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

被引：9

作者：

Fernandez Rivera, Constantino ^{[1
]}

Calvo Rodriguez, Maria ^{[1
]}

Luis Poveda, Jose ^{[2
]}

Pascual, Julio ^{[3
]}

Crespo, Marta ^{[3
]}

Gomez, Gonzalo ^{[4
]}

Cabello Pelegrin, Sheila ^{[4
]}

Paul, Javier ^{[5
]}

Lauzurica, Ricardo ^{[6
]}

Perez Mir, Monica ^{[6
]}

Moreso, Francesc ^{[7
]}

Perello, Manel ^{[7
]}

Andres, Amado ^{[8
]}

Gonzalez, Esther ^{[8
]}

Fernandez, Ana ^{[9
]}

Mendiluce, Alicia ^{[10
]}

Fernandez Carbajo, Beatriz ^{[10
]}

Sanchez Fructuoso, Ana ^{[11
]}

Calvo, Natividad ^{[11
]}

Suarez, Alejandro ^{[12
]}

Bernal Blanco, Gabriel ^{[12
]}

Osuna, Antonio ^{[13
]}

Carmen Ruiz-Fuentes, M. ^{[13
]}

Melilli, Edoardo ^{[14
]}

Montero Perez, Nuria ^{[14
]}

Ramos, Ana ^{[15
]}

Fernandez, Beatriz ^{[15
]}

Lopez, Veronica ^{[16
]}

Hernandez, Domingo ^{[16
]}

机构：

[1] Univ Hosp A Coruna, Nephrol Dept, Xubias 84, La Coruna 15006, Spain

[2] Univ Hosp La Fe, Pharm Dept, Valencia, Spain

[3] Univ Hosp Mar, Nephrol Dept, Barcelona, Spain

[4] Univ Hosp Son Espases, Nephrol Dept, Palma De Mallorca, Spain

[5] Hosp Miguel Servet, Nephrol Dept, Zaragoza, Spain

[6] Univ Hosp Germans Trias & Pujol, Nephrol Dept, Badalona, Spain

[7] Univ Autonoma Barcelona, Univ Hosp Vall dHebron, Dept Med, Nephrol Dept, Barcelona, Spain

[8] Univ Hosp Doce Octubre, Nephrol Dept, Madrid, Spain

[9] Univ Hosp Ramon Y Cajal, Nephrol Dept, Madrid, Spain

[10] Univ Hosp Clin Valladolid, Nephrol Dept, Valladolid, Spain

[11] Univ Hosp Clin San Carlos, Nephrol Dept, Madrid, Spain

[12] Univ Hosp Virgen Rocio, Nephrol Dept, Seville, Spain

[13] Univ Hosp Virgen Nieves, Nephrol Dept, Granada, Spain

[14] Univ Hosp Bellvitge, Nephrol Dept, Lhospitalet De Llobregat, Spain

[15] Fdn Jimenez Diaz, Nephrol Dept, Madrid, Spain

[16] Univ Malaga, Univ Hosp Reg, Nephrol Dept, REDinREN RED16 0009 0006,IBIMA, Malaga, Spain

来源：

CLINICAL TRANSPLANTATION | 2022年 / 36卷 / 03期

关键词：

bioavailability; clinical practice; pharmacokinetics; renal transplantation; tacrolimus; treatment failure; EXTENDED-RELEASE TACROLIMUS; TWICE-DAILY TACROLIMUS; PHASE-2; TRIAL; DOUBLE-BLIND; OPEN-LABEL; CONVERSION; LCPT; NEPHROTOXICITY; CYCLOSPORINE; CAPSULES;

D O I：

10.1111/ctr.14550

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

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.

引用

页数：12

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