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

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dc.contributor.authorTedesco-Silva, Helio [UNIFESP]
dc.contributor.authorFelipe, Claudia R. [UNIFESP]
dc.contributor.authorPark, Sung I. [UNIFESP]
dc.contributor.authorPinheiro-Machado, Paula G. [UNIFESP]
dc.contributor.authorGarcia, Riberto [UNIFESP]
dc.contributor.authorSlade, Alan
dc.contributor.authorSchmouder, Robert
dc.contributor.authorMedina-Pestana, Jose O. [UNIFESP]
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionNovartis Pharmaceut
dc.date.accessioned2016-01-24T14:05:10Z
dc.date.available2016-01-24T14:05:10Z
dc.date.issued2010-07-01
dc.description.abstractThe 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.en
dc.description.affiliationUniversidade Federal de São Paulo, Hosp Rim & Hipertensao, BR-04038002 São Paulo, Brazil
dc.description.affiliationNovartis Pharmaceut, Dept Translat Med, E Hanover, NJ USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Hosp Rim & Hipertensao, BR-04038002 São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipNovartis Pharma AG, Basel, Switzerland
dc.format.extentE116-E123
dc.identifierhttp://dx.doi.org/10.1111/j.1399-0012.2009.01183.x
dc.identifier.citationClinical Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 24, n. 4, p. E116-E123, 2010.
dc.identifier.doi10.1111/j.1399-0012.2009.01183.x
dc.identifier.issn0902-0063
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/32703
dc.identifier.wosWOS:000280991700006
dc.language.isoeng
dc.publisherWiley-Blackwell
dc.relation.ispartofClinical Transplantation
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://olabout.wiley.com/WileyCDA/Section/id-406071.html
dc.subjectenteric-coated mycophenolate sodiumen
dc.subjectmycophenolate mofetilen
dc.subjectmycophenolic aciden
dc.subjectpredose levelen
dc.subjectrenal transplantationen
dc.subjectvariabilityen
dc.titleRandomized 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 recipientsen
dc.typeinfo:eu-repo/semantics/article
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