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Expert Opinion on Drug Safety Volume 8, 2009 - Issue 4
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Reviews

Considerations in sirolimus use in the early and late post-transplant periods

Samir J Patel The Methodist Hospital, Department of Pharmacy, 6565 Fannin St. MB1-056, Houston, TX 77030, USA [email protected]
,
Erin N Elliott The Methodist Hospital, Department of Pharmacy, 6565 Fannin St. MB1-056, Houston, TX 77030, USA [email protected]
,
Richard J Knight The Methodist Hospital, Department of Pathology, 6565 Fannin St. Suite M227, Houston, TX 77030, USA
,
Lillian W Gaber The Methodist Hospital, Department of Surgery, 6550 Fannin, Suite 1601 Smith Tower, Houston, TX 77030, USA
&
A Osama Gaber The Methodist Hospital, Department of Pathology, 6565 Fannin St. Suite M227, Houston, TX 77030, USA
, MD FACS
Pages 421-434 | Published online: 13 Jun 2009

Bibliography

  • Meier-Kriesche H, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite marked decrease in acute rejection rates over the most recent era. Am J Transplant 2004;4:378-83
  • Sehgal SN, Baker H, Vezina C. Rapamycin (AY-22,989) a new antifungal antibiotic. II. Fermentation, isolation and characterization. J Antibiot 1975;28:727-32
  • Sehgal SN. Rapamune® (RAPA, rapamycin, sirolimus): mechanism of action immunnuosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem 1998;31:335-40
  • Brattstrom C, Sawe J, Tyden G, et al. Kinetics and dynamics of single oral doses of sirolimus in sixteen renal transplant recipients. Ther Drug Monit 1997;19(4):397-406
  • MacDonald AS, RAPAMUNE Global Study Group. A worldwide, phase III, randomized, controlled, safety and efficacy study of a sirolimus/cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts. Transplantation 2001;71:271-80
  • Kahan BD, RAPAMUNE US Study Group. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a ramdonised multicentre study. Lancet 2000;356:194-202
  • Mendez R, Gonwa T, Yang HC, et al. A prospective, randomized trial of tacrolimus in combination with sirolimus or mycophenolate mofetil in kidney transplantation: results at 1 year. Transplantation 2005;80:303-9
  • Lo A, Egidi MF, Gaber LW, et al. Observations regarding the use of sirolimus and tacrolimus in high-risk cadaveric renal transplantation. Clin Transplant 2004;18:53-61
  • Gaber AO, Kahan BD, Van Buren C, et al. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation 2008;86:1187-95
  • Guba M, von Breitenbuch P, Steinbauer M, et al. Rapamycin inhibits primary and metastatic tumor growth by antiangiogenesis: involvement of vascular endothelial growth factor. Nat Med 2002;8(2):128-35
  • Campistol JM, Eris J, Oberbauer R, et al. Sirolimus therapy after early cyclosporine withdrawal reduces the risk for cancer in adult renal transplantation. J Am Soc Nephrol 2006;17(2):581-9
  • Kauffman HM, Cherikh WS, Cheng Y, et al. Maintenance immunosuppression with target-of-rapamycin inhibitors is associated with a reduced incidence of de novo malignancies. Transplantation 2005;80(7):883-9
  • Kuypers DR. Benefit-risk assessment of sirolimus in renal transplantation. Drug Saf 2005;28(2):153-81
  • Meier-Kriesche H-U, Steffen BJ, Chu AH, et al. Sirolimus with Neoral versus mycophenolate mofetil with Neoral is associated with decreased renal allograft survival. Am J Transplant 2004;4:2058-66
  • Meier-Kriesche H-U, Schold JD, Srinivas TR, et al. Sirolimus in combination with tacrolimus is associated with worse renal allograft survival compared to mycophenolate mofetil combined with tacrolimus. Am J Transplant 2005;5:2273-80
  • Vitko S, Wlodarczyk Z, Kyllönen L, et al. Tacrolimus combined with two different dosages of sirolimus in kidney transplantation: results of a multicenter study. Am J Transplant 2006;6(3):531-8
  • Kumar A, Heifets M, Fyfe B, et al. Comparison of steroid avoidance in tacrolimus/mycophenolate mofetil and tacrolimus/sirolimus combination in kidney transplantation monitored by surveillance biopsy. Transplantation 2005;80:807-14
  • Gallon L, Perico N, Dimitrov BD, et al. Long-term renal allograft function on a tacrolimus-based, pred-free maintenance immunosuppression comparing sirolimus vs. MMF. Am J Transplant 2006;6:1617-23
  • Oberbauer R, Segonloni G, Campistol JM, et al. Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transplant Int 2005;18:22-8
  • Flechner SM, Goldfarb D, Modlin C, et al. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized randomized trial of sirolimus versus cyclosporine. Transplantation 2002;74:1070-6
  • Flechner SM, Kurian SM, Solez K, et al. De novo kidney transplantation without use of calcineurin inhibitors preserve renal structure and function at two years. Am J Transplant 2004;4:1776-85
  • Flechner SM, Goldfarb D, Solez K, et al. Kidney transplantation with sirolimus and mycophenolate mofetil-based immunosuppression: 5-year results of a randomized prospective trial compared to calcineurin inhibitor drugs. Transplantation 2007;83:883-92
  • Larson TS, Dean PG, Stegall MD, et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant 2006;6:514-22
  • Hamdy AF, El-Agroudy AE, Bakr MA, et al. Comparison of sirolimus with low-dose tacrolimus versus sirolimus-based calcineurin inhibitor-free regimen in live donor renal transplantation. Am J Transplant 2005;5(10):2531-8
  • Hamdy AF, Bakr MA, Ghoneim MA. Long-term efficacy and safety of a calcineurin inhibitor-free regimen in live-donor renal transplant recipients. J Am Soc Nephrol 2008;19(6):1225-32
  • Lo A, Egidi MF, Gaber LW, et al. Comparison of sirolimus-based calcineurin inhibitor-sparing and calcineurin inhibitor-free regimens in cadaveric renal transplantation. Transplantation 2004;77:1228-35
  • Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007;375:2562-75
  • Srinivas TR, Schold JD, Guerra G, et al. Mycophenolate mofetil/sirolimus compared to other common immunosuppressive regimens in kidney transplantation. Am J Transplant 2007;7:586-94
  • Knight RJ, Kerman RH, Zela S, et al. Pancreas transplantation utilizing thymoglobulin, sirolimus, and cyclosporine. Transplantation 2006;81(8):1101-5
  • Hricik DE, Augustine JJ, Knauss TC, et al. Long-term graft outcomes after steroid withdrawal in African American kidney transplant recipients receiving sirolimus and tacrolimus. Transplantation 2007;83(3):277-81
  • Morelon E, Stern M, Israël-Biet D, et al. Characteristics of sirolimus-associated interstitial pneumonitis in renal transplant patients. Transplantation 2001;72(5):787-90
  • Knight RJ, Villa M, Laskey R, et al. Risk factors for impaired wound healing in sirolimus-treated renal transplant recipients. Clin Transplant 2007;21:460-5
  • Grim SA, Slover CM, Sankary H, et al. Risk factors for wound healing complications in sirolimus-treated renal transplant recipients. Transplant Proc 2006;38:3520-3
  • Tiong HY, Flechner SM, Zhou L, et al. A systemic approach to minimizing wound problems for de novo sirolimus-treated kidney transplant recipients. Transplantation 2009;87:296-302
  • Gaber MW, Aziz AM, Shang X, et al. Changes in abdominal wounds following treatment with sirolimus and steroids in a rat model. Transplant Proc 2006;38(10):3331-2
  • Sandrini S, Setti G, Bossini N, et al. Steroid withdrawal five days after renal transplantation allows for the prevention of wound-healing complications associated with sirolimus therapy. Clin Transplant 2009;23:16-22
  • Halloran PF, Hunsicker L. Delayed graft function: state of the art, November 10-11, 2000 Summit meeting, Scottsdale, Arizona, USA. Am J Transplant 2001;1:115
  • Patel SJ, Duhart BT, Krauss AG, et al. Risk factors and consequences of delayed graft function in deceased donor renal transplant patients receiving antithymocyte globulin induction. Transplantation 2008;86:313-20
  • McTaggert RA, Gottlieb D, Brooks J, et al. Sirolimus prolongs recovery from delayed graft function after cadaveric renal transplantation. Am J Transplant 2003;3:416-23
  • Boratynska M, Banasik M, Patrzalek D, et al. Sirolimus delays recovery from posttransplant renal failure in kidney graft recipients. Transplant Proc 2005;37:839-42
  • Smith KD, Wrenshall LE, Nicosia RF, et al. Delayed graft function and cast nephropathy associated with tacrolimus plus rapamycin use. J Am Soc Nephrol 2003;14:1037-45
  • Simon JF, Swanson SJ, Agodoa LYC, et al. Induction sirolimus and delayed graft function after deceased donor kidney transplantation in the United States. Am J Nephrol 2004;24:393-401
  • Citterlo F, Scata MC, Violi P, et al. Rapid conversion to sirolimus for chronic progressive deterioration of the renal function in kidney allograft recipients. Transplant Proc 2003;35:1292-94
  • Egidi MF, Cowan PA, Naseer A, Gaber AO. Conversion to sirolimus in solid organ transplantation: a single-center experience. Transplant Proc 2003;35(Suppl 3):131S-7S
  • Peddi VR, Jensik S, Pescovitz M, et al. An open-label, pilot study evaluating the safety and efficacy of converting from calcineurin inhibitors to sirolimus in established renal allograft recipients with moderate renal insufficiency. Clin Transplant 2005;19:130-6
  • Bumbea V, Kamar N, Ribes D, et al. Long-term results in renal transplant patients with allograft dysfunction after switching from calcineurin inhibitors to sirolimus. Nephrol Dial Transplant 2005;20:2517-23
  • Kamar N, Frimat L, Blancho G, et al. Evaluation of the efficacy and safety of a slow conversion from calcineurin inhibitor- to sirolimus-based therapies in maintenance renal-transplant patients presenting with moderate renal insufficiency. Transpl Int 2007;20:128-34
  • Diekmann F, Budde K, Oppenheimer F, et al. Predictors of success in conversion from calcineurin inhibitor to sirolimus in chronic allograft dysfunction. Am J Transplant 2004;4:1869-75
  • Diekmann F, Budde K, Slowinski T, et al. Conversion to sirolimus for chronic allograft dysfunction: long-term results confirm predictive value of proteinuria. Transpl Int 2008;21:152-5
  • Wali RK, Mohanlal V, Ramos E, et al. Early withdrawal of calcineurin inhibitors and rescue immunosuppression with sirolimus-based therapy in renal transplant recipients with moderate to severe renal dysfunction. Am J Transplant 2007;7:1572-83
  • Watson CJ, Firth J, Williams PF, et al. A randomized controlled trial of late conversion from CNI-based to sirolimus-based immunosuppression following renal transplantation. Am J Transplant 2005;5:2496-503
  • Stallone G, Infante B, Schena A, et al. Rapamycin for treatment of chronic allograft nephropathy in renal transplant patients. J Am Soc Nephrol 2005;16:3755-62
  • Schena FP, Pascoe MD, Alberu J, et al. Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation 2009;87:233-42
  • Mulay AV, Cockfield S, Stryker R, et al. Conversion from calcineurin inhibitors to sirolimus for chronic renal allograft dysfunction: a systematic review of the evidence. Transplantation 2006;82(9):1153-62
  • Pearson TC, Mulgaonkar S, Patel A, et al. Efficacy and safety of mycophenolate mofetil (MMF)/sirolimus (SRL) maintenance therapy after calcineurin inhibitor (CNI) withdrawal in renal transplant recipients: final results of the spare-the-nephron (STN) Trial [abstract #129]. Am J Transplant 2008;8(s2):213
  • Lebranchu Y, Thierry A, Toupance O, et al. Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: concept study. Am J Transplant 2009;9:1115-23
  • Dominguez J, Mahalati K, Kiberd B, et al. Conversion to rapamycin immunosuppression in renal transplant recipients: report of an initial experience. Transplantation 2000;70:1244-7
  • Saber LT, Ikeda MY, Almeida JM. Posttransplantation conversion to sirolimus-based immunosuppression: a single center experience. Transplant Proc 2007;39:3098-100
  • Ruiz JC, Campistol JM, Sánchez-Fructuoso A, et al. Increase of proteinuria after conversion from calcineurin inhibitor to sirolimus-based treatment in kidney transplant patients with chronic allograft dysfunction. Nephrol Dial Transplant 2006;21:3252-7
  • Letavernier E, Pe'raldi MN, Pariente A, et al. Proteinuria following a switch from calcineurin inhibitors to sirolimus. Transplantation 2005;80:1198-203
  • Mahé E, Morelon E, Lechaton S, et al. Cutaneous adverse events in renal transplant recipients receiving sirolimus-based therapy. Transplantation 2005;79:476-82
  • Abramowicz D, Hadaya K, Hazzan M. Conversion to sirolimus for chronic renal allograft dysfunction: risk factors for graft loss and severe side effects. Nephrol Dial Transplant 2008;23:3727-9
  • Mathew T, Kreis H, Friend P. Two-year incidence of malignancy in sirolimus-treated renal transplant recipients: results from five multicenter studies. Clin Transplant 2004;18(4):446-9
  • Kahan BD, Yakupoglu YK, Schoenberg L, et al. Low incidence of malignancy among sirolimus/cyclosporine-treated renal transplant recipients. Transplantation 2005;80:749-58
  • Boratyńska M, Watorek E, Smolska D, et al. Anticancer effect of sirolimus in renal allograft recipients with de novo malignancies. Transplant Proc 2007;39(9):2736-9
  • Stallone G, Schena A, Infante B, et al. Sirolimus for Kaposi's sarcoma in renal-transplant recipients. N Engl J Med 2005;352(13):1317-23
  • Campistol JM, Guitierrez-Dalmau A, Torregrosa JV. Conversion to sirolimus: a successful treatment for posttransplantation Kaposi's sarcoma. Transplantation 2004;77:760
  • Campistol JM, Albanell J, Arns W, et al. Use of proliferation signal inhibitors in the management of post-transplant malignancies–clinical guidance. Nephrol Dial Transplant 2007;22(Suppl 1):i36-41
  • Elloso MM, Azrolan N, Sehgal SN, et al. Protective effect of the immunosuppressant sirolimus against aortic atherosclerosis in apo E-deficient mice. Am J Transplant 2003;3(5):562-9
  • Basso MD, Nambi P, Adelman SJ. Effect of sirolimus on the cholesterol content of aortic arch in ApoE knockout mice. Transplant Proc 2003;35(8):3136-8
  • Pakala R, Stabile E, Jang GJ, et al. Rapamycin attenuates atherosclerotic plaque progression in apolipoprotein E knockout mice: inhibitory effect on monocyte chemotaxis. J Cardiovasc Pharmacol 2005;46(4):481-6
  • Raichlin E, Bae JH, Khalpey Z, et al. Conversion to sirolimus as primary immunosuppression attenuates the progression of allograft vasculopathy after cardiac transplantation. Circulation 2007;116(23):2726-33
  • Mancini D, Pinney S, Burkhoff D, et al. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation 2003;108(1):48-53

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