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Sirolimus Versus Cyclosporine in Kidney Recipients Receiving Thymoglobulin ® , Mycophenolate Mofetil and a 6‐Month Course of Steroids
Author(s) -
Büchler M.,
Caillard S.,
Barbier S.,
Thervet E.,
Toupance O.,
Mazouz H.,
Hurault de Ligny B.,
Le Meur Y.,
Thierry A.,
Villemain F.,
Heng A.E.,
Moulin B.,
Morin M. P.,
Noël C.,
Lebranchu Y.
Publication year - 2007
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 - 10.1111/j.1600-6143.2007.01976.x
Subject(s) - medicine , sirolimus , urology , renal function , regimen , discontinuation , calcineurin , gastroenterology , adverse effect , immunosuppression , surgery , transplantation
To evaluate the efficacy and tolerance of a calcineurin inhibitor (CNI)‐free regimen, 145 renal recipients were prospectively randomized to receive either sirolimus (n = 71) or cyclosporine (CsA; n = 74). All patients received polyclonal antilymphocyte antibodies, mycophenolate mofetil (MMF) and steroids (6 months). The primary endpoint, estimated glomerular filtration rate (eGFR) was not significantly different at 12 months comparing sirolimus‐ and CsA‐treated patients (60 ± 27 vs. 57 ± 21 mL/min). At 12 months, patient and graft survival, incidence of biopsy‐proven rejection and rates of steroid withdrawal were not statistically different (97% vs. 97%; 90% vs. 93%; 14.3% vs. 8.6% and 82.8% vs. 84.1%, respectively). Delayed and slow graft function (SGF) was not significantly different (18.6% vs. 12.3% and 11.4% vs. 13.7%, respectively). In patients who remained on treatment according to protocol at 12 months, eGFR was significantly higher with sirolimus (69 ± 19 vs. 60 ± 14 mL/min, p = 0.01). Overall study drug discontinuation rates were 28.2% with sirolimus and 14.9% with CsA. Adverse events (wound complications, mouth ulcers, diarrhea, hypokalemia, bronchopneumonia) and proteinuria >0.5 g/24h (38.8% vs. 5.6%, p < 0.001) were significantly more frequent in sirolimus‐treated patients. Cytomegalovirus (CMV) infections were significantly less frequent with sirolimus (6% vs. 23%, p < 0.01). A CNI‐free regimen using sirolimus‐MMF can achieve excellent renal function, but patients on sirolimus experienced a high rate of adverse events and study drug discontinuation.