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Abstract

Background and Aims

Glucagon-like peptide 1 receptor agonists (GLP1-RA) have demonstrated cardiovascular and renal benefits in obese diabetic patients. However, the evidence for oral semaglutide in kidney transplant (KT) patients is very limited. Our study aims to analyze the effectiveness and safety of oral semaglutide in diabetic KT patients.

Method

Retrospective cohort study of KT with diabetes who started oral semaglutide in 3 Spanish hospitals (Puerta del Mar University Hospital, Jerez de la Frontera University Hospital and Puerto Real University Hospital) between December 2021 and December 2023. None of them had previously received subcutaneous GLP1-RA. Clinical and demographic variables were analyzed. Glomerular filtration rate (eGFR), proteinuria, and weight were collected at the start of the treatment and after 6 and 12 months. We analyze glycemic control, blood pressure, lipid profile and trough level, dose and C/D ratio of tacrolimus. Acute rejections (AR), de novo donor-specific antibodies (dnDSA) and adverse effects were documented. Parametric and non-parametric tests were performed according to the normality of the sample.

Results

In this period, 22 KT with DM started treatment with oral Semaglutide, of which 16 patients completed follow-up for 6 months and 11 patients for 1 year. Fourteen (63.6%) had developed post-transplant DM. The mean age was 61 years, and 77% were men. The mean baseline estimated glomerular filtration rate (eGFR) was 46.1 ml/min/1.73 m2, the baseline body mass index was 34.7 kg/m2 and the median KT vintage was 45 months. Three patients were on treatment with SGLT2i at the start of the drug. Variables compared during the follow-up are shown in Table 1. Four patients (18%) suffered gastrointestinal side effects. No dnDSA were documented during follow-up. One episode of AR was documented after drug initiation.

Conclusions

We show the longest series of oral semaglutide in KT patients. Our results support that it can be a good option for managing DM in KT, especially in obese patients.

Table 1:
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Baseline, 6-month and 12-month values of clinical and analytical variables compared during the follow-up.

Baseline (n = 16)6 months (n = 16)p valueBaseline (n = 11)12 months (n = 11)p value
eGFR (ml/min/1.73 m2), mean (SD)42.1 (20.8)44.9 (25.1)0.240143.4 (23.7)54.2 (28.5)0.0241
UACR (mg/g), median [IQR]104.8 [25.0, 472.0]85.1 [12.4, 282.6]0.173267.4 [20.0, 138.9]16.6 [54.1, 128.0]0.4772
Weight (kg), mean (SD)91.4 (12.7)87.1 (15.1)0.0011100.2 (20.7)95.9 (6.9)0.0241
BMI (kg/m2), mean (SD)35.5 (6.5)34.2 (7.1)0.018135.9 (6.8)34.2 (7.2)0.0381
HbA1c (mmol/L), median [IQR]
HbA1c (%), median [IQR]		8.4 [8.1, 10.5]
6.9 [6.7, 8.2]		8.2 [6.7, 10.6]
6.3 [5.8, 8.3]
0.0492		8.4 [8.1, 10.6]
6.9 [6.7, 8.3]		8.4 [6.9, 10.2]
6.9 [6.0, 8.0]
0.0902
Insulin Dose (IU/day), mean (SD)33.8 (19.9)30.7 (13.7)0.262138.4 (24.4)35.4 (19.2)0.1951
Total cholesterol (mg/dl), mean (SD)147.6 (36.1)133.5 (29.2)0.0111155.5 (32.3)140.6 (25.5)0.2511
LDL cholesterol (mg/dl), median [IQR]74.0 [49.3, 113.5]57 [45.0, 94.0]0.112285.0 [67.0, 114.0]60.0 [49.0, 75.0]0.0752
Triglycerides (mg/dl), mean (SD)144.5 (75.0)137.9 (50.4)0.7061141.1 (76.2)149.8 (51.6)0.1471
SBP (mmHg), mean (SD)138.9 (16.4)135.2 (17.6)0.2231147.0 (15.8)142.4 (11.5)0.3491
DBP (mmHg), mean (SD)77.8 (10.5)76.9 (10.2)0.133178.0 (13.4)79.9 (8.5)0.6141
Prednisone Dose (mg/day), median [IQR]5.0 [5.0, 5.0]5.0 [5.0, 5.0]0.18025.0 [5.0, 5.0]5.0 [5.0, 5.0]0.1802
Tacrolimus Dose (mg/day), median [IQR]3.0 [2.1, 4.2]3.0 [2.1, 4.8]0.13023.25 [3.0, 5.25]3.5 [3.0, 5.25]0.1172
Tacrolimus Trough Levels (ng/ml) mean (SD)6.3 (1.5)5.8 (1.9)0.42516.7 (1.4)7.3 (1.7)0.4751
Tacrolimus C/D Ratio, mean (SD)2.05 (0.9)1.8 (1.1)0.30711.7 (0.8)1.8 (1.0)0.1741
Baseline (n = 16)6 months (n = 16)p valueBaseline (n = 11)12 months (n = 11)p value
eGFR (ml/min/1.73 m2), mean (SD)42.1 (20.8)44.9 (25.1)0.240143.4 (23.7)54.2 (28.5)0.0241
UACR (mg/g), median [IQR]104.8 [25.0, 472.0]85.1 [12.4, 282.6]0.173267.4 [20.0, 138.9]16.6 [54.1, 128.0]0.4772
Weight (kg), mean (SD)91.4 (12.7)87.1 (15.1)0.0011100.2 (20.7)95.9 (6.9)0.0241
BMI (kg/m2), mean (SD)35.5 (6.5)34.2 (7.1)0.018135.9 (6.8)34.2 (7.2)0.0381
HbA1c (mmol/L), median [IQR]
HbA1c (%), median [IQR]		8.4 [8.1, 10.5]
6.9 [6.7, 8.2]		8.2 [6.7, 10.6]
6.3 [5.8, 8.3]
0.0492		8.4 [8.1, 10.6]
6.9 [6.7, 8.3]		8.4 [6.9, 10.2]
6.9 [6.0, 8.0]
0.0902
Insulin Dose (IU/day), mean (SD)33.8 (19.9)30.7 (13.7)0.262138.4 (24.4)35.4 (19.2)0.1951
Total cholesterol (mg/dl), mean (SD)147.6 (36.1)133.5 (29.2)0.0111155.5 (32.3)140.6 (25.5)0.2511
LDL cholesterol (mg/dl), median [IQR]74.0 [49.3, 113.5]57 [45.0, 94.0]0.112285.0 [67.0, 114.0]60.0 [49.0, 75.0]0.0752
Triglycerides (mg/dl), mean (SD)144.5 (75.0)137.9 (50.4)0.7061141.1 (76.2)149.8 (51.6)0.1471
SBP (mmHg), mean (SD)138.9 (16.4)135.2 (17.6)0.2231147.0 (15.8)142.4 (11.5)0.3491
DBP (mmHg), mean (SD)77.8 (10.5)76.9 (10.2)0.133178.0 (13.4)79.9 (8.5)0.6141
Prednisone Dose (mg/day), median [IQR]5.0 [5.0, 5.0]5.0 [5.0, 5.0]0.18025.0 [5.0, 5.0]5.0 [5.0, 5.0]0.1802
Tacrolimus Dose (mg/day), median [IQR]3.0 [2.1, 4.2]3.0 [2.1, 4.8]0.13023.25 [3.0, 5.25]3.5 [3.0, 5.25]0.1172
Tacrolimus Trough Levels (ng/ml) mean (SD)6.3 (1.5)5.8 (1.9)0.42516.7 (1.4)7.3 (1.7)0.4751
Tacrolimus C/D Ratio, mean (SD)2.05 (0.9)1.8 (1.1)0.30711.7 (0.8)1.8 (1.0)0.1741

eGFR: Estimated Glomerular Filtration Rate, SD: Standard Deviation, IQR: Interquartile Range, UACR: Urine Albumin-to-Creatinine Ratio, BMI: Body Mass Index, SBP: Systolic Blood Pressure, DBP: Diastolic Blood Pressure, C/D: Concentration-Dose.

1

Paired sample t-test.

2

Paired Wilcoxon Signed Rank Test.

Table 1:
Open in new tab

Baseline, 6-month and 12-month values of clinical and analytical variables compared during the follow-up.

Baseline (n = 16)6 months (n = 16)p valueBaseline (n = 11)12 months (n = 11)p value
eGFR (ml/min/1.73 m2), mean (SD)42.1 (20.8)44.9 (25.1)0.240143.4 (23.7)54.2 (28.5)0.0241
UACR (mg/g), median [IQR]104.8 [25.0, 472.0]85.1 [12.4, 282.6]0.173267.4 [20.0, 138.9]16.6 [54.1, 128.0]0.4772
Weight (kg), mean (SD)91.4 (12.7)87.1 (15.1)0.0011100.2 (20.7)95.9 (6.9)0.0241
BMI (kg/m2), mean (SD)35.5 (6.5)34.2 (7.1)0.018135.9 (6.8)34.2 (7.2)0.0381
HbA1c (mmol/L), median [IQR]
HbA1c (%), median [IQR]		8.4 [8.1, 10.5]
6.9 [6.7, 8.2]		8.2 [6.7, 10.6]
6.3 [5.8, 8.3]
0.0492		8.4 [8.1, 10.6]
6.9 [6.7, 8.3]		8.4 [6.9, 10.2]
6.9 [6.0, 8.0]
0.0902
Insulin Dose (IU/day), mean (SD)33.8 (19.9)30.7 (13.7)0.262138.4 (24.4)35.4 (19.2)0.1951
Total cholesterol (mg/dl), mean (SD)147.6 (36.1)133.5 (29.2)0.0111155.5 (32.3)140.6 (25.5)0.2511
LDL cholesterol (mg/dl), median [IQR]74.0 [49.3, 113.5]57 [45.0, 94.0]0.112285.0 [67.0, 114.0]60.0 [49.0, 75.0]0.0752
Triglycerides (mg/dl), mean (SD)144.5 (75.0)137.9 (50.4)0.7061141.1 (76.2)149.8 (51.6)0.1471
SBP (mmHg), mean (SD)138.9 (16.4)135.2 (17.6)0.2231147.0 (15.8)142.4 (11.5)0.3491
DBP (mmHg), mean (SD)77.8 (10.5)76.9 (10.2)0.133178.0 (13.4)79.9 (8.5)0.6141
Prednisone Dose (mg/day), median [IQR]5.0 [5.0, 5.0]5.0 [5.0, 5.0]0.18025.0 [5.0, 5.0]5.0 [5.0, 5.0]0.1802
Tacrolimus Dose (mg/day), median [IQR]3.0 [2.1, 4.2]3.0 [2.1, 4.8]0.13023.25 [3.0, 5.25]3.5 [3.0, 5.25]0.1172
Tacrolimus Trough Levels (ng/ml) mean (SD)6.3 (1.5)5.8 (1.9)0.42516.7 (1.4)7.3 (1.7)0.4751
Tacrolimus C/D Ratio, mean (SD)2.05 (0.9)1.8 (1.1)0.30711.7 (0.8)1.8 (1.0)0.1741
Baseline (n = 16)6 months (n = 16)p valueBaseline (n = 11)12 months (n = 11)p value
eGFR (ml/min/1.73 m2), mean (SD)42.1 (20.8)44.9 (25.1)0.240143.4 (23.7)54.2 (28.5)0.0241
UACR (mg/g), median [IQR]104.8 [25.0, 472.0]85.1 [12.4, 282.6]0.173267.4 [20.0, 138.9]16.6 [54.1, 128.0]0.4772
Weight (kg), mean (SD)91.4 (12.7)87.1 (15.1)0.0011100.2 (20.7)95.9 (6.9)0.0241
BMI (kg/m2), mean (SD)35.5 (6.5)34.2 (7.1)0.018135.9 (6.8)34.2 (7.2)0.0381
HbA1c (mmol/L), median [IQR]
HbA1c (%), median [IQR]		8.4 [8.1, 10.5]
6.9 [6.7, 8.2]		8.2 [6.7, 10.6]
6.3 [5.8, 8.3]
0.0492		8.4 [8.1, 10.6]
6.9 [6.7, 8.3]		8.4 [6.9, 10.2]
6.9 [6.0, 8.0]
0.0902
Insulin Dose (IU/day), mean (SD)33.8 (19.9)30.7 (13.7)0.262138.4 (24.4)35.4 (19.2)0.1951
Total cholesterol (mg/dl), mean (SD)147.6 (36.1)133.5 (29.2)0.0111155.5 (32.3)140.6 (25.5)0.2511
LDL cholesterol (mg/dl), median [IQR]74.0 [49.3, 113.5]57 [45.0, 94.0]0.112285.0 [67.0, 114.0]60.0 [49.0, 75.0]0.0752
Triglycerides (mg/dl), mean (SD)144.5 (75.0)137.9 (50.4)0.7061141.1 (76.2)149.8 (51.6)0.1471
SBP (mmHg), mean (SD)138.9 (16.4)135.2 (17.6)0.2231147.0 (15.8)142.4 (11.5)0.3491
DBP (mmHg), mean (SD)77.8 (10.5)76.9 (10.2)0.133178.0 (13.4)79.9 (8.5)0.6141
Prednisone Dose (mg/day), median [IQR]5.0 [5.0, 5.0]5.0 [5.0, 5.0]0.18025.0 [5.0, 5.0]5.0 [5.0, 5.0]0.1802
Tacrolimus Dose (mg/day), median [IQR]3.0 [2.1, 4.2]3.0 [2.1, 4.8]0.13023.25 [3.0, 5.25]3.5 [3.0, 5.25]0.1172
Tacrolimus Trough Levels (ng/ml) mean (SD)6.3 (1.5)5.8 (1.9)0.42516.7 (1.4)7.3 (1.7)0.4751
Tacrolimus C/D Ratio, mean (SD)2.05 (0.9)1.8 (1.1)0.30711.7 (0.8)1.8 (1.0)0.1741

eGFR: Estimated Glomerular Filtration Rate, SD: Standard Deviation, IQR: Interquartile Range, UACR: Urine Albumin-to-Creatinine Ratio, BMI: Body Mass Index, SBP: Systolic Blood Pressure, DBP: Diastolic Blood Pressure, C/D: Concentration-Dose.

1

Paired sample t-test.

2

Paired Wilcoxon Signed Rank Test.

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© The Author(s) 2024. Published by Oxford University Press on behalf of the ERA.
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Issue Section:
E2 - EPIDEMIOLOGY & OUTCOME
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