RapamycinFungusV1, Main, Exploration, bibRecord, 000241

Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.

Identifieur interne : 000241 ( Main/Exploration ); précédent : 000240; suivant : 000242

Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.

Auteurs : Helio Tedesco-Silva [Brésil] ; Julio Pascual [Espagne] ; Ondrej Viklicky [République tchèque] ; Nikolina Basic-Jukic [Croatie] ; Elisabeth Cassuto [France] ; Dean Y. Kim [États-Unis] ; Josep M. Cruzado [Espagne] ; Claudia Sommerer [Allemagne] ; Mohamed Adel Bakr [Égypte] ; Valter D. Garcia [Brésil] ; Huynh-Do Uyen [Suisse] ; Graeme Russ [Australie] ; Myoung Soo Kim [Corée du Sud] ; Dirk Kuypers [Belgique] ; Matthias Buchler [France] ; Franco Citterio [Italie] ; Maria Pilar Hernandez Gutierrez [Suisse] ; Peter Bernhardt [Suisse] ; Steve Chadban [Australie]

Source :

Transplantation [ 1534-6080 ] ; 2019.

RBID : pubmed:30801548

Descripteurs français

KwdFr :
- Acide mycophénolique (administration et posologie), Adulte (MeSH), Adulte d'âge moyen (MeSH), Association de médicaments (MeSH), Ciclosporine (administration et posologie), Ciclosporine (effets indésirables), Facteurs de risque (MeSH), Facteurs temps (MeSH), Humains (MeSH), Immunosuppresseurs (administration et posologie), Immunosuppresseurs (effets indésirables), Inhibiteurs de la calcineurine (administration et posologie), Inhibiteurs de la calcineurine (effets indésirables), Rejet du greffon (immunologie), Rejet du greffon (mortalité), Rejet du greffon (prévention et contrôle), Résultat thérapeutique (MeSH), Survie du greffon (effets des médicaments et des substances chimiques), Tacrolimus (administration et posologie), Tacrolimus (effets indésirables), Transplantation rénale (effets indésirables), Transplantation rénale (mortalité), Évérolimus (administration et posologie), Évérolimus (effets indésirables).
MESH :
- administration et posologie : Acide mycophénolique, Ciclosporine, Immunosuppresseurs, Inhibiteurs de la calcineurine, Tacrolimus, Évérolimus.
- effets des médicaments et des substances chimiques : Survie du greffon.
- effets indésirables : Ciclosporine, Immunosuppresseurs, Inhibiteurs de la calcineurine, Tacrolimus, Transplantation rénale, Évérolimus.
- immunologie : Rejet du greffon.
- mortalité : Rejet du greffon, Transplantation rénale.
- prévention et contrôle : Rejet du greffon.
- Adulte, Adulte d'âge moyen, Association de médicaments, Facteurs de risque, Facteurs temps, Humains, Résultat thérapeutique.

English descriptors

KwdEn :
- Adult (MeSH), Calcineurin Inhibitors (administration & dosage), Calcineurin Inhibitors (adverse effects), Cyclosporine (administration & dosage), Cyclosporine (adverse effects), Drug Therapy, Combination (MeSH), Everolimus (administration & dosage), Everolimus (adverse effects), Graft Rejection (immunology), Graft Rejection (mortality), Graft Rejection (prevention & control), Graft Survival (drug effects), Humans (MeSH), Immunosuppressive Agents (administration & dosage), Immunosuppressive Agents (adverse effects), Kidney Transplantation (adverse effects), Kidney Transplantation (mortality), Middle Aged (MeSH), Mycophenolic Acid (administration & dosage), Risk Factors (MeSH), Tacrolimus (administration & dosage), Tacrolimus (adverse effects), Time Factors (MeSH), Treatment Outcome (MeSH).
MESH :
- chemical , administration & dosage : Calcineurin Inhibitors, Cyclosporine, Everolimus, Immunosuppressive Agents, Mycophenolic Acid, Tacrolimus.
- chemical , adverse effects : Calcineurin Inhibitors, Cyclosporine, Everolimus, Immunosuppressive Agents, Tacrolimus.
- adverse effects : Kidney Transplantation.
- drug effects : Graft Survival.
- immunology : Graft Rejection.
- mortality : Graft Rejection, Kidney Transplantation.
- prevention & control : Graft Rejection.
- Adult, Drug Therapy, Combination, Humans, Middle Aged, Risk Factors, Time Factors, Treatment Outcome.

Abstract

BACKGROUND

The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.

METHODS

TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.

RESULTS

Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.

CONCLUSIONS

De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.

DOI: 10.1097/TP.0000000000002626
PubMed: 30801548

Affiliations:

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Le document en format XML

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<author><name sortKey="Buchler, Matthias" sort="Buchler, Matthias" uniqKey="Buchler M" first="Matthias" last="Buchler">Matthias Buchler</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.</title>
<author><name sortKey="Tedesco Silva, Helio" sort="Tedesco Silva, Helio" uniqKey="Tedesco Silva H" first="Helio" last="Tedesco-Silva">Helio Tedesco-Silva</name>
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<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo</wicri:regionArea>
<placeName><settlement type="city">São Paulo</settlement>
<region type="state">État de São Paulo</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pascual, Julio" sort="Pascual, Julio" uniqKey="Pascual J" first="Julio" last="Pascual">Julio Pascual</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Nephrology, Hospital del Mar, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Department of Nephrology, Hospital del Mar, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Viklicky, Ondrej" sort="Viklicky, Ondrej" uniqKey="Viklicky O" first="Ondrej" last="Viklicky">Ondrej Viklicky</name>
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<country xml:lang="fr">République tchèque</country>
<wicri:regionArea>Department of Nephrology, Transplant Centre, Institute for Clinical and Experimental Medicine, Prague</wicri:regionArea>
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</affiliation>
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<author><name sortKey="Basic Jukic, Nikolina" sort="Basic Jukic, Nikolina" uniqKey="Basic Jukic N" first="Nikolina" last="Basic-Jukic">Nikolina Basic-Jukic</name>
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<country xml:lang="fr">Croatie</country>
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</affiliation>
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<author><name sortKey="Cassuto, Elisabeth" sort="Cassuto, Elisabeth" uniqKey="Cassuto E" first="Elisabeth" last="Cassuto">Elisabeth Cassuto</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Nephrology and Renal Transplantation, Hôpital Pasteur, Nice</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Nice</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kim, Dean Y" sort="Kim, Dean Y" uniqKey="Kim D" first="Dean Y" last="Kim">Dean Y. Kim</name>
<affiliation wicri:level="2"><nlm:affiliation>Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
<wicri:cityArea>Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Cruzado, Josep M" sort="Cruzado, Josep M" uniqKey="Cruzado J" first="Josep M" last="Cruzado">Josep M. Cruzado</name>
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<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Department of Nephrology, Hospital Universitari de Bellvitge, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
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<author><name sortKey="Sommerer, Claudia" sort="Sommerer, Claudia" uniqKey="Sommerer C" first="Claudia" last="Sommerer">Claudia Sommerer</name>
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<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
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<author><name sortKey="Adel Bakr, Mohamed" sort="Adel Bakr, Mohamed" uniqKey="Adel Bakr M" first="Mohamed" last="Adel Bakr">Mohamed Adel Bakr</name>
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<wicri:noRegion>Mansoura</wicri:noRegion>
</affiliation>
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<author><name sortKey="Garcia, Valter D" sort="Garcia, Valter D" uniqKey="Garcia V" first="Valter D" last="Garcia">Valter D. Garcia</name>
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<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Department of Renal Transplantation, Santa Casa de Misericórdia de Porto Alegre, Porto Alegre</wicri:regionArea>
<placeName><settlement type="city">Porto Alegre</settlement>
<region type="state">Rio Grande do Sul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Uyen, Huynh Do" sort="Uyen, Huynh Do" uniqKey="Uyen H" first="Huynh-Do" last="Uyen">Huynh-Do Uyen</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Nephrology and Hypertension, Inselspital Bern, Bern, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Nephrology and Hypertension, Inselspital Bern, Bern</wicri:regionArea>
<placeName><settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Russ, Graeme" sort="Russ, Graeme" uniqKey="Russ G" first="Graeme" last="Russ">Graeme Russ</name>
<affiliation wicri:level="1"><nlm:affiliation>Central and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital, Adelaide, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Central and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital, Adelaide</wicri:regionArea>
<wicri:noRegion>Adelaide</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Soo Kim, Myoung" sort="Soo Kim, Myoung" uniqKey="Soo Kim M" first="Myoung" last="Soo Kim">Myoung Soo Kim</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Transplantation Surgery, Severance Hospital Yonsei University Health System, Seoul, Republic of Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Transplantation Surgery, Severance Hospital Yonsei University Health System, Seoul</wicri:regionArea>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kuypers, Dirk" sort="Kuypers, Dirk" uniqKey="Kuypers D" first="Dirk" last="Kuypers">Dirk Kuypers</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Nephrology and Renal Transplantation, Gasthuisberg University Hospital, University of Leuven, Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Nephrology and Renal Transplantation, Gasthuisberg University Hospital, University of Leuven, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Department of Microbiology and Immunology, University of Leuven, Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Microbiology and Immunology, University of Leuven, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Buchler, Matthias" sort="Buchler, Matthias" uniqKey="Buchler M" first="Matthias" last="Buchler">Matthias Buchler</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Nephrology and Renal Transplantation, CHRU de Tours, Hôpital Bretonneau, Tours, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Nephrology and Renal Transplantation, CHRU de Tours, Hôpital Bretonneau, Tours</wicri:regionArea>
<placeName><region type="region">Centre-Val de Loire</region>
<region type="old region">Région Centre</region>
<settlement type="city">Tours</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Citterio, Franco" sort="Citterio, Franco" uniqKey="Citterio F" first="Franco" last="Citterio">Franco Citterio</name>
<affiliation wicri:level="3"><nlm:affiliation>Policlinico Foundation, A Gemelli University, IRCCS, Catholic University of the Sacred Heart, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Policlinico Foundation, A Gemelli University, IRCCS, Catholic University of the Sacred Heart, Rome</wicri:regionArea>
<placeName><settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hernandez Gutierrez, Maria Pilar" sort="Hernandez Gutierrez, Maria Pilar" uniqKey="Hernandez Gutierrez M" first="Maria Pilar" last="Hernandez Gutierrez">Maria Pilar Hernandez Gutierrez</name>
<affiliation wicri:level="1"><nlm:affiliation>Research and Development, Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Research and Development, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bernhardt, Peter" sort="Bernhardt, Peter" uniqKey="Bernhardt P" first="Peter" last="Bernhardt">Peter Bernhardt</name>
<affiliation wicri:level="1"><nlm:affiliation>Research and Development, Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Research and Development, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chadban, Steve" sort="Chadban, Steve" uniqKey="Chadban S" first="Steve" last="Chadban">Steve Chadban</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
</analytic>
<series><title level="j">Transplantation</title>
<idno type="eISSN">1534-6080</idno>
<imprint><date when="2019" type="published">2019</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term>
<term>Calcineurin Inhibitors (administration & dosage)</term>
<term>Calcineurin Inhibitors (adverse effects)</term>
<term>Cyclosporine (administration & dosage)</term>
<term>Cyclosporine (adverse effects)</term>
<term>Drug Therapy, Combination (MeSH)</term>
<term>Everolimus (administration & dosage)</term>
<term>Everolimus (adverse effects)</term>
<term>Graft Rejection (immunology)</term>
<term>Graft Rejection (mortality)</term>
<term>Graft Rejection (prevention & control)</term>
<term>Graft Survival (drug effects)</term>
<term>Humans (MeSH)</term>
<term>Immunosuppressive Agents (administration & dosage)</term>
<term>Immunosuppressive Agents (adverse effects)</term>
<term>Kidney Transplantation (adverse effects)</term>
<term>Kidney Transplantation (mortality)</term>
<term>Middle Aged (MeSH)</term>
<term>Mycophenolic Acid (administration & dosage)</term>
<term>Risk Factors (MeSH)</term>
<term>Tacrolimus (administration & dosage)</term>
<term>Tacrolimus (adverse effects)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Acide mycophénolique (administration et posologie)</term>
<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Association de médicaments (MeSH)</term>
<term>Ciclosporine (administration et posologie)</term>
<term>Ciclosporine (effets indésirables)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Immunosuppresseurs (administration et posologie)</term>
<term>Immunosuppresseurs (effets indésirables)</term>
<term>Inhibiteurs de la calcineurine (administration et posologie)</term>
<term>Inhibiteurs de la calcineurine (effets indésirables)</term>
<term>Rejet du greffon (immunologie)</term>
<term>Rejet du greffon (mortalité)</term>
<term>Rejet du greffon (prévention et contrôle)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Survie du greffon (effets des médicaments et des substances chimiques)</term>
<term>Tacrolimus (administration et posologie)</term>
<term>Tacrolimus (effets indésirables)</term>
<term>Transplantation rénale (effets indésirables)</term>
<term>Transplantation rénale (mortalité)</term>
<term>Évérolimus (administration et posologie)</term>
<term>Évérolimus (effets indésirables)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Calcineurin Inhibitors</term>
<term>Cyclosporine</term>
<term>Everolimus</term>
<term>Immunosuppressive Agents</term>
<term>Mycophenolic Acid</term>
<term>Tacrolimus</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Calcineurin Inhibitors</term>
<term>Cyclosporine</term>
<term>Everolimus</term>
<term>Immunosuppressive Agents</term>
<term>Tacrolimus</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Acide mycophénolique</term>
<term>Ciclosporine</term>
<term>Immunosuppresseurs</term>
<term>Inhibiteurs de la calcineurine</term>
<term>Tacrolimus</term>
<term>Évérolimus</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Kidney Transplantation</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Graft Survival</term>
</keywords>
<keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Survie du greffon</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Ciclosporine</term>
<term>Immunosuppresseurs</term>
<term>Inhibiteurs de la calcineurine</term>
<term>Tacrolimus</term>
<term>Transplantation rénale</term>
<term>Évérolimus</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Rejet du greffon</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Graft Rejection</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Graft Rejection</term>
<term>Kidney Transplantation</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Rejet du greffon</term>
<term>Transplantation rénale</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Graft Rejection</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Rejet du greffon</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Drug Therapy, Combination</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Risk Factors</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association de médicaments</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Résultat thérapeutique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30801548</PMID>
<DateCompleted><Year>2020</Year>
<Month>06</Month>
<Day>08</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>06</Month>
<Day>08</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1534-6080</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>103</Volume>
<Issue>9</Issue>
<PubDate><Year>2019</Year>
<Month>09</Month>
</PubDate>
</JournalIssue>
<Title>Transplantation</Title>
<ISOAbbreviation>Transplantation</ISOAbbreviation>
</Journal>
<ArticleTitle>Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.</ArticleTitle>
<Pagination><MedlinePgn>1953-1963</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1097/TP.0000000000002626</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.</AbstractText>
<AbstractText Label="METHODS">TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.</AbstractText>
<AbstractText Label="RESULTS">Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.</AbstractText>
<AbstractText Label="CONCLUSIONS">De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Tedesco-Silva</LastName>
<ForeName>Helio</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pascual</LastName>
<ForeName>Julio</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology, Hospital del Mar, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Viklicky</LastName>
<ForeName>Ondrej</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology, Transplant Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Basic-Jukic</LastName>
<ForeName>Nikolina</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cassuto</LastName>
<ForeName>Elisabeth</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology and Renal Transplantation, Hôpital Pasteur, Nice, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kim</LastName>
<ForeName>Dean Y</ForeName>
<Initials>DY</Initials>
<AffiliationInfo><Affiliation>Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cruzado</LastName>
<ForeName>Josep M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology, Hospital Universitari de Bellvitge, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sommerer</LastName>
<ForeName>Claudia</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Adel Bakr</LastName>
<ForeName>Mohamed</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Mansoura Urology and Nephrology Center, Mansoura, Egypt.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Garcia</LastName>
<ForeName>Valter D</ForeName>
<Initials>VD</Initials>
<AffiliationInfo><Affiliation>Department of Renal Transplantation, Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Uyen</LastName>
<ForeName>Huynh-Do</ForeName>
<Initials>HD</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology and Hypertension, Inselspital Bern, Bern, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Russ</LastName>
<ForeName>Graeme</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Central and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital, Adelaide, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Soo Kim</LastName>
<ForeName>Myoung</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Transplantation Surgery, Severance Hospital Yonsei University Health System, Seoul, Republic of Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kuypers</LastName>
<ForeName>Dirk</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology and Renal Transplantation, Gasthuisberg University Hospital, University of Leuven, Leuven, Belgium.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Microbiology and Immunology, University of Leuven, Leuven, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Buchler</LastName>
<ForeName>Matthias</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Nephrology and Renal Transplantation, CHRU de Tours, Hôpital Bretonneau, Tours, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Citterio</LastName>
<ForeName>Franco</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Policlinico Foundation, A Gemelli University, IRCCS, Catholic University of the Sacred Heart, Rome, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hernandez Gutierrez</LastName>
<ForeName>Maria Pilar</ForeName>
<Initials>MP</Initials>
<AffiliationInfo><Affiliation>Research and Development, Novartis Pharma AG, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bernhardt</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Research and Development, Novartis Pharma AG, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chadban</LastName>
<ForeName>Steve</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>TRANSFORM Investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Transplantation</MedlineTA>
<NlmUniqueID>0132144</NlmUniqueID>
<ISSNLinking>0041-1337</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D065095">Calcineurin Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>83HN0GTJ6D</RegistryNumber>
<NameOfSubstance UI="D016572">Cyclosporine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>9HW64Q8G6G</RegistryNumber>
<NameOfSubstance UI="D000068338">Everolimus</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>HU9DX48N0T</RegistryNumber>
<NameOfSubstance UI="D009173">Mycophenolic Acid</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>WM0HAQ4WNM</RegistryNumber>
<NameOfSubstance UI="D016559">Tacrolimus</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D065095" MajorTopicYN="N">Calcineurin Inhibitors</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016572" MajorTopicYN="N">Cyclosporine</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000068338" MajorTopicYN="N">Everolimus</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006084" MajorTopicYN="N">Graft Rejection</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006085" MajorTopicYN="N">Graft Survival</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007166" MajorTopicYN="N">Immunosuppressive Agents</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
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<li>Sydney</li>
<li>São Paulo</li>
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<country name="Italie"><region name="Latium"><name sortKey="Citterio, Franco" sort="Citterio, Franco" uniqKey="Citterio F" first="Franco" last="Citterio">Franco Citterio</name>
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</record>

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   |wiki=    Bois
   |area=    RapamycinFungusV1
   |flux=    Main
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   |type=    RBID
   |clé=     pubmed:30801548
   |texte=   Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.
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	Serveur d'exploration sur la rapamycine et les champignons
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur la rapamycine et les champignons

Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.

Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.

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