Extended-release tacrolimus therapy in de novo kidney transplant recipients: single-center experience.
BACKGROUND
Available data for extended-release tacrolimus (Tac) except in clinical trials are limited.


OBJECTIVE
To describe our initial experience with once-daily Tac in combination with corticosteroids and mycophenolate mofetil therapy in patients undergoing de novo renal transplantation.


METHODS
In this retrospective, observational, single-center study, data were obtained for 49 adult recipients treated with extended-release Tac and 30 patients treated with standard-release Tac (control group). Mean (SD) follow-up in the 2 groups was 3.5 (2.5) months and 4.0 (2.6) months, respectively. The primary characteristics were comparable between the groups.


RESULTS
The acute rejection rate in the extended-release group was 10%, and 13% in the standard-release group. Patient and graft survival rates were 98% and 96% vs 100% and 90%, respectively. Renal function in the 2 groups was comparable: serum creatinine concentration 1.3 (0.2) mg/dL vs 1.45 (0.4) mg/dL. At day 14 posttransplantation, Tac doses were 0.17 mg/kg/d vs 0.14 mg/kg/d, and blood concentrations were 9.0 ng/mL vs 14.0 ng/mL. In recipients older than 60 years, lower dosages of Tac resulted in blood concentrations similar to those in younger patients, with less variation in dosage.


CONCLUSIONS
Short-term experience with extended-release Tac therapy in de novo renal recipients confirms its efficacy and safety. Adjusting blood concentrations in the immediate posttransplantation period is less difficult with extended-release Tac compared with the twice-daily formulation.
Nephrology Department, Hospital 12 de Octubre, Madrid, Spain. aandres.hdoc@salud.madrid.org
A
A
Andrés
M
M
Delgado-Arranz
E
E
Morales
T
T
Dipalma
N
N
Polanco
E
E
Gutierrez-Solis
J M
JM
Morales
M
M
Praga
E
E
Gutierrez
E
E
Gonzalez
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D016030:Kidney Transplantation; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D012189:Retrospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000008:administration & dosage* / Q000627:therapeutic use
D000305:Adrenal Cortex Hormones; D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus