Improved Rejection Prophylaxis With an Initially Intensified Dosing Regimen of Enteric-Coated Mycophenolate Sodium in de Novo Renal Transplant Recipients

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dc.contributor.authorBudde, Klemens
dc.contributor.authorTedesco-Silva, Helio [UNIFESP]
dc.contributor.authorArns, Wolfgang
dc.contributor.authorShoker, Ahmed
dc.contributor.authorZeier, Martin
dc.contributor.authorKlinger, Marian
dc.contributor.authorRosales, Beatriz
dc.contributor.authorWalker, Rowan
dc.contributor.authorPrestele, Hans
dc.contributor.authorVaidya, Soniya
dc.contributor.authorKuypers, Dirk
dc.contributor.institutionCharite
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionTransplantat Zentrum
dc.contributor.institutionUniv Saskatchewan
dc.contributor.institutionUniv Heidelberg Hosp
dc.contributor.institutionMed Univ
dc.contributor.institutionFrente Rectorado LUZ
dc.contributor.institutionRoyal Melbourne Hosp
dc.contributor.institutionNovartis Pharma AG
dc.contributor.institutionNovartis Inst BioMed Res
dc.contributor.institutionUniv Hosp Leuven
dc.date.accessioned2016-01-24T14:17:06Z
dc.date.available2016-01-24T14:17:06Z
dc.date.issued2011-08-15
dc.description.abstractBackground. Approximately half of cyclosporine A-treated renal transplant recipients do not reach sufficient mycophenolic acid (MPA) exposure in the first weeks posttransplantation with standard MPA dosing regimens.Methods. Here, we present a prospectively planned meta-analysis of data from two 6-month parallel-run studies that evaluated the effect of an initially intensified versus standard dosing regimen of enteric-coated mycophenolate sodium (EC-MPS). Four hundred forty-one de novo renal transplant recipients were randomized (1:1) to intensified (2 weeks 2880 mg/d; subsequently 4 weeks 2160 mg/d; followed by 1440 mg/d) or standard (1440 mg/d) EC-MPS, with con-comitant cyclosporine A treatment and steroids with or without anti-IL-2R induction. Primary endpoint was treatment failure (biopsy-proven acute rejection [BPAR], graft loss, or death) at month 6 posttransplantation.Results. Treatment failure rates were 17.4% in intensified and 22.4% in standard groups (P=0.110). the incidence of BPAR was 13.8% (intensified) vs. 19.3% (standard; P=0.034). A total of 80.5% (intensified) versus 39.0% (standard) of patients achieved 12 hr MPA-area under the curve more than 30 mu g.hr/mL as early as day 3 posttransplant. Renal function, gastrointestinal symptom rating scores, and safety profiles were comparable between treatment groups.Conclusion. the initially intensified EC-MPS dosing regimen was associated with higher MPA exposure, significantly lower rate of BPAR, and comparable safety. However, the intensified regimen did not affect graft function or survival.en
dc.description.affiliationCharite, Dept Nephrol, D-10117 Berlin, Germany
dc.description.affiliationUniversidade Federal de São Paulo, Hosp Rime Hipertensao, Div Nephrol, São Paulo, Brazil
dc.description.affiliationTransplantat Zentrum, Koeln Merheim, Germany
dc.description.affiliationUniv Saskatchewan, Dept Med, Div Nephrol, Saskatoon, SK S7N 0W0, Canada
dc.description.affiliationUniv Heidelberg Hosp, Dept Nephrol, Heidelberg, Germany
dc.description.affiliationMed Univ, Dept Nephrol & Transplantat Med, Wroclaw, Poland
dc.description.affiliationFrente Rectorado LUZ, Hosp Univ Maracaibo, Maracaibo, Venezuela
dc.description.affiliationRoyal Melbourne Hosp, Renal Unit, Melbourne, Vic, Australia
dc.description.affiliationNovartis Pharma AG, Basel, Switzerland
dc.description.affiliationNovartis Inst BioMed Res, Cambridge, MA USA
dc.description.affiliationUniv Hosp Leuven, Dept Nephrol & Renal Transplantat, Louvain, Belgium
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Hosp Rime Hipertensao, Div Nephrol, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipNovartis
dc.format.extent321-327
dc.identifierhttp://dx.doi.org/10.1097/TP.0b013e318223d7f3
dc.identifier.citationTransplantation. Philadelphia: Lippincott Williams & Wilkins, v. 92, n. 3, p. 321-327, 2011.
dc.identifier.doi10.1097/TP.0b013e318223d7f3
dc.identifier.issn0041-1337
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/33960
dc.identifier.wosWOS:000293176300015
dc.language.isoeng
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofTransplantation
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectIntensified enteric-coated mycophenolate sodium dosingen
dc.subjectRenal transplantationen
dc.subjectGraft lossen
dc.subjectMycophenolate mofetilen
dc.titleImproved Rejection Prophylaxis With an Initially Intensified Dosing Regimen of Enteric-Coated Mycophenolate Sodium in de Novo Renal Transplant Recipientsen
dc.typeinfo:eu-repo/semantics/article
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