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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
11
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pubmed:dateCreated |
2007-10-11
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pubmed:abstractText |
Efficacy and safety of mycophenolate mofetil (MMF) may be optimized with individualized doses based on therapeutic monitoring of its active metabolite, mycophenolic acid (MPA). In this 12-month study, 137 renal allograft recipients from 11 French centers receiving basiliximab, cyclosporine A, MMF and corticosteroids were randomized to receive either concentration-controlled doses or fixed-dose MMF. A novel Bayesian estimator of MPA AUC based on three-point sampling was used to individualize doses on posttransplant days 7 and 14 and months 1, 3 and 6. The primary endpoint was treatment failure (death, graft loss, acute rejection and MMF discontinuation). Data from 65 patients/group were analyzed. At month 12, the concentration-controlled group had fewer treatment failures (p = 0.03) and acute rejection episodes (p = 0.01) with no differences in adverse event frequency. The MMF dose was higher in the concentration-controlled group at day 14 (p < 0.0001), month 1 (p < 0.0001) and month 3 (p < 0.01), as were median AUCs on day 14 (33.7 vs. 27.1 mg*h/L; p = 0.0001) and at month 1 (45.0 vs. 30.9 mg*h/L; p < 0.0001). Therapeutic MPA monitoring using a limited sampling strategy can reduce the risk of treatment failure and acute rejection in renal allograft recipients 12 months posttransplant with no increase in adverse events.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Nov
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pubmed:issn |
1600-6135
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pubmed:author |
pubmed-author:BüchlerMM,
pubmed-author:CaillardSS,
pubmed-author:EtienneII,
pubmed-author:Hurault de LignyBB,
pubmed-author:LavaudSS,
pubmed-author:Le MeurYY,
pubmed-author:MarquezVV,
pubmed-author:RérolleJ-PJP,
pubmed-author:RostaingLL,
pubmed-author:RousseauAA,
pubmed-author:SzelagJ CJC,
pubmed-author:ThervetEE,
pubmed-author:ThierryAA,
pubmed-author:TouchardGG,
pubmed-author:VillemainFF,
pubmed-author:WesteelP-FPF
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pubmed:issnType |
Print
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pubmed:volume |
7
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
2496-503
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pubmed:dateRevised |
2009-1-15
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pubmed:meshHeading |
pubmed-meshheading:17908276-Adrenal Cortex Hormones,
pubmed-meshheading:17908276-Antibodies, Monoclonal,
pubmed-meshheading:17908276-Area Under Curve,
pubmed-meshheading:17908276-Cyclosporine,
pubmed-meshheading:17908276-Dose-Response Relationship, Drug,
pubmed-meshheading:17908276-Drug Therapy, Combination,
pubmed-meshheading:17908276-Humans,
pubmed-meshheading:17908276-Immunosuppressive Agents,
pubmed-meshheading:17908276-Kidney Transplantation,
pubmed-meshheading:17908276-Mycophenolic Acid,
pubmed-meshheading:17908276-Recombinant Fusion Proteins,
pubmed-meshheading:17908276-Safety,
pubmed-meshheading:17908276-Transplantation, Homologous
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pubmed:year |
2007
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pubmed:articleTitle |
Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation.
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pubmed:affiliation |
Department of Nephrology, University Hospital, Limoges, France. yannick.lemeur@chu-brest.fr
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study
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