M, Lewis S, Christman K, Wilks S, et al. Bone marrow transplantation in multiple myeloma with busulfan and cyclophosphamide: unacceptable toxicity with standard dose in heavily pretreated patients [Abstract]. Blood. 1995;86(Suppl 1):961a.
21. Deeg JH, Spitzer TR, Cottler-Fox M, Cahill R, Pickle LW. Conditioning-related toxicity and acute graft-versus-host disease in patients given methotrexate/cyclosporine prophylaxis. Bone Marrow Transplant. 1991;7:193-8.
22. Schroeder M, Essell J, Harman G, Halvorson R, Dolan M, Callander N, et al. Directed ganciclovir prophylaxis against cytomegalovirus pneumonitis in patients undergoing allogeneic bone marrow transplantation [Abstract]. Blood. 1993;82(Suppl 1):425a.
23. Glucksberg H, Storb R, Fefer A, Buckner CD, Neiman PE, Clift RA, et al. Clinical manifestations of graft-versus-host disease in human recipients of marrow from HLA-matched sibling donors. Transplantation. 1974;18:295-304.
24. Matthews DE, Farewell VT. Using and Understanding Medical Statistics. 2d ed. New York: Karger; 1988.
25. Carreras E, Granena A, Navasa M, Bruguera M, Marco V, Sierra J, et al. On the reliability of clinical criteria for the diagnosis of hepatic venoocclusive disease. Ann Hematol. 1993;66:77-80.
26. Mehta J, Powles R, Horton C, Milan S, Singhal S, Treleaven J. Relationship between donor-recipient blood group incompatibility and serum bilirubin after allogeneic bone marrow transplantation from HLA-identical siblings. Bone Marrow Transplant. 1995;15:853-8.
27. Bearman SI. The syndrome of hepatic veno-occlusive disease after marrow transplantation. Blood. 1995;85:3005-20.
28. Rozman C, Carreras E, Qian C, Gale R, Bortin MM, Rowlings PA, et al. Risk factors for hepatic veno-occlusive disease following HLA-identical sibling bone marrow transplants for leukemia. Bone Marrow Transplant. 1996;17: 75-80.
29. Grochow LB, Jones RJ, Brundrett RB, Braine HG, Chen TL, Saral R, et al. Pharmacokinetics of busulfan: correlation with veno-occlusive disease in patients undergoing bone marrow transplantation. Cancer Chemother Pharmacol. 1989;25:55-61.
30. Schroeder M, Jaslowski A, Thomas A, Warren T, Lewis S, Essell J, et al. Busulfan pharmacokinetics in patients undergoing allogeneic bone marrow transplant: an analysis of the effects of ursodiol [Abstract]. Blood. 1996; 88(Suppl 1):259b.
31. Clift RA, Buckner CD, Thomas ED, Bensinger WI, Bowden R, Bryant E, et al. Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide. Blood. 1994;84:2036-43.
32. Batta AK, Salen G, Arora R, Shefer S, Tint GS, Abroon J, et al. Effect of ursodeoxycholic acid on bile acid metabolism in primary biliary cirrhosis. Hepatology. 1989;10:414-9.
33. Podda M, Ghezzi C, Battezzati PM, Bertolini E, Crosignani A, Petroni ML, et al. Ursodeoxycholic acid for chronic liver diseases. J Clin Gastroenterol. 1988;10(Suppl 2):S25-S31.
34. Chretien Y, Poupon R, Gherardt MF, Chazouilleres O, Labbe D, Myera A, et al. Bile acid glycine and taurine conjugates in serum of patients with primary biliary cirrhosis: effect of ursodeoxycholic treatment. Gut. 1989;30: 1110-5.
35. Podda M, Ghezzi C, Battezzati PM, Crosignani A, Zuin M, Roda A. Effects of ursodeoxycholic acid and taurine on serum liver enzymes and bile acids in chronic hepatitis. Gastroenterology. 1990;98:1044-50.
36. Guldutuna S, Zimmer G, lmhof M, Bhatti S, You T, Leuschner U. Molecular aspects of membrane stabilization by ursodeoxycholate. Gastroenterology. 1993;104:1736-44.
37. Bellentani S, Chao YC, Ferretti I, Panini R, Tiribelli C. Chronic administration of ursodeoxycholic and tauroursodeoxycholic acid changes microsomal membrane lipid content and fatty acid compositions in rats. Biochem Biophys Res Commun. 1996;220:479-83.