Effect of Everolimus with low-dose tacrolimus on development of new-onset diabetes after transplantation and allograft function in kidney transplantation: a multicenter, open-label, randomized trial
Open accessAbstract
BACKGROUND This randomized controlled trial aimed to investigate the effect of everolimus (EVL) with low-dose tacrolimus (Tac) on the development of post-transplantation diabetes mellitus (PTDM) in kidney transplantation (KT). MATERIAL AND METHODS Seventy-seven kidney transplant patients from 4 transplant centers were included. Patients were randomized to the "EVL group" (n=38) and the "TAC group" (n=39). The target Tac trough level was 2 to 5 ng/mL in the EVL group and 5 to 10 ng/mL in the TAC group. RESULTS The 1-year cumulative incidence of PTDM in all patients was 7.8%, and no difference was found between the 2 groups (P=0.0819). Insulin resistance measured with the homeostatic model assessment for insulin resistance showed a significant increase only in the TAC group (1.11 to 1.30, P=0.0492). Allograft rejection rate and estimated glomerular filtration rate (eGFR) follow-ups every 3 months were not significantly different between the 2 groups. However, the EVL group showed a significant increase in the mean eGFR at 9 months and 12 months after KT compared to the baseline value (P=0.0242 and 0.0491, respectively). The EVL group showed lower insulin resistance and higher allograft function in comparison to the TAC group. CONCLUSIONS EVL-based immunosuppressive therapy with lower Tac exposure could be a safer alternative for maintenance treatment.
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Risk factors for PTDM include general diabetes risks (such as age, family history of diabetes, obesity) and transplant-specific factors, such as use of immunosuppressant agents.
“Risk factors for PTDM include both general diabetes risks (such as age, family history of diabetes, obesity, etc.) and transplant-speci fi c factors, such as use of immunosuppressant agents (144 -146).”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [145]
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- Authors
- Kim, H. D., Chang, J.-Y., Chung, B. H., Kim, C.-D., Lee, S.-H., Kim, Y. H., & Yang, C. W.
- Affiliations
- Catholic University of Korea (KR)
- Kyungpook National University (KR)
- Kyung Hee University (KR)
- Inje University (KR)
- Corresponding author
- Yang, Chul Woo
- Venue
- Annals of Transplantation
- Published
- 2021-01-22
- Volume
- 26
- Pages
- e927984-e927984
- ISSN
- 1425-9524 (ISSN-L)
- 2329-0358
- PMC
- PMC7836319
- OpenAlex
- W3124193833
- Cited by
- 17
- References
- 49
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 4 · 2022: 5 · 2021: 3
- FWCI
- 3.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Annals of Transplantation (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- everolimus, tacrolimus, kidney transplantation, post-transplant diabetes mellitus, insulin resistance, allograft function, immunosuppressive therapy, tacrolimus trough levels, estimated glomerular filtration rate, allograft rejection
- MeSH terms
- Everolimus, Adult, Diabetes Mellitus, Female, Glomerular Filtration Rate, Humans, Immunosuppressive Agents, Male, Middle Aged, Kidney Transplantation, Tacrolimus, Allografts
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