Outcomes of de novo extended-release tacrolimus use (Advagraf®) in kidney transplantation: 1-year, single-center experience

Abstract

Aim: Once daily extended-release tacrolimus (tac-ER) was introduced to support medication adherence in kidney transplant (KTx) recipients, with similar efficacy to immediate-release tacrolimus (tac-IR). However, most of the experiences regarding tac-ER efficacy were obtained from the switches from tac-IR to tac-ER in kidney transplant recipients (KTRs). In this study, we aimed to demonstrate 1-year outcomes of de novo use of tac-ER in KTRs. Material and Method: This single-center retrospective study included 72 de novo KTRs between January 2020 and January 2021. KTRS were divided into two groups who received a tac-ER or tac-IR. 1-year allograft functions, allograft survival, daily doses of tacrolimus in milligram/day and milligram/kg/day, trough levels, and acute rejection episodes were compared between the two groups. The factors that might have an impact on allograft functions and acute rejection episodes also were investigated. Results: A total of 69 de novo kidney allograft recipients (30 recipients in the tac-ER and 39 recipients in the tac-ER groups); were evaluated. Three KTRs were excluded due to the deaths within the early posttransplant period. Serum creatinine and tacrolimus trough levels were similar for 12 months after transplantation (p>0.05). More daily tacrolimus doses (in milligram/day and milligram/kg/day) were required to obtain a targeted trough level up to 3 months in the tac-ER group. Acute rejection rates also were found similar between the two groups (p=0.281). Univariate regression analysis demonstrated that higher total daily tacrolimus doses within a posttransplant month 1 may (milligram/kg/day) have an impact on lower acute rejection episode(s) independent of tacrolimus trough levels (p=0.02). Conclusion: De novo use of extended-release tacrolimus Advagraf® is as effective as immediate-release tacrolimus in preventing acute rejection episode(s) and provides satisfactory 1-year allograft function and survival.

Keywords

• Extended-release tacrolimus
• acute rejection
• kidney transplantation

Böbrek naklinde de novo uzamış salınımlı takrolimus kullanımı sonuçları: tek merkez, 1 yıllık sonuçlar

Abstract

Amaç: Böbrek nakli alıcılarında günde tek doz uzamış salınımlı takrolimus (tac-ER) kullanımı, erken salınımlı takrolimus (tac-IR) kullanımına benzer etkinlik ve daha iyi ilaç uyumu sağlaması amacıyla geliştirilmiştir. Ancak uzamış salınımlı takrolimus ile ilgili deneyimler daha çok nakil sonrası dönemde yapılan “switch” protokollerine dayanmaktadır. Bu çalışmada böbrek alıcılarında de novo tac-ER kullanımı ile ilgili deneyimlerimizi ve 1 yıllık sonuçları sunmayı amaçladık. Gereç ve Yöntem: Bu tek merkezli retrospektif çalışmaya Ocak 2022-Ocak 2021 arasında yapılan 72 de novo böbrek nakli hastası dahil edilmiştir. Hastalar tac-ER ve tac-IR alan iki gruba ayrıldı. Bir yıllık allogreft fonksiyonları ve sağ kalımları, hastaların günlük ilaç dozları ve bunların akut rejeksiyon atakları ile ilişkileri karşılaştırıldı. Allogreft fonksiyonları ve akut rejeksiyon atakları üzerine etki eden faktörler incelendi. Bulgular: Toplam 69 hastanın (uzamış salınımlı grupta 30 hasta ve erken salınımlı grupta 39 hasta) verileri incelendi. Üç hasta posttransplant erken dönemde öldüğü için analize dahil edilmedi. Nakil sonrası 12 aylık izlem boyunca her iki grup arasında serum kreatinin ve takrolimus çukur değerler bencer bulundu (p>0,05). İlk 3 ay içinde hedef takrolimus değerlere ulaşmak için, tac-ER grubunda daha yüksek günlük dozlar (milligra/gün ve milligram/gün/kg) gerekti (p<0,05). Nakil sonrası ilk 12 ay içinde her iki grupta da rejeksiyon oranları benzerdi (p=0,281). Tek değişkenli analizde posttransplant 1. aydaki takrolimus dozu (milligram/kg/gün) takrolimus çukur değerinin aksine rejeksiyon gelişimi üzerinde etkili görüldü (p=0,02). Sonuç: Böbrek naklinde uzamış salınımlı takrolimusun (Advagraf®) de novo kullanımı, erken salınımlı takrolimus kullanımına benzer etkinlik, allogreft sağ kalımı ve fonksiyonu sağlar.

Keywords

• Uzamış salınımlı takrolimus
• akut rejeksiyon
• böbrek nakli

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