Cargando…

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus

BACKGROUND: The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf(®)) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus...

Descripción completa

Detalles Bibliográficos
Autores principales: Connor, Andrew, Prowse, Andrew, Newell, Paul, Rowe, Peter A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094386/
https://www.ncbi.nlm.nih.gov/pubmed/27818747
http://dx.doi.org/10.1093/ckj/sfs154
_version_ 1782465092861820928
author Connor, Andrew
Prowse, Andrew
Newell, Paul
Rowe, Peter A.
author_facet Connor, Andrew
Prowse, Andrew
Newell, Paul
Rowe, Peter A.
author_sort Connor, Andrew
collection PubMed
description BACKGROUND: The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf(®)) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf(®) to a generic formulation (Adoport(®)) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf(®) with those receiving Adoport(®). METHODS: Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. RESULTS: A total of 48 patients received Prograf(®) and 51 received Adoport(®). At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. CONCLUSIONS: This is the first study to compare the clinical outcomes of patients receiving Adoport(®) with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf(®) or Adoport(®) from the time of renal transplantation. These early outcome data therefore support the use of Adoport(®) in place of Prograf(®) as a potential cost-saving measure.
format Online
Article
Text
id pubmed-5094386
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-50943862016-11-04 A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus Connor, Andrew Prowse, Andrew Newell, Paul Rowe, Peter A. Clin Kidney J Original Contributions BACKGROUND: The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf(®)) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf(®) to a generic formulation (Adoport(®)) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf(®) with those receiving Adoport(®). METHODS: Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. RESULTS: A total of 48 patients received Prograf(®) and 51 received Adoport(®). At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. CONCLUSIONS: This is the first study to compare the clinical outcomes of patients receiving Adoport(®) with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf(®) or Adoport(®) from the time of renal transplantation. These early outcome data therefore support the use of Adoport(®) in place of Prograf(®) as a potential cost-saving measure. Oxford University Press 2013-02 2012-11-21 /pmc/articles/PMC5094386/ /pubmed/27818747 http://dx.doi.org/10.1093/ckj/sfs154 Text en © The Author 2012. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For permissions, please email: journals.permissions@oup.com. http://creativecommons.org/licenses/by-nc/4.0/ this is an open access article distributed under the terms of the creative commons attribution non-commercial license (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. for commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Contributions
Connor, Andrew
Prowse, Andrew
Newell, Paul
Rowe, Peter A.
A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title_full A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title_fullStr A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title_full_unstemmed A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title_short A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport(®) or Prograf(®) preparations of tacrolimus
title_sort single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered adoport(®) or prograf(®) preparations of tacrolimus
topic Original Contributions
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094386/
https://www.ncbi.nlm.nih.gov/pubmed/27818747
http://dx.doi.org/10.1093/ckj/sfs154
work_keys_str_mv AT connorandrew asinglecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT prowseandrew asinglecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT newellpaul asinglecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT rowepetera asinglecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT connorandrew singlecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT prowseandrew singlecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT newellpaul singlecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus
AT rowepetera singlecentrecomparisonoftheclinicaloutcomesat6monthsofrenaltransplantrecipientsadministeredadoportorprografpreparationsoftacrolimus