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Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients.
- Source :
-
Transplantation [Transplantation] 2000 Apr 15; Vol. 69 (7), pp. 1252-60. - Publication Year :
- 2000
-
Abstract
- Introduction: A previous trial in renal transplantation comparing sirolimus (rapamycin) to cyclosporine (CsA) in a 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.<br />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.<br />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.<br />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.
- Subjects :
- Acute Disease
Adolescent
Adult
Aged
Child
Cyclosporine administration & dosage
Cyclosporine adverse effects
Cyclosporine pharmacokinetics
Cyclosporine therapeutic use
Dose-Response Relationship, Drug
Drug Therapy, Combination
Female
Humans
Immunosuppressive Agents administration & dosage
Immunosuppressive Agents adverse effects
Immunosuppressive Agents pharmacokinetics
Male
Middle Aged
Mycophenolic Acid administration & dosage
Mycophenolic Acid adverse effects
Mycophenolic Acid pharmacokinetics
Mycophenolic Acid therapeutic use
Sirolimus administration & dosage
Sirolimus adverse effects
Sirolimus pharmacokinetics
Transplantation, Homologous
Graft Rejection prevention & control
Immunosuppressive Agents therapeutic use
Kidney Transplantation
Mycophenolic Acid analogs & derivatives
Sirolimus therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0041-1337
- Volume :
- 69
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 10798738
- Full Text :
- https://doi.org/10.1097/00007890-200004150-00009