A Prospective Observational Study to Assess the Efficacy of a SGLT2 Inhibitor (Dapagliflozin) in Kidney Allograft Recipients with Diabetes Mellitus

Background: Cardiovascular disease is a major cause of graft loss and mortality in renal transplant patients, who may be benefited from SGLT2 inhibitors. But, they are not routinely recommended and few studies of their use in renal transplant patients have been published. Methods: In this 12 months study, 100 renal transplant patients with both pre-existing and post transplant diabetes mellitus, visiting out patient department, were included. Half of them received dapagliflozin 10mg along with their ongoing anti-diabetic medicines and the others continued their already ongoing medicines, with dose adjustment according to HbA1c. Fasting and post-prandial blood glucose, glycated hemoglobin (HbA1c) and creatinine and urine for routine examination and albumin-creatinine ratio (ACR) were tested at baseline and at 3, 6 and 12 months during routine follow-up visit. Results: There was no significant statistical difference in the mean reduction of HbA1c (0.72% in dapa group, 0.86% in non-dapa group), as well as mean reduction of urine ACR between the 2 groups. No significant change in eGFR was found at 12 months. There was no episode of acute kidney injury observed, other than in patients requiring hospitalization. The frequency of urinary tract infection (UTI) (12% in both the groups) as well as genital infections were not statistically different (8% in dapa group, 6% in non-dapa group). Dapagliflozin was discontinued in 4% patients with UTI, for recurrence, but none in those with genital infections. No patient suffered rejection, ketoacidosis or hypotension. Conclusion: Dapagliflozin lead to a modest reduction of HbA1c, but had less potent anti-proteinuric action. It was not associated with significant allograft dysfunction, and had similar frequency of adverse effects like that of other anti-diabetic medications. Funding: Clinical Revenue Support