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Evaluation of adherence and tolerability of prolonged‐release tacrolimus (Advagraf™) in kidney transplant patients in Germany: A multicenter, noninterventional study
Author(s) -
Lehner Lukas J.,
Reinke Petra,
Hörstrup Jan H.,
Rath Thomas,
Suwelack Barbara,
Krämer Bernhard K.,
Budde Klemens,
Banas Bernhard
Publication year - 2018
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.13142
Subject(s) - medicine , tacrolimus , dosing , tolerability , immunosuppression , renal function , confidence interval , kidney transplantation , clinical endpoint , interquartile range , kidney transplant , kidney disease , creatinine , transplantation , adverse effect , urology , clinical trial
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 ≥1 month 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 © ), 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: 62.1 mL/min; V4: 65.3 mL/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.