Evaluation of adherence and tolerability of prolonged-release tacrolimus (Advagraf (TM)) in kidney transplant patients in Germany: A multicenter, noninterventional study

Lehner, Lukas J. and Reinke, Petra and Hoerstrup, Jan H. and Rath, Thomas and Suwelack, Barbara and Kraemer, Bernhard K. and Budde, Klemens and Banas, Bernhard (2018) Evaluation of adherence and tolerability of prolonged-release tacrolimus (Advagraf (TM)) in kidney transplant patients in Germany: A multicenter, noninterventional study. CLINICAL TRANSPLANTATION, 32 (1): e13142. ISSN 0902-0063, 1399-0012

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Abstract

This study assessed adherence to prolonged-release tacrolimus (PR-T)-based immunosuppression during routine maintenance of renal transplant recipients in Germany. Patients had received PR-T for 1month at inclusion. Data were collected during four visits (V): baseline (V1), 6 (V2), 12 (V3), and 18 (V4) months. Composite primary endpoint: nonadherence at V4, defined as self-reported nonadherence on the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS((c))), investigator-rated nonadherence, and/or V4 tacrolimus trough level outside a predefined range. Secondary endpoints: individual BAASIS items, incidence of rejection, kidney function, and safety. Overall, 153 adult kidney recipients (mean [standard deviation] time post-transplant 5.8 [4.6]years) were included. Nonadherence was high at V4 (67.7% [95% confidence interval 58.9%, 75.6%]). Medication-taking adherence was 86.9% and 91.3% at V1 and V4, respectively; adherence to timing of medication intake was 58.2% and 58.3%, with little evidence of missed doses/drug holidays. Investigators rated adherence good in 85.6% of patients (V4). Two (1.3%) patients had acute rejection episodes. Kidney function remained stable (mean creatinine clearance, V1: 62.1mL/min; V4: 65.3mL/min). Investigators rated effectiveness of PR-T as very good/good in 91.5% of patients. Most patients (94.7%) found PR-T dosing more convenient than immediate-release tacrolimus. PR-T was well tolerated with high medication persistence.

Item Type: Article
Uncontrolled Keywords: ONCE-DAILY TACROLIMUS; RENAL-TRANSPLANT; IMMUNOSUPPRESSIVE MEDICATIONS; NONADHERENCE; RECIPIENTS; NONCOMPLIANCE; FORMULATION; ANTIBODY; FAILURE; REGIMEN; immunosuppression; kidney transplantation; medication adherence; tacrolimus
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Abteilung für Nephrologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 23 Mar 2020 05:41
Last Modified: 23 Mar 2020 05:41
URI: https://pred.uni-regensburg.de/id/eprint/15466

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