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Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus.

Authors :
Strøm Halden, Thea Anine
Kvitne, Kine Eide
Midtvedt, Karsten
Rajakumar, Laavanyaah
Robertsen, Ida
Brox, Jan
Bollerslev, Jens
Hartmann, Anders
Åsberg, Anders
Jenssen, Trond
Halden, Thea Anine Strøm
Source :
Diabetes Care; Jun2019, Vol. 42 Issue 6, p1067-1074, 8p
Publication Year :
2019

Abstract

<bold>Objective: </bold>Sodium-glucose cotransporter 2 (SGLT2) inhibitors have lately become the recommended treatment in patients with type 2 diabetes and high cardiovascular risk. Patients with posttransplant diabetes mellitus (PTDM) also have high cardiovascular risk. The aim of this study was to investigate the safety and efficacy of empagliflozin in renal transplant recipients with PTDM.<bold>Research Design and Methods: </bold>Forty-nine renal transplant recipients were included in an investigator-initiated, single-center, prospective, double-blind study and randomized to receive either 10 mg empagliflozin or placebo once daily for 24 weeks. Patients transplanted >1 year ago, diagnosed with PTDM, with stable renal function (estimated glomerular filtration rate [eGFR] >30 mL/min/1.73 m2), and with stable immunosuppressive therapy were studied.<bold>Results: </bold>Forty-four renal transplant recipients (22 empagliflozin/22 placebo, 34 males) completed the study. Median (interquartile range) change in glycated hemoglobin (HbA1c) was significantly reduced with empagliflozin compared with placebo: -0.2% (-0.6, -0.1) (-2.0 mmol/mol [-6.5, -1.0]) vs. 0.1% (-0.1, 0.4) (1.0 mmol/mol [-0.75, 3.8]) (P = 0.025). The magnitude of glucose reduction was dependent on GFR and baseline HbA1c. The treatment also resulted in a significant reduction in body weight of -2.5 kg (-4.0, -0.05) compared with an increase of 1.0 kg (0.0, 2.0) in the placebo group (P = 0.014). There were no significant differences between the groups in adverse events, immunosuppressive drug levels, or eGFR.<bold>Conclusions: </bold>Empagliflozin appeared safe and improved glycemic control in renal transplant recipients with PTDM compared with placebo. A concomitant reduction in body weight was seen. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01495992
Volume :
42
Issue :
6
Database :
Complementary Index
Journal :
Diabetes Care
Publication Type :
Academic Journal
Accession number :
136545231
Full Text :
https://doi.org/10.2337/dc19-0093