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Everolimus plus mycophenolate mofetil as initial immunosuppression in liver transplantation.

Identifieur interne : 001066 ( PubMed/Curation ); précédent : 001065; suivant : 001067

Everolimus plus mycophenolate mofetil as initial immunosuppression in liver transplantation.

Auteurs : M. Jiménez-Pérez [Espagne] ; R. González Grande [Espagne] ; F J Rando Mu Oz [Espagne] ; J. De La Cruz Lombardo [Espagne] ; M A Mu Oz Suárez [Espagne] ; J L Fernández Aguilar [Espagne] ; J A Pérez Daga [Espagne] ; J. Santoyo-Santoyo [Espagne] ; R. Manteca González [Espagne] ; J M Rodrigo L Pez [Espagne]

Source :

RBID : pubmed:25645779

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Abstract

The purpose of this study was to assess the efficacy and safety of a de novo immunosuppressive regimen with everolimus (EVL) plus mycophenolate mofetil (MMF) without calcineurin inhibitors (CNI) for liver transplantation. The secondary purpose was to compare the renal function with a control group of patients treated with tacrolimus plus MMF.

DOI: 10.1016/j.transproceed.2014.11.005
PubMed: 25645779

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<term>Adult</term>
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<term>Carcinoma, Hepatocellular (surgery)</term>
<term>Drug Therapy, Combination</term>
<term>Everolimus</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Graft Rejection (prevention & control)</term>
<term>Humans</term>
<term>Immunosuppressive Agents (therapeutic use)</term>
<term>Liver Neoplasms (surgery)</term>
<term>Liver Transplantation</term>
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<term>Graft Rejection</term>
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<term>Carcinoma, Hepatocellular</term>
<term>Liver Neoplasms</term>
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<term>Acide mycophénolique</term>
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<term>Drug Therapy, Combination</term>
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<div type="abstract" xml:lang="en">The purpose of this study was to assess the efficacy and safety of a de novo immunosuppressive regimen with everolimus (EVL) plus mycophenolate mofetil (MMF) without calcineurin inhibitors (CNI) for liver transplantation. The secondary purpose was to compare the renal function with a control group of patients treated with tacrolimus plus MMF.</div>
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<DateCreated>
<Year>2015</Year>
<Month>02</Month>
<Day>03</Day>
</DateCreated>
<DateCompleted>
<Year>2015</Year>
<Month>10</Month>
<Day>29</Day>
</DateCompleted>
<DateRevised>
<Year>2016</Year>
<Month>11</Month>
<Day>25</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1873-2623</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>47</Volume>
<Issue>1</Issue>
<PubDate>
<MedlineDate>2015 Jan-Feb</MedlineDate>
</PubDate>
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<Title>Transplantation proceedings</Title>
<ISOAbbreviation>Transplant. Proc.</ISOAbbreviation>
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<ArticleTitle>Everolimus plus mycophenolate mofetil as initial immunosuppression in liver transplantation.</ArticleTitle>
<Pagination>
<MedlinePgn>90-2</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.transproceed.2014.11.005</ELocationID>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The purpose of this study was to assess the efficacy and safety of a de novo immunosuppressive regimen with everolimus (EVL) plus mycophenolate mofetil (MMF) without calcineurin inhibitors (CNI) for liver transplantation. The secondary purpose was to compare the renal function with a control group of patients treated with tacrolimus plus MMF.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Sixteen male and 4 female liver transplant patients received immunosuppression with EVL plus MMF without CNI, with induction with steroids and 16 with basiliximab also. In 10 cases it was indicated as induction immunosuppression without CNI as prevention against nephrotoxicity and neurotoxicity or recurrence of hepatocarcinoma in predisposed patients and in another 10 after withdrawing CNI during the immediate post-transplant period, before hospital discharge, as the result of toxicity, mainly nephrotoxicity and neurotoxicity or the presence of hepatocarcinoma with a high risk of recurrence. A control group comprising 31 patients taking tacrolimus plus MMF was included to compare the renal function.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The mean follow-up time was 24 months. One patient had a recurrence of hepatocarcinoma at 8 months after transplant. The cases of nephrotoxicity and neurotoxicity resolved favorably. There were 7 rejections (35%); 2 evolved to chronic rejection with both needing retransplantation, 2 resolved with dose adjustment, and 3 required conversion to CNI. The side effects were hyperlipidemia (25%), wound dehiscence (10%), lymphedema (10%), cytomegalovirus infection (25%), myelotoxicity (25%) and proteinuria >1 g in 1 case (5%). No differences were found in renal function between the two groups.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This regimen was proven to be efficient to prevent and treat nephrotoxicity and neurotoxicity with an acceptable tolerability profile. However, the high associated rejection rate indicates that great caution is required in its use during the immediate post-transplant period. It is advisable to associate the regimen with low doses of CNI and to have agile methods available to monitor EVL to enable rapid dose adjustment.</AbstractText>
<CopyrightInformation>Copyright © 2015 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<LastName>Jiménez-Pérez</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
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<Affiliation>Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain. Electronic address: mjimenezp@commalaga.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>González Grande</LastName>
<ForeName>R</ForeName>
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<AffiliationInfo>
<Affiliation>Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rando Muñoz</LastName>
<ForeName>F J</ForeName>
<Initials>FJ</Initials>
<AffiliationInfo>
<Affiliation>Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.</Affiliation>
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<LastName>Fernández Aguilar</LastName>
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