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Equivalent Pharmacokinetics of Mycophenolate Mofetil in African‐American and Caucasian Male and Female Stable Renal Allograft Recipients
Author(s) -
Pescovitz Mark D.,
Guasch Antonio,
Gaston Robert,
Rajagopalan P.,
Tomlanovich Stephen,
Weinstein Samuel,
Bumgardner Ginny L.,
Melton Larry,
Ducray Patricia Sanwald,
Banken Ludger,
Hall Joanna,
Boutouyrie Bruno X.
Publication year - 2003
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1046/j.1600-6135.2003.00243.x
Subject(s) - medicine , confidence interval , pharmacokinetics , mycophenolic acid , mycophenolate , cmax , dosing , urology , metabolite , transplantation
African‐American (AA) renal transplant recipients require higher doses of mycophenolate mofetil (MMF) than Caucasians. A hypothesized pharmacokinetic (PK) difference was tested in stable renal transplant recipients. Whole blood was collected before, and 20, 40 and 75 min, and 2, 3, 4, 6, 8 and 12 h after the MMF dose. Mycophenolic acid (MPA) and its glucuronide metabolite (MPAG) were analyzed using HPLC. Analysis of variance was performed for the primary end‐points of dose‐adjusted PK parameters AUC 0–12 and C max of MPA using log‐transformed values. Differences between races and genders were estimated: 90% confidence intervals (CI) were calculated. Back‐transformation gave estimates of the race and gender ratio and their CI. Equivalence of the groups was determined if the 90% confidence limits were included in the interval (0.80, 1.25). The calculated PK parameters were comparable among the four subgroups (Caucasian, AA, Male, Female). The 90% CIs for the ratio of dose‐adjusted AUC 0–12 of MPA between races were between 89.7 and 112.9%. There were no race, gender or race‐by‐gender effects (p‐values = 0.196) nor differences between diabetics and nondiabetics. This study demonstrates that dosing requirement for MMF in AA and Caucasians is unlikely to be related to different exposures to MPA .