Efficacy and Safety with Empagliflozin in Renal Transplant Recipients with Post-Transplant Diabetes Mellitus
1Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway, 2Department of Transplantation Medicine, Section of Nephrology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
Meeting: 2019 American Transplant Congress
Abstract number: 117
Keywords: Kidney transplantation, Post-transplant diabetes
Session Information
Date: Sunday, June 2, 2019
Session Name: Concurrent Session: Kidney: Cardiovascular and Metabolic I
Session Time: 4:30pm-6:00pm
Presentation Time: 4:30pm-4:42pm
Location: Ballroom C
*Purpose: Post-transplant diabetes mellitus (PTDM) is a highly prevalent condition following renal transplantation, associated with increased risk of cardiovascular disease and impaired patient survival. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have recently been shown not only to improve glycemia in patients with type 2 diabetes mellitus (T2DM), but also to protect against cardiovascular events in patients at high cardiovascular risk and to delay progressive impairment in glomerular filtration rate (GFR). The aim of this study was to investigate the safety and efficacy of using empagliflozin in renal transplant recipients with PTDM.
*Methods: From November 2016 to January 2018, 49 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. Renal transplant recipients transplanted >1 year ago, diagnosed with PTDM, stable renal function with eGFR >30 mL/min/1.73m2 and stable immunosuppressive therapy (tacrolimus/cyclosporine/everolimus in combination with mycophenolate and prednisolone) were eligible for inclusion. All variables were analyzed as median of differences in change from baseline to week 24 between the groups.
*Results: In total 44 renal transplant recipients (34 male, 10 female) completed the study. Median (IQR) change in HbA1c and fasting plasma glucose were significantly reduced after 24 weeks of empagliflozin treatment compared to placebo; -0.2 (-0.6, -0.1) vs 0.1 (-0.1, 0.4) % (P=0.002) and -0.7 (-1.2, -0.1) vs 0.3 (-0.5, 0.6) mmol/L (P=0.02) respectively. The treatment also resulted in a significant reduction in body weight -2.5 (-4.0, -0.1) compared to 1.0 (0.0, 2.0) kg in the placebo group (P=0.001). There were no significant differences between the groups in adverse events, trough levels of immunosuppressive drugs or eGFR after 24 weeks of treatment.
*Conclusions: Empagliflozin improves glycemic control compared to placebo after 24-week treatment with a concomitant reduction of body weight in stable renal transplant recipients. The treatment was well tolerated with no serious adverse events. Thus, empagliflozin seems to represents a novel treatment option for renal transplant recipients with PTDM.
To cite this abstract in AMA style:
Kvitne KE, Halden TS, Åsberg A, Midtvedt K, Hartmann A, Jenssen T. Efficacy and Safety with Empagliflozin in Renal Transplant Recipients with Post-Transplant Diabetes Mellitus [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-with-empagliflozin-in-renal-transplant-recipients-with-post-transplant-diabetes-mellitus/. Accessed April 15, 2021.« Back to 2019 American Transplant Congress