Randomized crossover study to assess the inter- and intrasubject variability of morning mycophenolic acid concentrations from enteric-coated mycophenolate sodium and mycophenolate mofetil in stable renal transplant recipients
Tedesco-Silva, Helio [UNIFESP]
Felipe, Claudia R. [UNIFESP]
Park, Sung I. [UNIFESP]
Pinheiro-Machado, Paula G. [UNIFESP]
Garcia, Riberto [UNIFESP]
Medina-Pestana, Jose O. [UNIFESP]
Is part ofClinical Transplantation
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The delayed release of mycophenolic acid (MPA) from enteric-coated mycophenolate sodium (EC-MPS, myfortic (R)) may have an impact on the variability of MPA trough (C(0 h)) levels. A randomized, two-period crossover study was performed in 24 maintenance renal transplants to evaluate the inter- and intrasubject variability of MPA predose levels from EC-MPS and mycophenolate mofetil (MMF, CellCept (R)), both in combination with cyclosporine. Patients received EC-MPS (720 mg b.i.d.) and MMF (1000 mg b.i.d.) for a period of 21 d each. MPA plasma levels were measured over the final seven consecutive days at -1, 0, 1, 2, and 3 h after the morning MPA dose. Intersubject coefficients of variation (%CV) for MPA troughs were 47.5% (95% CI, 34.1-80.3) and 54.4% (40.0-86.8) for EC-MPS and MMF, respectively; intrasubject %CVs were 62.7% (55.1-72.9) and 42.8% (37.9-49.2). High MPA C(0 h) levels > 10 mu g/mL were rarely observed with both EC-MPS (1.8%) and MMF (0.6%). Mean MPA area under the curve (AUC)(0-3 h) was comparable between treatments, while MPA C(0 h) was on average 46% higher with EC-MPS. in conclusion, predose MPA trough level monitoring appears of limited value during EC-MPS and MMF therapy given the large intrasubject variability in MPA C(0 h) levels with both treatments.
CitationClinical Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 24, n. 4, p. E116-E123, 2010.
Keywordsenteric-coated mycophenolate sodium
SponsorshipNovartis Pharma AG, Basel, Switzerland
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Population Pharmacokinetics of Mycophenolic Acid A Comparison between Enteric-Coated Mycophenolate Sodium and Mycophenolate Mofetil in Renal Transplant Recipients Winter, Brenda C. M. de; van Gelder, Teun; Glander, Petra; Cattaneo, Dario; Tedesco-Silva Junior, Hélio [UNIFESP]; Neumann, Irmgard; Hilbrands, Luuk; van Hest, Reinier M.; Pescovitz, Mark D.; Budde, Klemens; Mathot, Ron A. A. (Adis Int Ltd, 2008-01-01)Objective: the pharmacokinetics of mycophenolic acid (MPA) were compared in renal transplant patients receiving either mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS).Methods: MPA concentration-time ...
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