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

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

Author Tedesco-Silva, Helio Autor UNIFESP Google Scholar
Felipe, Claudia R. Autor UNIFESP Google Scholar
Park, Sung I. Autor UNIFESP Google Scholar
Pinheiro-Machado, Paula G. Autor UNIFESP Google Scholar
Garcia, Riberto Autor UNIFESP Google Scholar
Slade, Alan Google Scholar
Schmouder, Robert Google Scholar
Medina-Pestana, Jose O. Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Novartis Pharmaceut
Abstract 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.
Keywords enteric-coated mycophenolate sodium
mycophenolate mofetil
mycophenolic acid
predose level
renal transplantation
variability
Language English
Sponsor Novartis Pharma AG, Basel, Switzerland
Date 2010-07-01
Published in Clinical Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 24, n. 4, p. E116-E123, 2010.
ISSN 0902-0063 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent E116-E123
Origin http://dx.doi.org/10.1111/j.1399-0012.2009.01183.x
Access rights Closed access
Type Article
Web of Science ID WOS:000280991700006
URI http://repositorio.unifesp.br/handle/11600/32703

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