Abstract
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.
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Adrenal Cortex Hormones / administration & dosage*
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Adrenal Cortex Hormones / pharmacokinetics
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal / pharmacokinetics
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Antibodies, Monoclonal, Humanized
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Daclizumab
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Dose-Response Relationship, Drug
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Drug Combinations
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Humans
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Immunoglobulin G / administration & dosage
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Immunosuppressive Agents / administration & dosage*
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Immunosuppressive Agents / pharmacokinetics
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Kidney Transplantation*
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Mycophenolic Acid / administration & dosage
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Mycophenolic Acid / pharmacokinetics
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Tacrolimus / administration & dosage*
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Tacrolimus / pharmacokinetics
Substances
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Adrenal Cortex Hormones
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Drug Combinations
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Immunoglobulin G
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Immunosuppressive Agents
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Daclizumab
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Mycophenolic Acid
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Tacrolimus