Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen

Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen

Author Sampaio, Edison L. Autor UNIFESP Google Scholar
Pinheiro-Machado, Paula G. Autor UNIFESP Google Scholar
Garcia, Riberto Autor UNIFESP Google Scholar
Felipe, Claudia R. Autor UNIFESP Google Scholar
Park, Sung I. Autor UNIFESP Google Scholar
Casarini, Dulce E. Autor UNIFESP Google Scholar
Moreira, Silvia Autor UNIFESP Google Scholar
Franco, Marcello F. Autor UNIFESP Google Scholar
Tedesco-Silva, Helio Autor UNIFESP Google Scholar
Medina-Pestana, Jose O. Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
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.
Keywords acute allograft rejection
kidney transplantation
mycophenolate mofetil
randomized trial
safety
sirolimus
tacrolimus
Language English
Date 2008-03-01
Published in Clinical Transplantation. Oxford: Blackwell Publishing, v. 22, n. 2, p. 141-149, 2008.
ISSN 0902-0063 (Sherpa/Romeo, impact factor)
Publisher Blackwell Publishing
Extent 141-149
Origin http://dx.doi.org/10.1111/j.1399-0012.2007.00756.x
Access rights Closed access
Type Article
Web of Science ID WOS:000253982000003
URI http://repositorio.unifesp.br/handle/11600/30523

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