Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen
Version of Record online: 2 SEP 2007
© 2007 Blackwell Munksgaard
Volume 22, Issue 2, pages 141–149, March/April 2008
How to Cite
Sampaio, E. L., Pinheiro-Machado, P. G., Garcia, R., Felipe, C. R., Park, S. I., Casarini, D. E., Moreira, S., Franco, M. F., Tedesco-Silva Jr, H. and Medina-Pestana, J. O. (2008), Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen. Clinical Transplantation, 22: 141–149. doi: 10.1111/j.1399-0012.2007.00756.x
- Issue online: 2 SEP 2007
- Version of Record online: 2 SEP 2007
- Accepted for publication 11 July 2007
- acute allograft rejection;
- kidney transplantation;
- mycophenolate mofetil;
- randomized trial;
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.