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Pharmacokinetics of once- versus twice-daily tacrolimus formulations in kidney transplant patients receiving expanded criteria deceased donor organs: a single-center, randomized study.

Author(s): Cabello M, Garcia P, Gonzalez-Molina M, Diez de los Rios MJ, Garcia-Saiz M, Gutierrez C, Lopez V, Sola E, Burgos D, Hernandez D

Affiliation(s): Nephrology, Services of Carlos Haya University Hospital, Malaga, Spain.

Publication date & source: 2010-10, Transplant Proc., 42(8):3038-40.

Publication type: Randomized Controlled Trial

BACKGROUND: Noncompliance to immunosuppressive treatment is 1 of the risk factors for kidney graft loss. The once-daily, prolonged-release tacrolimus formulation may improve treatment adherence. We sought to compare the pharmacokinetics of both tacrolimus formulations in older de novo recipients of a cadaveric renal transplant from an expanded-criteria donor. PATIENTS AND METHODS: This randomized study included 27 patients (14 on once daily prolonged-release formulation [QD] and 13, on the twice-daily formulation [BID]), who were treated with 0.1 mg/kg per day of tacrolimus (target blood level, 5-8 ng/mL) mycophenolate mofetil prednisone and basiliximab induction. RESULTS: At 24 hours, in combination with the blood levels were 4.70+/-2.50 versus 4.70+/-3.04 ng/mL (P=NS). There were no significant differences in the AUC0-24 of tacrolimus (QD/BID) at 3 days (300.8+/-60.15 vs 287.7+/-125.78 ng.h/mL) or 21 days (303.05+/-99.79 vs 275.26+/-75.37 ng.h/mL), nor in blood levels (ng/mL) at 1 month (8.76+/-2.46 vs 8.8+/-1.89), 3 months (7.30+/-1.72 vs 8.80+/-1.89) and 6 months (7.19+/-1.89 vs 6.60+/-1.71). At 3 days, there was a strong correlation between AUC0-24 and Cmin both for tacrolimus QD (r=.872) and BID (r = 1.0). The incidences of acute rejection episodes were: 0% versus 16.6%; graft survivals, 100% versus 92.3% (P=NS); and patient survivals, both 100%. CONCLUSION: For older de novo recipients of kidneys from expanded criteria donors tacrolimus QD is comparable to the same dose in the BID formulation with similar at least short-term transplant outcomes. Copyright (c) 2010 Elsevier Inc. All rights reserved.

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