Tacrolimus Formulation, Exposure Variability, and Outcomes in Kidney Transplant Recipients.
Elaine F Lai, Huong Thao Nguyen, Olusegun Famure and 2 others
PMID 36562176WHAT IT FOUND
Switching stable kidney transplant recipients from twice-daily to once-daily tacrolimus did not reduce trough-level variability.
High variability was associated with worse graft outcomes.
Key findings
01In the final analysed group of 463 kidney transplant recipients, converting from twice-daily to once-daily tacrolimus did not reduce trough-level variability by SD, CV, or IPV%.
02Among converted patients, post-conversion SD above 0.92 and CV above 0.16 were associated with higher total graft failure, while IPV% above 7.7 was not.
03As continuous measures, each 1-unit increase in SD or IPV% and each 0.1-unit increase in CV were associated with increased hazards for total graft failure and death with graft function.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
Only 463 of 2,119 transplanted patients were analysed, because patients needed to be in the conversion program, have enough trough levels, and meet stability criteria. The cohort was clinically stable and had a median 4.5 years from transplant to conversion, so results may not apply to early post-transplant patients or those needing intensive management. The outcome analysis had only 36 total graft failure events and was underpowered, especially for death-censored graft failure. It was a single-center observational study, so residual confounding cannot be ruled out and causation cannot be inferred. The first 3 months after conversion were excluded, so early variability or trough-level drops were not captured. Conversion was a program-wide policy, not randomised, and some patients were not converted for physician discretion or preference. Data came from a 2012 conversion program, which may limit applicability to current practice or other formulations.
Declared interests
The authors declared no potential conflicts of interest and received no financial support for the research, authorship, or publication.
The easy way to misread this
Do not conclude that once-daily tacrolimus reduces variability or improves graft outcomes. The conversion comparison did not show a reduction, and the graft-outcome associations were observational, selected for stable patients, and underpowered.