title: Race and drug formulation influence on mycophenolic acid pharmacokinetics in stable renal transplant recipients.
abstract: BACKGROUND
  Limited mycophenolic acid (MPA) data are available comparing racial influence on mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) pharmacokinetics.
  
  
  METHODS
  Intrapatient MPA pharmacokinetics of MMF versus EC-MPS were compared in 13 male African American (AA) and 14 Caucasian (C) renal transplant recipients (RTRs). RTRs were switched to equivalent doses of the alternate formulation for at least 10 days prior to the second study. Mycophenolic acid clearance and dose-normalized area under the concentration-time curve(0-12)  (AUC*) were determined. Mixed model statistics evaluated the main effects of race, drug formulation, and interaction of race and drug formulation (R × D) with albumin, cyclosporine trough, renal function, and diabetes and enterhepatic recirculation.
  
  
  RESULTS
  Significant R × D was identified for MPA AUC* for EC-MPS (AA, 0.056 ± 0.029 [mg·h/L]/mg; C, 0.080 ± 0.044 [mg·h/L]/mg) compared with MMF (AA, 0.053 ± 0.019 [mg·h/L]/mg; C, 0.060 ± 0.025 [mg·h/L]/mg), P = .022. Significant R × D was identified with albumin in the model for MPA clearance for MMF (AA, 21.7 ± 8.9 L/h; C, 20.5 ± 10.8 L/h) compared with EC-MPS (AA, 22.2 ± 10.1 L/h; C, 16.2 ± 9.1 L/h), P = .032.
  
  
  CONCLUSIONS
  Race influences MPA exposure between MMF and EC-MPS and may warrant therapeutic monitoring during formulation conversion.
authors: Pharmacotherapy Research Center, Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA. Tornator@buffalo.edu
authors: Kathleen M
authors: KM
authors: Tornatore
authors: Patcharaporn
authors: P
authors: Sudchada
authors: Kris
authors: K
authors: Attwood
authors: Gregory E
authors: GE
authors: Wilding
authors: Aijaz C
authors: AC
authors: Gundroo
authors: Robin
authors: R
authors: DiFrancesco
authors: Vanessa
authors: V
authors: Gray
authors: Rocco C
authors: RC
authors: Venuto
mesh_terms: D000328:Adult; D001741:Black or African American; D002626:Chemistry, Pharmaceutical; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013608:Tablets, Enteric-Coated; D044465:White People
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid