scholarly journals Safety and Effectiveness of Conversion From Cyclosporine to Once-Daily Prolonged-Release Tacrolimus in Stable Kidney Transplant Patients: A Multicenter Observational Study in Japan

2018 ◽  
Vol 50 (10) ◽  
pp. 3266-3274 ◽  
Author(s):  
S. Usuki ◽  
S. Uno ◽  
H. Sugamori ◽  
H. Tanaka ◽  
A. Aikawa
2021 ◽  
Vol 2 (1) ◽  
pp. 49-56
Author(s):  
Valeria Cademartori ◽  
Fabio Massarino ◽  
Emanuele L. Parodi ◽  
Ernesto Paoletti ◽  
Rodolfo Russo ◽  
...  

The use of tacrolimus (Tac) may be involved in the development of new-onset diabetes after transplantation (NODAT) in a dose-related manner. This study aimed to evaluate the effects of a standard twice-daily formulation of Tac (TacBID) vs. the once-daily slow-release formulation (TacOD) on the basal insulin resistance indexes (Homa and McAuley), and related metabolic parameters, in a cohort of kidney transplant patients. We retrospectively evaluated 20 stable renal transplant recipients who were switched from TacBID to TacOD. Blood levels of Tac were analyzed at one-month intervals from 6 months before to 8 months after conversion. Moreover, Homa and McAuley indexes, C-peptide, insulin, HbA1c, uric acid, triglycerides, low-density lipoprotein (LDL) and high-density lipoprotein (HDL)-cholesterol serum levels and their associations with Tac levels were evaluated. We observed a significant decrease in Tac exposure (8.5 ± 2 ng/mL, CV 0.23 vs. 6.1 ± 1.9 ng/mL, CV 0.31, TacBID vs. TacOD periods, p < 0.001) and no significant changes in Homa (1.42 ± 0.4 vs. 1.8 ± 0.7, p > 0.05) and McAuley indexes (7.12 ± 1 vs. 7.58 ± 1.4, p > 0.05). Similarly, blood levels of glucose, insulin, HbA1c, lipids, and uric acid were unchanged between the two periods, while C-peptide resulted significantly lower after conversion to TacOD. These data suggest that in kidney transplant recipients, reduced Tac exposure has no significant effects on basal insulin sensitivity indexes and metabolic parameters.


2010 ◽  
Vol 42 (10) ◽  
pp. 4047-4048 ◽  
Author(s):  
F. Tinti ◽  
A. Meçule ◽  
L. Poli ◽  
A. Bachetoni ◽  
I. Umbro ◽  
...  

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Orsolya Cseprekal ◽  
Adrienn Marton ◽  
Szilárd Török ◽  
Attila Patonai ◽  
Katalin Földes ◽  
...  

Abstract Background and Aims Stable kidney transplant patients (KTX) treated according to TRANSFORM study protocol (TAC-IR + everolimus (EVR) + corticosteroid) were converted from twice daily TAC-IR to novel (MELT-dose) once-daily tacrolimus formulation (LCPT) on a 1:0.7 total daily dose (TDD) basis. Tolerability, safety, and trough level (Co) – TDD characteristics of the conversion (CV) was analyzed in a single center retrospective observational study. Method Between Sep. 2017 and Aug. 2018 38 KTX recipients were included. Pre- and post-CV TAC TDD, Co and TAC Co/D as well as EVR TDD and Co data were evaluated 4, 2 weeks before and 4 consecutive times after CV (94 (74-112 median IQR) post-transplant days). Pre- and post-CV eGFR, routine lab parameters and occurrence of adverse events were also investigated. Results In one patient 2 weeks after CV EVR was stopped due to infection, 37 KTX (males 22 (58%), age 54 (42-63) years) finished the entire observational period. According to CV protocol the median TDD of LCPT was lower than pre-CV TAC-IR at each visit: 4.5(3.5-7) mg/day pre-CV versus 3.5 (2.5-5), 3.6 (2.5-5), 3.5 (2.5-5) and 3.5 (2-5) (p&lt;0.001) post-CV. Mean TAC Co decreased from pre-CV Co 7.8 (6.4-9.5) ng/ml to 6.7 (4.8, 8.6), 7.0 (5.2, 9.6), 6.5 (5.7, 8.4) and 7.2 (5.4, 8.7) (p&lt;0.001). LCPT Co /TDD did not change: 1.6 (1.1-2.5) pre- and 2.1 (1.1- 2.9), 2.1 (1.1- 4.1), 1.6 (1.3- 3.5), 2.0 (1.4-4.1) (p = 0.18) post-CV. EVR Co /TDD (1.6 (1.3-2.1), 1.6 (1.3; 2.3), 1.6 (1.3-2.0), 1.6 (1.2-2.2)) remained similar to pre-CV: 1.6 (1.4- 2.4) (p = 0.65). There was no change in eGFR, hemoglobin levels and no drug related adverse event was observed during the study period. Conclusion Conversion from TAC-IR to LCPT in everolimus treated stable KTX recipients resulted in a significant post-CV decrease in TAC- Co, whilst Co/TDD remained unchanged. The conversion was safe and had no effect on EVR Co and TDD. Further investigations are needed to define optimal TAC-IR to LCPT conversion dose rate.


2020 ◽  
Vol 52 (5) ◽  
pp. 1547-1551
Author(s):  
Francesca Tinti ◽  
Gabriele Schiaffini ◽  
Ilaria Umbro ◽  
Assunta Zavatto ◽  
Luca Poli ◽  
...  

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