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Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial
BACKGROUND: Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove cl...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533735/ https://www.ncbi.nlm.nih.gov/pubmed/23206408 http://dx.doi.org/10.1186/1745-6215-13-231 |
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author | Boissonnat, Pascale Gaillard, Ségolène Mercier, Catherine Redonnet, Michel Lelong, Bernard Mattei, Marie-Françoise Mouly-Bandini, Annick Pattier, Sabine Sirinelli, Agnès Epailly, Eric Varnous, Shaida Billes, Marc-Alain Sebbag, Laurent Ecochard, René Cornu, Catherine Gueyffier, François |
author_facet | Boissonnat, Pascale Gaillard, Ségolène Mercier, Catherine Redonnet, Michel Lelong, Bernard Mattei, Marie-Françoise Mouly-Bandini, Annick Pattier, Sabine Sirinelli, Agnès Epailly, Eric Varnous, Shaida Billes, Marc-Alain Sebbag, Laurent Ecochard, René Cornu, Catherine Gueyffier, François |
author_sort | Boissonnat, Pascale |
collection | PubMed |
description | BACKGROUND: Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. METHODS: In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 < trough CsA concentrations <200 μg/L, n = 47) or a standard dose of Cyclosporine A (200 < trough CsA concentrations <300 μg/L, n = 48) for the three first post-transplant months along with mycophenolate mofetil and corticosteroids. Participants had a stable haemodynamic status, a serum creatinine level <250 μmol/L and the donors’ cold ischemia time was under six hours; multiorgan transplants were excluded. The change in serum creatinine level over 12 months was used as the main criterion for renal function. Intention-to-treat analysis was performed on the 95 randomised patients and a mixed generalised linear model of covariance was applied. RESULTS: At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. CONCLUSIONS: In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. TRIAL REGISTRATION: ClinicalTrials.gov NCT00159159 |
format | Online Article Text |
id | pubmed-3533735 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-35337352013-01-03 Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial Boissonnat, Pascale Gaillard, Ségolène Mercier, Catherine Redonnet, Michel Lelong, Bernard Mattei, Marie-Françoise Mouly-Bandini, Annick Pattier, Sabine Sirinelli, Agnès Epailly, Eric Varnous, Shaida Billes, Marc-Alain Sebbag, Laurent Ecochard, René Cornu, Catherine Gueyffier, François Trials Research BACKGROUND: Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. METHODS: In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 < trough CsA concentrations <200 μg/L, n = 47) or a standard dose of Cyclosporine A (200 < trough CsA concentrations <300 μg/L, n = 48) for the three first post-transplant months along with mycophenolate mofetil and corticosteroids. Participants had a stable haemodynamic status, a serum creatinine level <250 μmol/L and the donors’ cold ischemia time was under six hours; multiorgan transplants were excluded. The change in serum creatinine level over 12 months was used as the main criterion for renal function. Intention-to-treat analysis was performed on the 95 randomised patients and a mixed generalised linear model of covariance was applied. RESULTS: At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. CONCLUSIONS: In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. TRIAL REGISTRATION: ClinicalTrials.gov NCT00159159 BioMed Central 2012-12-03 /pmc/articles/PMC3533735/ /pubmed/23206408 http://dx.doi.org/10.1186/1745-6215-13-231 Text en Copyright ©2012 Boissonnat et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Boissonnat, Pascale Gaillard, Ségolène Mercier, Catherine Redonnet, Michel Lelong, Bernard Mattei, Marie-Françoise Mouly-Bandini, Annick Pattier, Sabine Sirinelli, Agnès Epailly, Eric Varnous, Shaida Billes, Marc-Alain Sebbag, Laurent Ecochard, René Cornu, Catherine Gueyffier, François Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title | Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title_full | Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title_fullStr | Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title_full_unstemmed | Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title_short | Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial |
title_sort | impact of the early reduction of cyclosporine on renal function in heart transplant patients: a french randomised controlled trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533735/ https://www.ncbi.nlm.nih.gov/pubmed/23206408 http://dx.doi.org/10.1186/1745-6215-13-231 |
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