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Empagliflozin in posttransplantation diabetes mellitus: A prospective, interventional pilot study on glucose metabolism, fluid volume, and patient safety
Open accessAbstract
The safety and efficacy of sodium-glucose cotransporter 2 inhibitors in posttransplantation diabetes mellitus is unknown. We converted stable kidney transplant patients to 10 mg empagliflozin, aiming at replacing their insulin therapy (<40 IU/d). N = 14 participants (the required sample size) completed the study visits through 4 weeks and N = 8 through 12 months. Oral glucose tolerance test (OGTT)-derived 2-hour glucose (primary end point) increased from 232 ± 82 mg/dL (baseline) to 273 ± 116 mg/dL (4 weeks, P = .06) and to 251 ± 71 mg/dL (12 months, P = .41). Self-monitored blood glucose and hemoglobin A1c were also clinically inferior with empagliflozin monotherapy, such that insulin was reinstituted in 3 of 8 remaining participants. Five participants (2 of them dropouts) vs nine of 24 matched reference patients developed bacterial urinary tract infections (P = .81). In empagliflozin-treated participants, oral glucose insulin sensitivity decreased and beta-cell glucose sensitivity increased at the 4-week and 12-month OGTTs. Estimated glomerular filtration rate and bioimpedance spectroscopy-derived extracellular and total body fluid volumes decreased by 4 weeks, but recovered. All participants lost body weight. No participant developed ketoacidosis; 1 patient developed balanitis. In conclusion, although limited by sample size and therefore preliminary, these results suggest that empagliflozin can safely be used as add-on therapy, if posttransplant diabetes patients are monitored closely (NCT03113110).
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“For T2D and posttransplant diabetes, it is reasonable to treat kidney transplant recipients with metformin according to eGFR, as for the broader population with T2D, because risks of metformin are related to kidney function (80–84).”
From Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) (2022) · cites this paper as [84]
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Miyazaki, R., Miyagi, K., & Yoshida, M. (2020) · Renal Replacement Therapy · doi:10.1186/s41100-020-00303-x · Cited by 5
Bilancio, G., Hamzeh, S., Vecchione, N., Russo, D., Iacuzzo, C., Apicella, L., Pietro, R. A. D., Vitale, P., Amicone, M., Pisani, A., et al. (2025) · Biomedicines · doi:10.3390/biomedicines13061303 · Cited by 4
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Sanyal, D., Biswas, M., & Chaudhari, N. (2020) · Diabetes & Metabolic Syndrome Clinical Research & Reviews · doi:10.1016/j.dsx.2020.11.019 · Cited by 4
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Metadata
- Authors
- Schwaiger, E., Burghart, L., Signorini, L., Ristl, R., Kopecky, C., Tura, A., Pacini, G., Wrba, T., Antlanger, M., Schmaldienst, S., Werzowa, J., Säemann, M. D., & Hecking, M.
- Affiliations
- Medical University of Vienna (AT)
- National Research Council (IT)
- Hanusch Hospital (AT)
- Wilhelminen Hospital (AT)
- Corresponding author
- Hecking, Manfred
- ORCID
- Venue
- American Journal of Transplantation
- Publisher
- Elsevier BV
- Published
- 2019-03
- Volume
- 19
- Issue
- 3
- Pages
- 907-919
- ISSN
- 1600-6135 (ISSN-L)
- PMC
- PMC6590167
- OpenAlex
- W2905936571
- Cited by
- 133
- References
- 30
- Citations by year
- 2026: 10 · 2025: 20 · 2024: 18 · 2023: 22 · 2022: 19 · 2021: 26 · 2020: 14 · 2019: 3
- FWCI
- 8.76
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- American Journal of Transplantation (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- empagliflozin, SGLT2 inhibitors, post-transplant diabetes mellitus, kidney transplantation, insulin therapy, glucose metabolism, urinary tract infection, body fluid volume, extracellular volume, beta-cell function, oral glucose tolerance, HbA1c, weight loss, drug safety
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Benzhydryl Compounds, Blood Glucose, Body Composition, Body Fluids, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Glucosides, Graft Rejection, Graft Survival, Humans, Insulin, Male, Middle Aged, Pilot Projects, Postoperative Complications, Prognosis, Prospective Studies, Retrospective Studies, Risk Factors, Islets of Langerhans Transplantation, Patient Safety, Early Medical Intervention
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