Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids.

Author(s): Hesselink DA, Ngyuen H, Wabbijn M, Gregoor PJ, Steyerberg EW, van Riemsdijk IC, Weimar W, van Gelder T

Affiliation(s): Department of Internal Medicine, Renal Transplant Unit, Room D 412, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, the Netherlands. d.a.hesselink@erasmusmc.nl

Publication date & source: 2003-09, Br J Clin Pharmacol., 56(3):327-30.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

AIMS: To evaluate the effect of corticosteroids on tacrolimus pharmacokinetics. METHODS: In a randomized trial, kidney transplant recipients were treated with tacrolimus and mycophenolate mofetil with either daclizumab (n = 31) or 3 months of prednisone (n = 34). Tacrolimus dose-adjusted predose concentrations (C0) at month 1-6 were compared between both groups and within the corticosteroid group before and after prednisone withdrawal. RESULTS: At month 1 the tacrolimus dose-adjusted C0 in the corticosteroid group was 83 +/- 8 vs 119 +/- 17 ng ml-1 mg-1 kg-1 in the daclizumab group. The tacrolimus dose-adjusted C0 within the corticosteroid group at month 1 and 2 was 42% and 29% lower compared with month 4 (P < 0.001). CONCLUSIONS: A higher tacrolimus dose is required to reach target concentrations when used in combination with corticosteroids.