Title :

Tacrolimus Exposure Before and After a Switch From Twice-Daily Immediate-Release to Once-Daily Prolonged Release Tacrolimus: The ENVARSWITCH Study.

Author(s) :

Monchaud, Caroline [Auteur]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Woillard, Jean-Baptiste [Auteur]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Crépin, Sabrina [Auteur]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Tafzi, Naïma [Auteur]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Micallef, Ludovic [Auteur]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Rerolle, Jean-Philippe [Auteur]
Service de Néphrologie, Dialyse, Transplantations [CHU Limoges]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Dharancy, Sebastien [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Conti, Filomena [Auteur]
CHU Pitié-Salpêtrière [AP-HP]
Choukroun, Gabriel [Auteur]
CHU Amiens-Picardie
Thierry, Antoine [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Buchler, Matthias [Auteur]
Centre Hospitalier Régional Universitaire de Tours [CHRU Tours]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Salamé, Ephrem [Auteur]
Centre Hospitalier Régional Universitaire de Tours [CHRU Tours]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Garrouste, Cyril [Auteur]
CHU Clermont-Ferrand
Duvoux, Christophe [Auteur]
Hôpital Henri Mondor
Colosio, Charlotte [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Merville, Pierre [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Anglicheau, Dany [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Etienney, Isabelle [Auteur]
CHU Rouen
Saliba, Faouzi [Auteur]
Hôpital Paul Brousse
Mariat, Christophe [Auteur]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] [CHU ST-E]
Debette-Gratien, Marilyne [Auteur]
CHU Limoges
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Marquet, Pierre [Auteur]
CHU Limoges
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]

Journal title :

Transplant International

Abbreviated title :

Transpl Int

Volume number :

36

Pages :

11366

Publication date :

2023-08-18

ISSN :

1432-2277

English keyword(s) :

kidney transplantation
liver transplantation
LCP-tacrolimus
AUC monitoring
dried blood spots
conversion
therapeutic drug monitoring
dose individualization

English abstract : [en]

LCP-tacrolimus displays enhanced oral bioavailability compared to immediate-release (IR-) tacrolimus. The ENVARSWITCH study aimed to compare tacrolimus AUC in stable kidney (KTR) and liver transplant recipients (LTR) on ...
Show more >LCP-tacrolimus displays enhanced oral bioavailability compared to immediate-release (IR-) tacrolimus. The ENVARSWITCH study aimed to compare tacrolimus AUC in stable kidney (KTR) and liver transplant recipients (LTR) on IR-tacrolimus converted to LCP-tacrolimus, in order to re-evaluate the 1:0.7 dose ratio recommended in the context of a switch and the efficiency of the subsequent dose adjustment. Tacrolimus AUC was obtained by Bayesian estimation based on three concentrations measured in dried blood spots before (V2), after the switch (V3), and after LCP-tacrolimus dose adjustment intended to reach the pre-switch AUC (V4). AUC estimates and distributions were compared using the bioequivalence rule for narrow therapeutic range drugs (Westlake 90% CI within 0.90-1.11). Fifty-three KTR and 48 LTR completed the study with no major deviation. AUC bioequivalence was met in the entire population and in KTR between V2 and V4 and between V2 and V3. In LTR, the Westlake 90% CI was close to the acceptance limits between V2 and V4 (90% CI = [0.96-1.14]) and between V2 and V3 (90% CI = [0.96-1.15]). The 1:0.7 dose ratio is convenient for KTR but may be adjusted individually for LTR. The combination of DBS and Bayesian estimation for tacrolimus dose adjustment may help with reaching appropriate exposure to tacrolimus rapidly after a switch.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-02-03T22:23:43Z
2024-03-13T15:28:58Z