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Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus‐based immunosuppressive regimen
Author(s) -
Sampaio Edison L,
PinheiroMachado Paula G,
Garcia Riberto,
Felipe Claudia R,
Park Sung I,
Casarini Dulce E,
Moreira Silvia,
Franco Marcello F,
TedescoSilva Jr Helio,
MedinaPestana Jose O
Publication year - 2007
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2007.00756.x
Subject(s) - medicine , tacrolimus , sirolimus , urology , regimen , mycophenolic acid , gastroenterology , mycophenolate , creatinine , kidney transplantation , proteinuria , transplantation , immunosuppression , kidney
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.