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Randomized open‐label crossover assessment of Prograf vs Advagraf on immunosuppressant pharmacokinetics and pharmacodynamics in simultaneous pancreas‐kidney patients
Author(s) -
Cattral Mark,
Luke Sean,
Knauer Michael J.,
Norgate Andrea,
Schiff Jeffrey,
Muirhead Norman,
Luke Patrick P.
Publication year - 2018
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.13180
Subject(s) - medicine , tacrolimus , mycophenolic acid , pharmacokinetics , pharmacodynamics , crossover study , urology , anesthesia , pharmacology , surgery , transplantation , pathology , alternative medicine , placebo
We assessed the pharmacokinetic and pharmacodynamic impact of converting stable simultaneous pancreas‐kidney ( SPK ) recipients from standard tacrolimus (Prograf) to long‐acting tacrolimus (Advagraf). Methods In a randomized prospective crossover study, stable SPK recipients on Prograf were assigned to Prograf with 1:1 conversion to Advagraf or vice versa. Demographics, tacrolimus, mycophenolic acid levels, and Cylex CD 4 + ATP levels were taken at specified intervals in addition to standard blood work. Results Twenty‐one patients, who were a minimum of 1 year post‐transplant, were entered into the study. No difference in tacrolimus or mycophenolic acid levels was noted between patients who were first assigned to Prograf or Advagraf. Additionally, Cylex levels as well as serum creatinine, lipase, and blood sugar levels were unchanged. There were no episodes of rejection during the 6‐month study. Conclusions It is safe to convert between Prograf and Advagraf 1:1, without major impact on pharmacokinetics or pharmacodynamics in SPK recipients.