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An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project

The goal of post-transplant immunosuppressive drug therapy is to prevent organ rejection while minimizing drug toxicities. In clinical practice, a multidrug approach is commonly used and involves drugs with different mechanisms of action, including calcineurin inhibitors (CNI) (tacrolimus or cyclosp...

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Autores principales: Belleudi, Valeria, Rosa, Alessandro C., Finocchietti, Marco, Poggi, Francesca R., Marino, Maria Lucia, Massari, Marco, Spila Alegiani, Stefania, Masiero, Lucia, Ricci, Andrea, Bedeschi, Gaia, Puoti, Francesca, Cardillo, Massimo, Pierobon, Silvia, Nordio, Maurizio, Ferroni, Eliana, Zanforlini, Martina, Piccolo, Giuseppe, Leone, Olivia, Ledda, Stefano, Carta, Paolo, Garau, Donatella, Lucenteforte, Ersilia, Davoli, Marina, Addis, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9521186/
https://www.ncbi.nlm.nih.gov/pubmed/36188626
http://dx.doi.org/10.3389/fphar.2022.959267
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author Belleudi, Valeria
Rosa, Alessandro C.
Finocchietti, Marco
Poggi, Francesca R.
Marino, Maria Lucia
Massari, Marco
Spila Alegiani, Stefania
Masiero, Lucia
Ricci, Andrea
Bedeschi, Gaia
Puoti, Francesca
Cardillo, Massimo
Pierobon, Silvia
Nordio, Maurizio
Ferroni, Eliana
Zanforlini, Martina
Piccolo, Giuseppe
Leone, Olivia
Ledda, Stefano
Carta, Paolo
Garau, Donatella
Lucenteforte, Ersilia
Davoli, Marina
Addis, Antonio
author_facet Belleudi, Valeria
Rosa, Alessandro C.
Finocchietti, Marco
Poggi, Francesca R.
Marino, Maria Lucia
Massari, Marco
Spila Alegiani, Stefania
Masiero, Lucia
Ricci, Andrea
Bedeschi, Gaia
Puoti, Francesca
Cardillo, Massimo
Pierobon, Silvia
Nordio, Maurizio
Ferroni, Eliana
Zanforlini, Martina
Piccolo, Giuseppe
Leone, Olivia
Ledda, Stefano
Carta, Paolo
Garau, Donatella
Lucenteforte, Ersilia
Davoli, Marina
Addis, Antonio
author_sort Belleudi, Valeria
collection PubMed
description The goal of post-transplant immunosuppressive drug therapy is to prevent organ rejection while minimizing drug toxicities. In clinical practice, a multidrug approach is commonly used and involves drugs with different mechanisms of action, including calcineurin inhibitors (CNI) (tacrolimus or cyclosporine), antimetabolite (antimet) (mycophenolate or azathioprine), inhibitors of mechanistic target of rapamycin (mTOR) (sirolimus or everolimus), and/or steroids. Although evidence based on several randomized clinical trials is available, the optimal immunosuppressive therapy has not been established and may vary among organ transplant settings. To improve the knowledge on this topic, a multiregional research network to Compare the Effectiveness and Safety of Immunosuppressive drugs in Transplant patients (CESIT) has been created with the financial support of the Italian Medicines Agency. In this article, we describe the development of this network, the framework that was designed to perform observational studies, and we also give an overview of the preliminary results that we have obtained. A multi-database transplant cohort was enrolled using a common data model based on healthcare claims data of four Italian regions (Lombardy, Veneto, Lazio, and Sardinia). Analytical datasets were created using an open-source tool for distributed analysis. To link the National Transplant Information System to the regional transplant cohorts, a semi-deterministic record linkage procedure was performed. Overall, 6,914 transplant patients from 2009–19 were identified: 4,029 (58.3%) for kidney, 2,219 (32.1%) for liver, 434 (6.3%) for heart, and 215 (3.1%) for lung. As expected, demographic and clinical characteristics showed considerable variability among organ settings. Although the triple therapy in terms of CNI + antimet/mTOR + steroids was widely dispensed for all settings (63.7% for kidney, 33.5% for liver, 53.3% for heart, and 63.7% for lung), differences in the active agents involved were detected. The CESIT network represents a great opportunity to study several aspects related to the use, safety, and effectiveness of post-transplant maintenance immunosuppressive therapy in real practice.
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spelling pubmed-95211862022-09-30 An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project Belleudi, Valeria Rosa, Alessandro C. Finocchietti, Marco Poggi, Francesca R. Marino, Maria Lucia Massari, Marco Spila Alegiani, Stefania Masiero, Lucia Ricci, Andrea Bedeschi, Gaia Puoti, Francesca Cardillo, Massimo Pierobon, Silvia Nordio, Maurizio Ferroni, Eliana Zanforlini, Martina Piccolo, Giuseppe Leone, Olivia Ledda, Stefano Carta, Paolo Garau, Donatella Lucenteforte, Ersilia Davoli, Marina Addis, Antonio Front Pharmacol Pharmacology The goal of post-transplant immunosuppressive drug therapy is to prevent organ rejection while minimizing drug toxicities. In clinical practice, a multidrug approach is commonly used and involves drugs with different mechanisms of action, including calcineurin inhibitors (CNI) (tacrolimus or cyclosporine), antimetabolite (antimet) (mycophenolate or azathioprine), inhibitors of mechanistic target of rapamycin (mTOR) (sirolimus or everolimus), and/or steroids. Although evidence based on several randomized clinical trials is available, the optimal immunosuppressive therapy has not been established and may vary among organ transplant settings. To improve the knowledge on this topic, a multiregional research network to Compare the Effectiveness and Safety of Immunosuppressive drugs in Transplant patients (CESIT) has been created with the financial support of the Italian Medicines Agency. In this article, we describe the development of this network, the framework that was designed to perform observational studies, and we also give an overview of the preliminary results that we have obtained. A multi-database transplant cohort was enrolled using a common data model based on healthcare claims data of four Italian regions (Lombardy, Veneto, Lazio, and Sardinia). Analytical datasets were created using an open-source tool for distributed analysis. To link the National Transplant Information System to the regional transplant cohorts, a semi-deterministic record linkage procedure was performed. Overall, 6,914 transplant patients from 2009–19 were identified: 4,029 (58.3%) for kidney, 2,219 (32.1%) for liver, 434 (6.3%) for heart, and 215 (3.1%) for lung. As expected, demographic and clinical characteristics showed considerable variability among organ settings. Although the triple therapy in terms of CNI + antimet/mTOR + steroids was widely dispensed for all settings (63.7% for kidney, 33.5% for liver, 53.3% for heart, and 63.7% for lung), differences in the active agents involved were detected. The CESIT network represents a great opportunity to study several aspects related to the use, safety, and effectiveness of post-transplant maintenance immunosuppressive therapy in real practice. Frontiers Media S.A. 2022-09-15 /pmc/articles/PMC9521186/ /pubmed/36188626 http://dx.doi.org/10.3389/fphar.2022.959267 Text en Copyright © 2022 Belleudi, Rosa, Finocchietti, Poggi, Marino, Massari, Spila Alegiani, Masiero, Ricci, Bedeschi, Puoti, Cardillo, Pierobon, Nordio, Ferroni, Zanforlini, Piccolo, Leone, Ledda, Carta, Garau, Lucenteforte, Davoli Addis, and CESIT Study Group. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Belleudi, Valeria
Rosa, Alessandro C.
Finocchietti, Marco
Poggi, Francesca R.
Marino, Maria Lucia
Massari, Marco
Spila Alegiani, Stefania
Masiero, Lucia
Ricci, Andrea
Bedeschi, Gaia
Puoti, Francesca
Cardillo, Massimo
Pierobon, Silvia
Nordio, Maurizio
Ferroni, Eliana
Zanforlini, Martina
Piccolo, Giuseppe
Leone, Olivia
Ledda, Stefano
Carta, Paolo
Garau, Donatella
Lucenteforte, Ersilia
Davoli, Marina
Addis, Antonio
An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title_full An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title_fullStr An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title_full_unstemmed An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title_short An Italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: Framework and perspectives of the CESIT project
title_sort italian multicentre distributed data research network to study the use, effectiveness, and safety of immunosuppressive drugs in transplant patients: framework and perspectives of the cesit project
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9521186/
https://www.ncbi.nlm.nih.gov/pubmed/36188626
http://dx.doi.org/10.3389/fphar.2022.959267
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