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Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study

BACKGROUND AND AIMS: To report 5‐year outcomes of the CERTITUDE study. METHODS: An observational study in patients with liver transplantation (LTx) compared the long‐term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACEs...

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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‐Philippe, Hardwigsen, Jean, Benkhatar, Yasmina, Derquenne, François, Conti, Filomena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826472/
https://www.ncbi.nlm.nih.gov/pubmed/35962772
http://dx.doi.org/10.1111/liv.15396
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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‐Philippe
Hardwigsen, Jean
Benkhatar, Yasmina
Derquenne, François
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‐Philippe
Hardwigsen, Jean
Benkhatar, Yasmina
Derquenne, François
Conti, Filomena
author_sort Saliba, Faouzi
collection PubMed
description BACKGROUND AND AIMS: To report 5‐year outcomes of the CERTITUDE study. METHODS: An observational study in patients with liver transplantation (LTx) compared the long‐term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACEs) and other safety parameters. All patients completing the 6‐month SIMCER study were recruited and analysed according to treatment received at randomization and actual treatment received during the follow‐up. RESULTS: Of the 143 enrolled patients, 119 completed the 5‐year follow‐up (everolimus [EVR], n = 55; tacrolimus [TAC], n = 64). The mean absolute change in estimated glomerular filtration rate was not statistically different between both groups (TAC, −15.53 ml/min/1.73 m(2) and EVR, –14.56 ml/min/1.73 m(2)). In the treatment subgroups based on actual treatment received, renal function was preserved better in the EVR subgroup compared with other subgroups (p = .051). Treated biopsy‐proven acute rejection was higher in the EVR group (15.4% vs. 6.4%); however, the majority of events were mild in severity. MACE occurred in 9.2% vs. 14.1% of patients in the EVR and TAC groups respectively (p = .370). De novo cancer was reported in 14 and 5 patients in EVR and TAC groups respectively. Hepatocellular carcinoma (HCC) recurrence was observed in the TAC group alone (n = 4). Adverse events and treatment discontinuation owing to an adverse event were higher in the EVR group. CONCLUSIONS: The CERTITUDE study demonstrated that EVR‐ and TAC‐based regimens have comparable efficacy, safety and tolerability up to 5 years post‐LTx.
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spelling pubmed-98264722023-01-09 Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study 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‐Philippe Hardwigsen, Jean Benkhatar, Yasmina Derquenne, François Conti, Filomena Liver Int Cirrhosis, Liver Failure and Transplantation BACKGROUND AND AIMS: To report 5‐year outcomes of the CERTITUDE study. METHODS: An observational study in patients with liver transplantation (LTx) compared the long‐term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACEs) and other safety parameters. All patients completing the 6‐month SIMCER study were recruited and analysed according to treatment received at randomization and actual treatment received during the follow‐up. RESULTS: Of the 143 enrolled patients, 119 completed the 5‐year follow‐up (everolimus [EVR], n = 55; tacrolimus [TAC], n = 64). The mean absolute change in estimated glomerular filtration rate was not statistically different between both groups (TAC, −15.53 ml/min/1.73 m(2) and EVR, –14.56 ml/min/1.73 m(2)). In the treatment subgroups based on actual treatment received, renal function was preserved better in the EVR subgroup compared with other subgroups (p = .051). Treated biopsy‐proven acute rejection was higher in the EVR group (15.4% vs. 6.4%); however, the majority of events were mild in severity. MACE occurred in 9.2% vs. 14.1% of patients in the EVR and TAC groups respectively (p = .370). De novo cancer was reported in 14 and 5 patients in EVR and TAC groups respectively. Hepatocellular carcinoma (HCC) recurrence was observed in the TAC group alone (n = 4). Adverse events and treatment discontinuation owing to an adverse event were higher in the EVR group. CONCLUSIONS: The CERTITUDE study demonstrated that EVR‐ and TAC‐based regimens have comparable efficacy, safety and tolerability up to 5 years post‐LTx. John Wiley and Sons Inc. 2022-09-01 2022-11 /pmc/articles/PMC9826472/ /pubmed/35962772 http://dx.doi.org/10.1111/liv.15396 Text en © 2022 The Authors. Liver International published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://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 Cirrhosis, Liver Failure and Transplantation
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‐Philippe
Hardwigsen, Jean
Benkhatar, Yasmina
Derquenne, François
Conti, Filomena
Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title_full Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title_fullStr Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title_full_unstemmed Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title_short Five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study
title_sort five‐year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: results from the certitude study
topic Cirrhosis, Liver Failure and Transplantation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826472/
https://www.ncbi.nlm.nih.gov/pubmed/35962772
http://dx.doi.org/10.1111/liv.15396
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