Premium
Sirolimus Does Not Exhibit Nephrotoxicity Compared to Cyclosporine in Renal Transplant Recipients
Author(s) -
Morales José M.,
Wramner Lars,
Kreis Henri,
Durand Dominique,
Campistol Josep M.,
Andres Amado,
Arenas Joaquin,
Nègre Eric,
Burke James T.,
Groth Carl G.
Publication year - 2002
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1034/j.1600-6143.2002.20507.x
Subject(s) - sirolimus , medicine , urology , calcineurin , azathioprine , renal function , nephrotoxicity , everolimus , gastroenterology , ciclosporin , uric acid , creatinine , transplantation , pharmacology , kidney , disease
Sirolimus and cyclosporine (CsA) prevent acute rejection in man when used as primary therapies in triple drug regimens. Sirolimus does not act via the calcineurin pathway and therefore is not expected to produce the same renal side‐effects. This paper presents the pooled 2‐year data analysis of renal function parameters from two open‐label, randomized, multicenter studies. Patients (18–68 years) receiving a primary renal allograft were randomized to receive concentration‐controlled sirolimus (n = 81) or CsA (n = 80), in combination with azathioprine and steroids (n = 83), or mycophenolate mofetil (MMF) and steroids (n = 78). From week 10 through year 2, calculated glomerular filtration rate (GFR) was significantly higher in sirolimus‐ than in CsA‐treated patients (69.3 vs. 56.8 mL/min, at 2 years, p = 0.004). Serum uric acid was significantly higher in the CsA‐treated patients and magnesium was significantly lower; these parameters were more likely to be within normal limits in the sirolimus group. Mean serum potassium and phosphorus were lower in sirolimus‐treated patients. In conclusion, sirolimus, when administered as primary therapy in combination with azathioprine or MMF, has a favorable safety profile compared to CsA with regards to renal function.