Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study

Multicenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6...

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Autores: Fernandez Rivera, Constantino, Calvo Rodriguez, Maria, Poveda, Jose Luis, Pascual, Julio, Crespo, Marta, Gomez, Gonzalo, Cabello Pelegrin, Sheila, Paul, Javier, Lauzurica, Ricardo, Perez Mir, Monica, Moreso, Francesc, Perello, Manel, Andres Cano, Ignacio, Gonzalez, Esther, Fernandez, Ana, Mendiluce, Alicia, Fernandez Carbajo, Beatriz, Sanchez Fructuoso, Ana, Calvo, Natividad, Suarez, Alejandro, Bernal Blanco, Gabriel, Osuna, Antonio, Ruiz-Fuentes, M. Carmen, Melilli, Edoardo, Montero Perez, Nuria, Ramos, Ana, Fernandez, Beatriz, Lopez, Veronica, Hernandez, Domingo, Better Study
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/19467
Acceso en línea:https://hdl.handle.net/20.500.13003/19467
Access Level:acceso abierto
Palabra clave:Immunosuppressive Agents
Kidney Transplantation
Prospective Studies
Graft Rejection
Tacrolimus
Biological Availability
Drug Administration Schedule
Humans
Transplant Recipients
Receptores de Trasplantes
Esquema de Medicación
Disponibilidad Biológica
Humanos
Estudios Prospectivos
Inmunosupresores
Rechazo de Injerto
Trasplante de Riñón
bioavailability
clinical practice
pharmacokinetics
renal transplantation
tacrolimus
treatment failure
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network_name_str España
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spelling Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better studyFernandez Rivera, ConstantinoCalvo Rodriguez, MariaPoveda, Jose LuisPascual, JulioCrespo, MartaGomez, GonzaloCabello Pelegrin, SheilaPaul, JavierLauzurica, RicardoPerez Mir, MonicaMoreso, FrancescPerello, ManelAndres Cano, IgnacioGonzalez, EstherFernandez, AnaMendiluce, AliciaFernandez Carbajo, BeatrizSanchez Fructuoso, AnaCalvo, NatividadSuarez, AlejandroBernal Blanco, GabrielOsuna, AntonioRuiz-Fuentes, M. CarmenMelilli, EdoardoMontero Perez, NuriaRamos, AnaFernandez, BeatrizLopez, VeronicaHernandez, DomingoBetter StudyImmunosuppressive AgentsKidney TransplantationProspective StudiesGraft RejectionTacrolimusBiological AvailabilityDrug Administration ScheduleHumansTransplant RecipientsReceptores de TrasplantesEsquema de MedicaciónDisponibilidad BiológicaHumanosEstudios ProspectivosTacrolimusInmunosupresoresRechazo de InjertoTrasplante de Riñónbioavailabilityclinical practicepharmacokineticsrenal transplantationtacrolimustreatment failureMulticenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6 months. Data from 218 participants were evaluated: 129 in the LCPT group (Envarsus) and 89 in the PR-Tac (Advagraf) group. Patients in the LCPT group exhibited higher relative bioavailability (C-min /total daily dose [TDD]) vs. PR-Tac (61% increase; P < .001) with similar C-min and 30% lower TDD levels (P < .0001). The incidence of treatment failure was 3.9% in the LCPT group and 9.0% in the PR-Tac group (P = .117). Study discontinuation rates were 6.2% in the LCPT group and 12.4% in the PR-Tac group (P = .113). Adverse events, renal function and other complications were comparable between groups. The median accumulated dose of tacrolimus in the LCPT group from day 14 to month 6 was 889 mg. Compared to PR-Tac, LCPT showed higher relative bioavailability, similar effectiveness at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.Wiley20222022-03-0120222022-03-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/19467reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/194672026-06-22T12:44:07Z
dc.title.none.fl_str_mv Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
title Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
spellingShingle Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
Fernandez Rivera, Constantino
Immunosuppressive Agents
Kidney Transplantation
Prospective Studies
Graft Rejection
Tacrolimus
Biological Availability
Drug Administration Schedule
Humans
Transplant Recipients
Receptores de Trasplantes
Esquema de Medicación
Disponibilidad Biológica
Humanos
Estudios Prospectivos
Tacrolimus
Inmunosupresores
Rechazo de Injerto
Trasplante de Riñón
bioavailability
clinical practice
pharmacokinetics
renal transplantation
tacrolimus
treatment failure
title_short Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
title_full Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
title_fullStr Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
title_full_unstemmed Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
title_sort Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
dc.creator.none.fl_str_mv Fernandez Rivera, Constantino
Calvo Rodriguez, Maria
Poveda, Jose Luis
Pascual, Julio
Crespo, Marta
Gomez, Gonzalo
Cabello Pelegrin, Sheila
Paul, Javier
Lauzurica, Ricardo
Perez Mir, Monica
Moreso, Francesc
Perello, Manel
Andres Cano, Ignacio
Gonzalez, Esther
Fernandez, Ana
Mendiluce, Alicia
Fernandez Carbajo, Beatriz
Sanchez Fructuoso, Ana
Calvo, Natividad
Suarez, Alejandro
Bernal Blanco, Gabriel
Osuna, Antonio
Ruiz-Fuentes, M. Carmen
Melilli, Edoardo
Montero Perez, Nuria
Ramos, Ana
Fernandez, Beatriz
Lopez, Veronica
Hernandez, Domingo
Better Study
author Fernandez Rivera, Constantino
author_facet Fernandez Rivera, Constantino
Calvo Rodriguez, Maria
Poveda, Jose Luis
Pascual, Julio
Crespo, Marta
Gomez, Gonzalo
Cabello Pelegrin, Sheila
Paul, Javier
Lauzurica, Ricardo
Perez Mir, Monica
Moreso, Francesc
Perello, Manel
Andres Cano, Ignacio
Gonzalez, Esther
Fernandez, Ana
Mendiluce, Alicia
Fernandez Carbajo, Beatriz
Sanchez Fructuoso, Ana
Calvo, Natividad
Suarez, Alejandro
Bernal Blanco, Gabriel
Osuna, Antonio
Ruiz-Fuentes, M. Carmen
Melilli, Edoardo
Montero Perez, Nuria
Ramos, Ana
Fernandez, Beatriz
Lopez, Veronica
Hernandez, Domingo
Better Study
author_role author
author2 Calvo Rodriguez, Maria
Poveda, Jose Luis
Pascual, Julio
Crespo, Marta
Gomez, Gonzalo
Cabello Pelegrin, Sheila
Paul, Javier
Lauzurica, Ricardo
Perez Mir, Monica
Moreso, Francesc
Perello, Manel
Andres Cano, Ignacio
Gonzalez, Esther
Fernandez, Ana
Mendiluce, Alicia
Fernandez Carbajo, Beatriz
Sanchez Fructuoso, Ana
Calvo, Natividad
Suarez, Alejandro
Bernal Blanco, Gabriel
Osuna, Antonio
Ruiz-Fuentes, M. Carmen
Melilli, Edoardo
Montero Perez, Nuria
Ramos, Ana
Fernandez, Beatriz
Lopez, Veronica
Hernandez, Domingo
Better Study
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Immunosuppressive Agents
Kidney Transplantation
Prospective Studies
Graft Rejection
Tacrolimus
Biological Availability
Drug Administration Schedule
Humans
Transplant Recipients
Receptores de Trasplantes
Esquema de Medicación
Disponibilidad Biológica
Humanos
Estudios Prospectivos
Tacrolimus
Inmunosupresores
Rechazo de Injerto
Trasplante de Riñón
bioavailability
clinical practice
pharmacokinetics
renal transplantation
tacrolimus
treatment failure
topic Immunosuppressive Agents
Kidney Transplantation
Prospective Studies
Graft Rejection
Tacrolimus
Biological Availability
Drug Administration Schedule
Humans
Transplant Recipients
Receptores de Trasplantes
Esquema de Medicación
Disponibilidad Biológica
Humanos
Estudios Prospectivos
Tacrolimus
Inmunosupresores
Rechazo de Injerto
Trasplante de Riñón
bioavailability
clinical practice
pharmacokinetics
renal transplantation
tacrolimus
treatment failure
description Multicenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6 months. Data from 218 participants were evaluated: 129 in the LCPT group (Envarsus) and 89 in the PR-Tac (Advagraf) group. Patients in the LCPT group exhibited higher relative bioavailability (C-min /total daily dose [TDD]) vs. PR-Tac (61% increase; P < .001) with similar C-min and 30% lower TDD levels (P < .0001). The incidence of treatment failure was 3.9% in the LCPT group and 9.0% in the PR-Tac group (P = .117). Study discontinuation rates were 6.2% in the LCPT group and 12.4% in the PR-Tac group (P = .113). Adverse events, renal function and other complications were comparable between groups. The median accumulated dose of tacrolimus in the LCPT group from day 14 to month 6 was 889 mg. Compared to PR-Tac, LCPT showed higher relative bioavailability, similar effectiveness at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-03-01
2022
2022-03-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.13003/19467
url https://hdl.handle.net/20.500.13003/19467
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv reponame:Docusalut
instname:Conselleria de Salut i Consum del Govern de les Illes Balears
instname_str Conselleria de Salut i Consum del Govern de les Illes Balears
reponame_str Docusalut
collection Docusalut
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,81155

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