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Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years

The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroid...

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Autores principales: Saliba, Faouzi, Duvoux, Christophe, Dharancy, Sébastien, Dumortier, Jérôme, Calmus, Yvon, Gugenheim, Jean, Kamar, Nassim, Salamé, Ephrem, Neau‐Cransac, Martine, Vanlemmens, Claire, Durand, François, Pageaux, Georges, Leroy, Vincent, Hardwigsen, Jean, Gharbi, Hakam, Masson, Cécile, Tindel, Malka, Conti, Filomena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383505/
https://www.ncbi.nlm.nih.gov/pubmed/31631501
http://dx.doi.org/10.1002/lt.25664
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author Saliba, Faouzi
Duvoux, Christophe
Dharancy, Sébastien
Dumortier, Jérôme
Calmus, Yvon
Gugenheim, Jean
Kamar, Nassim
Salamé, Ephrem
Neau‐Cransac, Martine
Vanlemmens, Claire
Durand, François
Pageaux, Georges
Leroy, Vincent
Hardwigsen, Jean
Gharbi, Hakam
Masson, Cécile
Tindel, Malka
Conti, Filomena
author_facet Saliba, Faouzi
Duvoux, Christophe
Dharancy, Sébastien
Dumortier, Jérôme
Calmus, Yvon
Gugenheim, Jean
Kamar, Nassim
Salamé, Ephrem
Neau‐Cransac, Martine
Vanlemmens, Claire
Durand, François
Pageaux, Georges
Leroy, Vincent
Hardwigsen, Jean
Gharbi, Hakam
Masson, Cécile
Tindel, Malka
Conti, Filomena
author_sort Saliba, Faouzi
collection PubMed
description The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR‐treated patients and 78 TAC‐treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR‐treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3‐12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m(2), respectively (P = 0.90) and adjusted mean change in eGFR from randomization was −8.0 versus −13.5 mL/minute/1.73 m(2) (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR‐treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC‐treated patients (P = 0.05). Treated biopsy‐proven acute rejection affected 4 EVR‐treated patients and 2 TAC patients during months 6‐24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR‐treated and TAC‐treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI‐free EVR‐based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance.
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spelling pubmed-73835052020-07-27 Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years Saliba, Faouzi Duvoux, Christophe Dharancy, Sébastien Dumortier, Jérôme Calmus, Yvon Gugenheim, Jean Kamar, Nassim Salamé, Ephrem Neau‐Cransac, Martine Vanlemmens, Claire Durand, François Pageaux, Georges Leroy, Vincent Hardwigsen, Jean Gharbi, Hakam Masson, Cécile Tindel, Malka Conti, Filomena Liver Transpl Original Articles The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR‐treated patients and 78 TAC‐treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR‐treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3‐12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m(2), respectively (P = 0.90) and adjusted mean change in eGFR from randomization was −8.0 versus −13.5 mL/minute/1.73 m(2) (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR‐treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC‐treated patients (P = 0.05). Treated biopsy‐proven acute rejection affected 4 EVR‐treated patients and 2 TAC patients during months 6‐24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR‐treated and TAC‐treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI‐free EVR‐based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance. John Wiley and Sons Inc. 2019-11-19 2019-12 /pmc/articles/PMC7383505/ /pubmed/31631501 http://dx.doi.org/10.1002/lt.25664 Text en Copyright © 2019 The Authors. Liver Transplantation published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Saliba, Faouzi
Duvoux, Christophe
Dharancy, Sébastien
Dumortier, Jérôme
Calmus, Yvon
Gugenheim, Jean
Kamar, Nassim
Salamé, Ephrem
Neau‐Cransac, Martine
Vanlemmens, Claire
Durand, François
Pageaux, Georges
Leroy, Vincent
Hardwigsen, Jean
Gharbi, Hakam
Masson, Cécile
Tindel, Malka
Conti, Filomena
Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title_full Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title_fullStr Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title_full_unstemmed Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title_short Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years
title_sort early switch from tacrolimus to everolimus after liver transplantation: outcomes at 2 years
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383505/
https://www.ncbi.nlm.nih.gov/pubmed/31631501
http://dx.doi.org/10.1002/lt.25664
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