Title
Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Philadelphia :Lippincott williams & wilkins ,
Subject
Human medicine
Source (journal)
Transplantation. - Baltimore, Md, 1963, currens
Source (book)
9th Congress of the European-Society-of-Organ-Transplantation, JUN 19-24, 1999, OSLO, NORWAY
Volume/pages
69(2000) :7 , p. 1252-1260
ISSN
0041-1337
ISI
000086681800010
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Abstract
Introduction. A previous trial in renal transplantation comparing sirolimus (rapamycin) to cyclosporine (CsA) ina triple-drug therapy regimen with azathioprine and corticosteroids found that the incidence of acute rejection was similar (approximately 40%) with a trend for better renal function with sirolimus. Methods. In 14 European centers, first cadaveric renal allograft recipients were randomized to receive sirolimus (n=40) or CsA (n=38) in an open-label design. All patients received corticosteroids and mycophenolate mofetil 2 g/day. Sirolimus and CsA were concentration controlled; trough levels of mycophenolic acid and prednisolone were also measured. Results. At 12 months, graft survival(92.5% sirolimus vs. 89.5% CsA), patient survival (97.5% sirolimus vs. 94.7% CsA), and the incidence of biopsy-proven acute rejection (27.5% sirolimus vs. 18.4% CsA) were not statistically different. The use of antibodies to treat suspected rejection episodes was also similar (7.5% sirolimus vs. 5.3% CsA). More sirolimus patients received bolus steroid therapy (20 vs. 11, P=0.068). From month 2 onward, the calculated glomerular filtration rate was consistently higher in sirolimus-treated patients. The adverse events reported more frequently with sirolimus were thrombocytopenia (45% vs. 8%) and diarrhea (38% vs. 11%). In the CsA group, increased creatinine (18% vs. 39%), hyperuricemia (3% vs. 18%), cytomegalovirus infection (5% vs. 21%), and tremor (5% vs. 21%) were observed significantly more often. Discussion. Patient and graft survival and the incidence of biopsy-proven acute rejection at 12 months were comparable between sirolimus and CsA, whereas safety profiles were different. These data suggest that sirolimus may be used as primary therapy for the prevention of acute rejection.
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