CoChat
Sign Up
Cited by 133Diabetes Treatment and ManagementRenal Transplantation Outcomes and TreatmentsDiabetes Management and Research

The DOI matches its Crossref record; 29 of the 30 references it cites were found in a registry or an index.

Empagliflozin in posttransplantation diabetes mellitus: A prospective, interventional pilot study on glucose metabolism, fluid volume, and patient safety

Open access
Schwaiger, Elisabeth, Burghart, Lukas, Signorini, Lorenzo, Ristl, Robin, Kopecky, Chantal, Tura, Andrea, Pacini, Giovanni, Wrba, Thomas, Antlanger, Marlies, Schmaldienst, Sabine, Werzowa, Johannes, Säemann, Marcus D., Hecking, Manfred·2019·American Journal of Transplantation
DOI 10.1111/ajt.15223PMC PMC6590167
Open this paper in CoChat — free account

Abstract

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).

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1111/ajt.15223

Cites

29 of 29 references verified0 citation errors · 0 not checkable

Statistics

Figures

Figure 1 Study design. Glycemic profiles included blood glucose measurements 4 times daily by the patients themselves (blood glucose profiles). Renal function parameters were controlled at every visit. KTRs, kidney transplant recipients; PTDM, posttransplantation diabetes mellitus; OGTT, oral glucose tolerance test
Figure 1 Study design. Glycemic profiles included blood glucose measurements 4 times daily by the patients themselves (blood glucose profiles). Renal function parameters were controlled at every visit. KTRs, kidney transplant recipients; PTDM, posttransplantation diabetes mellitus; OGTT, oral glucose tolerance testCC BY-NC · PubMed Central
Figure 2 Screening, enrollment, allocation, and completion of the study. KTRs, kidney transplant recipients; BG, blood glucose; eGFR, estimated glomerular filtration rate, PTDM, posttransplantation diabetes mellitus. The primary investigators of the study were able to personally screen approximately 900 of all 1120 patients for the diagnosis of posttransplantation diabetes mellitus during the inclusion period
Figure 2 Screening, enrollment, allocation, and completion of the study. KTRs, kidney transplant recipients; BG, blood glucose; eGFR, estimated glomerular filtration rate, PTDM, posttransplantation diabetes mellitus. The primary investigators of the study were able to personally screen approximately 900 of all 1120 patients for the diagnosis of posttransplantation diabetes mellitus during the inclusion periodCC BY-NC · PubMed Central
Figure 3 Oral glucose tolerance test (OGTT) results. Blood glucose, insulin, and c‐peptide levels determined by a 75 g oral glucose tolerance test after insulin and empagliflozin treatment. Fasting and 2‐hour glucose levels increased from 111 ± 21 mg/dL and 232 ± 82 mg/dL to 144 ± 45 mg/dL (P = .005) and 273 ± 116 mg/dL (P = .06), respectively, at 4 weeks (N = 14) and to 128 ± 27 (P = .02) and 251 ± 71 (P = .41), respectively, at 12 months (N = 8). Bold lines: baseline; dotted lines: after 4 weeks of empagliflozin treatment
Figure 3 Oral glucose tolerance test (OGTT) results. Blood glucose, insulin, and c‐peptide levels determined by a 75 g oral glucose tolerance test after insulin and empagliflozin treatment. Fasting and 2‐hour glucose levels increased from 111 ± 21 mg/dL and 232 ± 82 mg/dL to 144 ± 45 mg/dL (P = .005) and 273 ± 116 mg/dL (P = .06), respectively, at 4 weeks (N = 14) and to 128 ± 27 (P = .02) and 251 ± 71 (P = .41), respectively, at 12 months (N = 8). Bold lines: baseline; dotted lines: after 4 weeks of empagliflozin treatmentCC BY-NC · PubMed Central
Figure 4 Participants' self‐monitored blood glucose profiles over 28 days. During the first 3 days of empagliflozin treatment, the insulin dosage was slowly reduced (wash‐out phase). Means and standard deviations of blood glucose levels are displayed as bold lines (blood glucose levels during the initial 4‐week period on insulin alone) and dotted lines (blood glucose levels during empagliflozin treatment). Differences in estimated means were calculated using a mixed linear model, between insulin‐ vs empagliflozin‐treated patients: Fasting: mean 114.2 ± 26.3 mg/dL vs 132.5 ± 28.8 mg/dL (95% CI −0.5 to 37 mg/dL, P = .06). Pre‐lunch: mean 131.6 ± 28.8 mg/dL vs 155.9 ± 49.7 mg/dL (95% CI −0.2 to 49 mg/dL, P = .05). Pre‐supper: mean 138 ± 37.9 mg/dL vs 158.8 ± 48.5 mg/dL (95% CI −4 to 46 mg/dL, P = .1). Post‐supper: mean 144.6 ± 43.6 mg/dL vs 152.5 ± 45.2 mg/dL (95% CI −21 to 37 mg/dL; P = .6)
Figure 4 Participants' self‐monitored blood glucose profiles over 28 days. During the first 3 days of empagliflozin treatment, the insulin dosage was slowly reduced (wash‐out phase). Means and standard deviations of blood glucose levels are displayed as bold lines (blood glucose levels during the initial 4‐week period on insulin alone) and dotted lines (blood glucose levels during empagliflozin treatment). Differences in estimated means were calculated using a mixed linear model, between insulin‐ vs empagliflozin‐treated patients: Fasting: mean 114.2 ± 26.3 mg/dL vs 132.5 ± 28.8 mg/dL (95% CI −0.5 to 37 mg/dL, P = .06). Pre‐lunch: mean 131.6 ± 28.8 mg/dL vs 155.9 ± 49.7 mg/dL (95% CI −0.2 to 49 mg/dL, P = .05). Pre‐supper: mean 138 ± 37.9 mg/dL vs 158.8 ± 48.5 mg/dL (95% CI −4 to 46 mg/dL, P = .1). Post‐supper: mean 144.6 ± 43.6 mg/dL vs 152.5 ± 45.2 mg/dL (95% CI −21 to 37 mg/dL; P = .6)CC BY-NC · PubMed Central
Figure 5 Bacterial urinary tract infections. Kaplan–Meier curves for the study population (SP) vs the matched reference population (RP). “Proportion of event free” refers to urinary tract infections, dropping out, and end of study in the SP, but to urinary tract infections alone in the RP; P = .81 by log rank test. N, number of patients
Figure 5 Bacterial urinary tract infections. Kaplan–Meier curves for the study population (SP) vs the matched reference population (RP). “Proportion of event free” refers to urinary tract infections, dropping out, and end of study in the SP, but to urinary tract infections alone in the RP; P = .81 by log rank test. N, number of patientsCC BY-NC · PubMed Central
Figure 6 Concept. OGTT, oral glucose tolerance test; KTRs, kidney transplant recipients
Figure 6 Concept. OGTT, oral glucose tolerance test; KTRs, kidney transplant recipientsCC BY-NC · PubMed Central

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 30 references

Cited by

Sorted by citations

See all 133

Related

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)
DOI
10.1111/ajt.15223
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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review