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Abstract: SA-PO260

Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With CKD and Type 2 Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical


  • Fu, Edouard, Brigham and Women's Hospital, Boston, Massachusetts, United States
  • D'Andrea, Elvira, Brigham and Women's Hospital, Boston, Massachusetts, United States
  • Wexler, Deborah J., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Patorno, Elisabetta, Brigham and Women's Hospital, Boston, Massachusetts, United States
  • Paik, Julie M., Brigham and Women's Hospital, Boston, Massachusetts, United States

CREDENCE and DAPA-CKD showed the renal and cardiovascular efficacy of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with chronic kidney disease (CKD). However, limited information exists about the safety of SGLT2i in routine clinical practice, which may contribute to their slow uptake. We evaluated the comparative safety of SGLT2i versus glucagon-like peptide 1 receptor agonist (GLP-1RA) or the dipeptidyl peptidase 4 (DPP-4) inhibitor sitagliptin among patients with CKD and type 2 diabetes (T2D) in routine care.


We conducted a population-based cohort study using two commercial and Medicare claims databases (April 2013-December 2021). We included patients with a diagnosis of stage 3-4 CKD and T2D initiating a SGLT2i or a comparator, i.e., GLP-1RA or sitagliptin. New users of SGLT2i were 1:1 propensity score matched to new users of GLP-1RA (cohort 1) or sitagliptin (cohort 2) in two pairwise comparisons, accounting for more than 120 baseline characteristics. Safety outcomes were diabetic ketoacidosis hospitalization, lower limb amputations, genital infections, hyperkalemia, acute kidney injury (AKI), non-vertebral fractures, hypovolemia, severe hypoglycemia, and severe urinary tract infections (UTI).


Cohort 1 included 28,847 matched pairs initiating SGLT2i or GLP-1RA (mean age 72 years, 44% female). Compared with GLP-1RA, SGLT2i had similar risks for diabetic ketoacidosis, hypovolemia, hypoglycemia and severe UTI, increased risks for lower limb amputation and genital infections, and lower risks for hyperkalemia and AKI (Table). We observed similar findings in cohort 2 among 19,342 matched pairs of patients initiating SGLT2i or sitagliptin.


In U.S. patients with CKD and T2D from routine care, with older mean age than those in RCTs, SGLT2i are associated with increased risks of lower limb amputations, genital infections, and potentially non-vertebral fractures, and with lower risks of hyperkalemia and acute kidney injury. No differences were observed for diabetic ketoacidosis, hypovolemia, and hypoglycemia.


  • Other U.S. Government Support