Consensus-recommendations for sirolimus in liver transplantation;Konsensusempfehlung zum einsatz von sirolimus in der lebertransplantation

Zeitschrift fur Gastroenterologie

Volumn 42, Issue 11, 2004, Pages 1333-1340

  Golling, M ^a   Becker, T ^b   Broelsch, C ^c   Candinas, D ^d   Faust, D ^e   Fischer, L ^f   Geissler, E ^g   Graeb, C ^h   Iberer, F ⁱ   Klupp, J ^j   Kraus, T ^k   Muller A R ^l   Neuhaus, P ^j   Strassburg, C P ^b   Wolff, M ^m   Zulke C ^g   Bechstein, Wolf Otto ^a  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c UNIVERSITY HOSPITAL ESSEN   (Germany)

^d UNIVERSITY OF BERN   (Switzerland)

^e GOETHE UNIVERSITY   (Germany)

^f UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^g UNIVERSITY HOSPITAL REGENSBURG   (Germany)

^h LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

ⁱ UNIVERSITY HOSPITAL GRAZ   (Austria)

^j CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^k UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^l UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^m UNIVERSITY HOSPITAL BONN   (Germany)

more..

Author keywords

Consensus conference; Liver transplantation; Sirolimus

Indexed keywords

RAPAMYCIN;

ANEMIA; ARTICLE; CANCER PREVENTION; CONSENSUS; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG INDICATION; DRUG INFORMATION; EVIDENCE BASED MEDICINE; GERMANY; GRAFT VERSUS HOST REACTION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; INTERSTITIAL PNEUMONIA; KIDNEY DISEASE; LIVER TRANSPLANTATION; MEDICAL LITERATURE; MOUTH ULCER; MUSCLE HYPERTONIA; NEPHROTOXICITY; NEUROTOXICITY; SIDE EFFECT; THROMBOCYTOPENIA;

DRUG THERAPY, COMBINATION; EVIDENCE-BASED MEDICINE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER TRANSPLANTATION; PRACTICE GUIDELINES; SIROLIMUS; TREATMENT OUTCOME;

EID: 10644281334     PISSN: 00442771     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2004-813703     Document Type: Article

References (66)

1. Sehgal SN. Rapamune (RAPA, rapamycin, sirolimus): mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem 1998; 31 (5): 335-340
2. Johnson RW, Kreis H, Oberbauer R et al. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation 2001; 72 (5): 777-786
3. Oberbauer R, Kreis H, Johnson RW et al for Rapamune Maintenance Regimen Study Group. Long-term improvement in renal function with sirolimus after early cyclosporine withdrawal in renal transplant recipients: 2-year results of the Rapamune Maintenance Regimen Study. Transplantation 2003; 76 (2): 364-370
4. Flechner SM, Goldfarb D, Modlin C et al. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation 2002; 74 (8): 1070-1076
5. Mota A, Arias M, Taskinen El et al. for the Rapamune Maintenance Regimen Trial. Sirolimus-based therapy following early cyclosporine withdrawal provides significantly improved renal histology and function at 3 years. Am J Transplant 2004; 4 (6): 953-961
6. Cuba M, von Breitenbuch P, Steinbauer M et al. Rapamycin inhibits primary and metastatic tumor growth by antangiogenesis: involvement of vascular endothelial groth factor. Nature Medicine 2002; 8 (2): 128-135
7. Wiesner R, Klintmalm G, McDiarmid S et al. for the Rapamune Liver Transplant Study Group. Sirolimus immunotherapy results in reduced rates of acute rejection in de novo orthotopic liver transplant recipients [abstract). Am J Transpl 2002; 2 (suppl 3): 464 (Abstract 1294)
8. Wiesner R for the Rapamune Liver Transplant Study Group. The safety and efficacy of Sirolimus and Cyclosporine versus Tacrolimus in de novo orthotopic liver transplant recipients: results from a pilot study. Hepatology 2001; 34: AASLD Abstracts 254 A; 321
9. Fachinformation Rapamune, Wyeth Europa Ltd. Huntercombe Lane SouthTaplow, Maidenhead Berkshire, SL6 OPH, Vereinigtes Königreich
10. Kneteman NM, Al-Saghier M, Meeberg GA et al. Targeted Immunosuppression for liver transplantation with pre-existing malignancy. ESOT 2003; Abstract Nr. 305
11. Chang GJ, Mahanty HD, Quan D et al. Experience with the use of sirolimus in liver trans-plantation - use in patients for whom calcineurin inhibitors are contraindicated. Liver Transpl 2000; 6 (6): 734-740
12. McAlister VC, Gao Z, Peltekian K et al. Sirolimus-tacrolimus combination immunosuppression. Lancet 2000; 355 (9201): 376-377
13. Trotter JF, Wachs M, Bak T et al. Liver transplantation using sirolimus and minimal corticosteroids (3-day taper). Liver Transpl 2001; 7 (4): 343-351
14. Pridöhl O, Heinemann K, Hartwig T et al. Low-dose immunosuppression with FK 506 and sirolimus after liver transplantation: 1-year results. Transplant Proc 2001; 33 (7-8): 3229-3231
15. MacDonald AS. Rapamycin in combination with cyclosporine or tacrolimus in liver, pancreas, and kidney transplantation. Transplant Proc 2003; 35 (3 Suppl): 201S-208S
16. Dunkelberg JC, Trotter JF, Wachs M et al. Sirolimus as primary immunosuppression in liver transplantation is not associated with hepatic artery or wound complications. Liver Transpl 2003; 9 (5): 463-468
17. Debray D, Furlan V, Baudouin V et al. Therapy for acute rejection in pediatric organ transplant recipients. Paediatr Drugs 2003; 5 (2): 81-89
18. Velidedeoglu E, Bloom RD, Crawford MD et al. Early kidney dysfunction post liver transplanta-tation predicts late chronic kidney disease. Transplantation 2004; 77 (4): 553-556
19. Ziolkowski J, Paczek L, Senatorski G et al. Renal function after liver transplantation: calcineurin inhibitor nephrotoxicity. Transplant Proc 2003; 35 (6): 2307-2309
20. Nankivell BJ, Borrows RJ, Fung CL et al. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349 (24): 2326-2333
21. Arns W. Consensus-statement zur Umstellung nierentransplantierter Patienten auf Rapamune®. J Nephrol Team 2 - 2004:17-21
22. Ojo AO, Held PJ, Port FK et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med 2003; 349 (10): 931-940
23. Cotterell AH, Fisher RA, King AL et al. Calcineurin inhibitor-induced chronic nephrotoxicity in liver transplant patients is reversible using rapamycin as the primary immunosuppressive agent. Clin Transplant 2002; 16 (Suppl 7): 49-51
24. Fairbanks KD, Eustace JA, Fine D et al. Renal function improves in liver transplant recipients when switched from a calcineurin inhibitor to sirolimus. Liver Transpl 2003; 9 (10): 1079-1085
25. Groth CG, Backman L, Morales JM et al. for the Sirolimus European Renal Transplant Study Group. Sirolimus (rapamycin)-based therapy in human liver transplantation: similar efficacy and different toxicity compared with cyclosporine. Transplantation 199967:1036-1042
26. Heffron TG, Smallwood GA, Davis L et al. Sirolimus-based immunosuppressive [correction of immunosuppresive] protocol for calcineurin sparing in liver transplantation. Transplant Proc 2002; 34 (5): 1522-1523
27. Kniepeiss D, Iberer F, Grasser B et al. Sirolimus in patients after liver transplantation. Transplant Proc 2003; 35 (2): 815-816
28. Nair S, Eason J, Loss G. Sirolimus monotherapy in nephrotoxicity due to calcineurin inhibitors in liver transplant recipients. Liver Transpl 2003; 9 (2): 126-129
29. Neff GW, Montalbano M, Tzakis AG. Ten years of sirolimus therapy in orthotopic liver transplant recipients. Transplant Proc 2003; 35 (3 Suppl): 209S-216S
30. Neff GW, Montalbano M, Slapak-Green G et al. Sirolimus therapy in orthotopic liver transplant recipients with calcineurin inhibitor related chronic renal insufficiency. Transplant Proc 2003; 35 (8): 3029-3031
31. Witzigmann H. Konversion auf Sirolimus-Monotherapie wegen Calcineurin-inhibitor induzierter Nephrotoxizität bei Patienten nach Lebertransplantation - Eine prospektive Beobachtungsstudie. Abstracts on CD. DTG 2003
32. Wramner L, Norden G, Herlenius G et al. Conversion to sirolimus after kidney and liver transplantation: indications and outcomes. Transplant Proc 2003; 35 (2): 791
33. Shenoy S, Hardinger KL, Lowell J et al. Interim analysis of a prospective randomised trial to assess reversal of early stage calcineurin inhibitor induced nephrotoxicity using sirolimus based immunosuppression in stable long term liver recipients. ATC 2004; Abstract Nr. [1595]
34. Watson CJ, Graeme JA, Allison ME et al. Superior renal function following conversion to sirolimus after liver transplantation - Preliminary results from a randomised trial. ATC 2004; Abstract Nr. [1596]
35. Pappas PA, Weppler D, Pinna AD et al. Sirolimus in pediatric gastrointestinal transplantation: the use of sirolimus for pediatric transplant patients with tacrolimus-related cardiomyopathy. Pediatr Transplant 2000; 4 (1): 45-49
36. Trotter JF. Sirolimus in liver transplantation. Transplant Proc 2003; 35 (3 Suppl): 193S-200S
37. Hojo M, Morimoto T, Maluccio M et al. Cyclosporine induces cancer progression by a cell-autonomous mechanism. Nature 1999; 397 (6719): 530-534
38. Maluccio M, Sharma V, Lagman M et al. Tacrolimus enhances transforming growth factor-beta1 expression and promotes tumor progression. Transplantation 2003; 76 (3): 597-602
39. Cuba M, Graeb C, Jauch KW et al. Pro- and anti-cancer effects of immunosuppressive agents used in organ transplantation. Transplantation 2004; 77 (12): 1777-1782
40. Kasiske BL, Snyder JJ, Gilbertson DT et al. Cancer after kidney transplantation in the United States. Am J Transplant 2004; 4 (6): 905-913
41. Chapman JR, Webster AC. Cancer after renal transplantation: the next challenge. Am J Transplant 2004; 4 (6): 841-842
42. Schumacher G, Oidtmann M, Rosewicz S et al. Sirolimus inhibits growth of human hepatoma cells in contrast to tacrolimus which promotes cell growth. Transplant Proc 2002; 34 (5): 1392-1393
43. Luan FL, Hojo M, Maluccio M et al. Rapamycin blocks tumor progression: unlinking immuno-suppression from antitumor efficacy. Transplantation 2002; 73 (10): 1565-1572
44. Mathew T, Kreis H, Friend P et al. Two-year incidence of malignancy in sirolimus-treated renal transplant recipients: results from five multicenter studies. Clin Transplant 2004; 18: 446-449
45. Kauffman HM, Cherikh WS, Cheng Y et al. Maintenance immunosuppression with tor inhibitors is associated with a reduced incidence of de novo malignancies. ATC 2004; Abstract Nr. [505]
46. Campistol JM, Gutierrez-Dalmau A, Torregrosa JV. Conversion to sirolimus: a successful treatment for posttransplantation Kaposi's sarcoma. Transplantation 2004; 77 (5): 760-762
47. Iglesias J, Ortega J, Lopez JA et al. Rapamycin-based rescue therapy after chronic rejection in a pediatric liver transplant patient. Transpl Int 2003; 16 (10): 765-767
48. Neff GW, Montalbano M, Slapak-Green G et al. A retrospective review of sirolimus (Rapamune) therapy in orthotopic liver transplant recipients diagnosed with chronic rejection. Liver Transpl 2003; 9 (5): 477-483
49. Nishida S, Pinna A, Verzaro R. Sirolimus (rapamycin)-based rescue treatment following chronic rejection after liver transplantation. Transplant Proc 2001; 33 (1-2): 1495
50. Zhu J, Wu J, Frizell E et al. Rapamycin inhibits hepatic stellate cell proliferation in vitro and limits fibrogenesis in an in vivo model of liver fibrosis. Gastroenterology 1999; 117 (5): 1198-1204
51. Friedman SL. The virtuosity of hepatic stellate cells. Gastroenterology 1999; 117 (5): 1244-1246
52. Fung J, Marcos A. Rapamycin: friend, foe, or misunderstood? Liver Transpl 2003; 9 (5): 469-472
53. Fortin MC, Raymond MA, Madore F et al. Increased risk of thrombotic microangiopathy in patients receiving a cyclosporin-sirolimus combination. Am J Transplant 2004; 4 (6): 946-952
54. Guilbeau JM. Delayed wound healing with sirolimus after liver transplant. Ann Pharmacother 2002; 36 (9): 1391-1395
55. Mathis AS. Comment: delayed wound healing with sirolimus after liver transplant. Ann Pharmacother 2003; 37 (3): 453
56. McAlister VC, Peltekian KM, Malatjalian DA et al. Orthotopic liver transplantation using low-dose tacrolimus and sirolimus. Liver Transpl 2001; 7 (8): 701-708
57. Avitzur Y, Jimenez-Rivera C, Fecteau A et al. Interstitial Granulomatous Pneumonitis associated with Sirolimus in a Child after Liver Transplantation. J Pediatr Gastroenterol Nutr 2003; 37 (1): 91-94
58. Lennon A, Finan K, FitzGerald MX et al. Interstitial pneumonitis associated with sirolimus (rapamycin) therapy after liver transplantation. Transplantation 2001; 72 (6): 1166-1167
59. Morelon E, Stern M, Israel-Biet D et al. Characteristics of sirolimus-associated interstitial pneumonitis in renal transplant patients. Transplantation 2001; 72 (5): 787-790
60. Haydar AA, Denton M, West A et al. Sirolimus-induced pneumonitis: three cases and a review of the literature. Am J Transplant 2004; 4 (1): 137-139
61. Trotter JF, Wachs ME, Trouillot TE et al. Dyslipidemia during sirolimus therapy in liver transplant recipients occurs with concomitant cyclosporine but not tacrolimus. Liver Transpl 2001; 7 (5): 401-408
62. Firpi RJ, Tran TT, Flores P et al. Sirolimus-induced hyperlipidaemia in liver transplant recipients is not dose-dependent. Aliment Pharmacol Ther 2004; 19 (9): 1033-1039
63. Maheshwari A, Mishra R, Thuluvath PJ. Post-liver-transplant anemia: etiology and management. Liver Transpl 2004; 10 (2): 165-173
64. Kaptik SR, Osborne JC, Trotter JF. Liver transplantation recipients without hepatitis C receiving sirolimus as primary immunosuppression have mild elevation in ALT. ATC 2004; Abstract Nr. [772]
65. Jain AK, Venkataramanan R, Fridell JA et al. Nelfinavir, a protease inhibitor, increases sirolimus levels in a liver transplantation patient: a case report. Liver Transpl 2002; 8 (9): 838-840
66. Fridell JA, Jain AK, Patel K et al. Phenytoin decreases the blood concentrations of sirolimus in a liver transplant recipient: a case report. Ther Drug Monit 2003; 25 (1): 117-119