Prospective observational study of sirolimus as primary immunosuppression after renal transplantation.
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Prospective observational study of sirolimus as primary immunosuppression after renal transplantation. / Pescovitz, Mark D; Nezakatgoo, Nosratollah; Lorber, Marc I; Nashan, Björn; Tedesco-Silva, Helio; Kasiske, Bertram L; Cruz, de La; Juarez, Federico J; Russ, Graeme; Campistol, Joseph; Keown, Paul A.
In: TRANSPLANTATION, Vol. 88, No. 8, 8, 2009, p. 1010-1018.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Prospective observational study of sirolimus as primary immunosuppression after renal transplantation.
AU - Pescovitz, Mark D
AU - Nezakatgoo, Nosratollah
AU - Lorber, Marc I
AU - Nashan, Björn
AU - Tedesco-Silva, Helio
AU - Kasiske, Bertram L
AU - Cruz, de La
AU - Juarez, Federico J
AU - Russ, Graeme
AU - Campistol, Joseph
AU - Keown, Paul A
PY - 2009
Y1 - 2009
N2 - BACKGROUND.: Sirolimus (SRL) is an important component of clinical immunosuppression in renal transplantation, but few international studies have examined how this agent is used in routine practice. METHODS.: Within a large prospective pharmacoepidemiological study, 718 de novo renal graft recipients treated with SRL in 65 centers in 10 countries were monitored for up to 5 years posttransplant to compare the principal outcomes and adverse effects by treatment regimen. RESULTS.: Principal treatment regimens were SRL without a calcineurin inhibitor (33%), SRL+cyclosporine A (CsA) (33%), and SRL+tacrolimus (TAC) (34%); 18% of subjects discontinued SRL, 124/718 (17%) developed biopsy-confirmed acute rejection (BCAR), 64/718 (9%) lost their graft, and 50/718 (7%) died during follow-up. Calculated creatinine clearance was 66+/-26 mL/min at 2 years. The most common adverse events were hypertension, hyperlipidemia, anemia, urinary tract infections, and diabetes. BCAR was significantly lower in subjects receiving SRL+TAC (hazard ratio [HR] 0.46, P=0.009) but not significantly lower in those receiving SRL+CsA (HR 0.62, P=0.102) compared with SRL without a calcineurin inhibitor. Graft loss or death did not significantly differ between treatment groups but were associated, respectively, with deceased donor grafts (HR 3.33, P
AB - BACKGROUND.: Sirolimus (SRL) is an important component of clinical immunosuppression in renal transplantation, but few international studies have examined how this agent is used in routine practice. METHODS.: Within a large prospective pharmacoepidemiological study, 718 de novo renal graft recipients treated with SRL in 65 centers in 10 countries were monitored for up to 5 years posttransplant to compare the principal outcomes and adverse effects by treatment regimen. RESULTS.: Principal treatment regimens were SRL without a calcineurin inhibitor (33%), SRL+cyclosporine A (CsA) (33%), and SRL+tacrolimus (TAC) (34%); 18% of subjects discontinued SRL, 124/718 (17%) developed biopsy-confirmed acute rejection (BCAR), 64/718 (9%) lost their graft, and 50/718 (7%) died during follow-up. Calculated creatinine clearance was 66+/-26 mL/min at 2 years. The most common adverse events were hypertension, hyperlipidemia, anemia, urinary tract infections, and diabetes. BCAR was significantly lower in subjects receiving SRL+TAC (hazard ratio [HR] 0.46, P=0.009) but not significantly lower in those receiving SRL+CsA (HR 0.62, P=0.102) compared with SRL without a calcineurin inhibitor. Graft loss or death did not significantly differ between treatment groups but were associated, respectively, with deceased donor grafts (HR 3.33, P
M3 - SCORING: Zeitschriftenaufsatz
VL - 88
SP - 1010
EP - 1018
JO - TRANSPLANTATION
JF - TRANSPLANTATION
SN - 0041-1337
IS - 8
M1 - 8
ER -
