Background: Post Transplant Diabetes Mellitus (PTDM) is a common complication following heart transplantation and is associated with increased long-term morbidity and mortality. PTDM is becoming an increasingly large problem, as 37% of transplant recipients are diagnosed with PTDM within 5 years post transplantation. Empagliflozin was the first anti-hyperglycaemic drug to show a significant reduction in major cardiovascular events, hospitalisations for heart failure and all-cause mortality in the patients with Type 2 diabetes mellitus. However the safety and efficacy of empagliflozin use for the management of PTDM is yet to be established.
Methods: A retrospective observational study of patients attending a heart transplant clinic. Diabetic patients treated with empagliflozin were compared to a control group receiving alternative diabetes treatment and clinical outcomes were examined.
Results: Among 101 patients with PTDM, a total of 22 patients were treated with empagliflozin (total cumulative treatment 319 months). Overall the drug was well tolerated with only 3 minor adverse events were recorded and there were no instances of genitourinary infections. There was a significant reduction in weight (4.4 ±5.5 kg [p = 0.008])BMI (1.5 ±1.9 kg/m2 [p=0.007]) and frusemide dose (68 ± 109 mg [p=0.031]) after 12 months of treatment in the empagliflozin group that was not seen in the control group. Trends of reduced HbA1c (0.41%) and blood pressure (Systolic 4.3 mmHg and diastolic 1.1 mmHg) were also seen. Whilst these results not significant due to the study being underpowered, the absolute values exceeded those seen in the EMPA-REG study. There were no significant changes in serum urea, or creatinine levels, eGFR or haemoglobin associated with empagliflozin treatment.
Conclusions: Empagliflozin appears to be safe for use in the long-term management of PTDM following heart transplantation. There may also be a range of metabolic benefits, additional to glucose control, associated with this treatment. As SGLT-2 inhibitors such as empagliflozin have been shown to decrease mortality in patients with Type 2 diabetes mellitus, the use of SGLT-2 inhibitors in the management of PTDM warrants further investigation, given the theoretical potential benefits arising with use in this population.