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

• Published in: Clinical transplantation Vol. 22; no. 2; pp. 141 - 149
• Main Authors: Sampaio, Edison L, Pinheiro-Machado, Paula G, Garcia, Riberto, Felipe, Claudia R, Park, Sung I, Casarini, Dulce E, Moreira, Silvia, Franco, Marcello F, Tedesco-Silva Jr, Helio, Medina-Pestana, Jose O
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.03.2008; Blackwell
• Subjects: acute allograft rejection; Adrenal Cortex Hormones - therapeutic use; Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Drug Therapy, Combination; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Graft Rejection - immunology; Graft Rejection - prevention & control; Humans; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; kidney transplantation; Kidney Transplantation - immunology; Male; Medical sciences; Middle Aged; mycophenolate mofetil; Mycophenolic Acid - adverse effects; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Pharmacology. Drug treatments; Prospective Studies; randomized trial; safety; sirolimus; Sirolimus - adverse effects; Sirolimus - therapeutic use; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; tacrolimus; Tacrolimus - therapeutic use; Tissue, organ and graft immunology; Treatment Outcome; Antineoplastic agent; Mofetil; Graft(material); Mycophenolic acid; Calcineurin inhibitor; Sirolimus; Homograft; Homotransplantation; Kidney; Macrocycle; Randomization; Surgery; safety; Antiviral; Clinical trial; Protein synthesis inhibitor; Drug combination; Acute; randomized trial; Lactone; Macrolide; Recommendation; Immunomodulator; Rejection; Antibiotic; acute allograft rejection; Treatment; Urinary system; Tacrolimus; Application method; Immunosuppressive agent; Mycophenolate mofetil; Inosine monophosphate dehydrogenase inhibitor; Antibacterial agent; Therapeutic protocol; Comparative study; Kidney transplantation
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/j.1399-0012.2007.00756.x

:  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.