P1774CONVERSION FROM TWICE-DAILY TACROLIMUS (TAC-IR) TO ONCE-DAILY EXTENDED RELEASE TACROLIMUS (LCPT) IN EVEROLIMUS TREATED STABLE KIDNEY TRANSPLANT RECIPIENTS
NEPHROLOGY DIALYSIS TRANSPLANTATION(2020)
摘要
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<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<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.
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