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Title: Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen
Authors: Sampaio, Edison L. [UNIFESP]
Pinheiro-Machado, Paula G. [UNIFESP]
Garcia, Riberto [UNIFESP]
Felipe, Claudia R. [UNIFESP]
Park, Sung I. [UNIFESP]
Casarini, Dulce E. [UNIFESP]
Moreira, Silvia [UNIFESP]
Franco, Marcello F. [UNIFESP]
Tedesco-Silva, Helio [UNIFESP]
Medina-Pestana, Jose O. [UNIFESP]
Universidade Federal de São Paulo (UNIFESP)
Keywords: acute allograft rejection
kidney transplantation
mycophenolate mofetil
randomized trial
Issue Date: 1-Mar-2008
Publisher: Blackwell Publishing
Citation: Clinical Transplantation. Oxford: Blackwell Publishing, v. 22, n. 2, p. 141-149, 2008.
Abstract: Mycophenolate mofetil (MMF) and sirolimus (SRL) are effective immunosuppressive drugs with distinct safety profile.Methods: Kidney transplant recipients receiving tacrolimus (TAC)-based immunosuppressive regimen were randomized to receive fixed daily doses of MMF (2 g/d, n = 50) or SRL (one loading dose of 15 mg, 5 mg/d till day 7 and 2 mg/d thereafter, n = 50) without induction therapy.Results: No differences were observed in the incidence of the composite (biopsy-confirmed acute rejection, graft loss or death) end-point (18% vs. 16%, p = 1.000), biopsy confirmed acute rejection (12% vs. 14%, p = 1.000), one-yr patient (94% vs. 98%, p = 0.308), graft (92% vs. 98%, p = 0.168), and death-censored graft survival (98% vs. 100%, p = 0.317) comparing patients receiving MMF or SRL respectively. Patients receiving SRL showed worse safety outcomes, higher mean creatinine (1.6 +/- 0.5 mg/dL vs. 1.4 +/- 0.3 mg/dL, p = 0.007), higher proportion of patients with proteinuria (52.0% vs. 10.7%, p = 0.041), higher mean urinary protein concentrations (0.3 +/- 0.5 g/L vs. 0.1 +/- 0.2 g/L, p = 0.012), higher mean cholesterol concentration (217 mg/dL vs. 190 mg/dL, p = 0.030), and higher proportion of patients prematurely discontinued from randomized therapy (26% vs. 8%, p = 0.031).Conclusion: in patients receiving TAC, MMF produced similar efficacy but superior safety profile compared with SRL.
ISSN: 0902-0063
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