SGLT2i treatment correlates with higher risks among patients with CKD, type 2 diabetes
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Key takeaways:
- Patients with type 2 diabetes and chronic kidney disease experience increased risk for genital infections when taking SGLT2i.
- STGLT2i showed lower risks of AKI.
Compared with glucagon-like peptide-1 receptor agonists, patients with chronic kidney disease and type 2 diabetes experienced increased risks when taking SGLT2 inhibitors, according to published data.
“Currently, there is a paucity of safety data on SGLT2i in patients with CKD and type 2 diabetes. Clinical trials are generally underpowered to assess rare but potentially severe side effects. They also include highly selected patient populations with different characteristics from those who receive SGLT2i in routine care and apply monitoring protocols to lower the risk of adverse effects which may not be adopted in routine practice,” Edouard L. Fu, PhD, from Brigham and Women’s Hospital and Harvard Medical School, and colleagues wrote. “We therefore aimed to comprehensively investigate the safety profile of SGLT2i in routinely cared patients with CKD and type 2 diabetes using three nationwide U.S. databases.”
In an active-comparator, new-user cohort study, researchers examined 96,128 adults with stages 3 to 4 CKD and type 2 diabetes who filled prescriptions for SGLT2i or glucagon-like peptide-1 receptor agonists (GLP-1RA) within a year of enrollment. Data were derived from two large U.S. commercial and Medicare databases between April 2023 and December 2021.
With a filled prescription serving as the exposure, researchers considered diabetic ketoacidosis, lower limb amputations, nonvertebral fractures, genital infections, hypovolemia, AKI, hypoglycemia and severe urinary tract infections (UTIs) as the safety outcomes. Researchers identified propensity score-matched numbers of events, incidence rates, incidence rate differences and HRs.
Overall, patients who started a SGLTi experienced an increased risk for nonvertebral fractures (incidence rate of 2.13), lower limb amputations (incidence rate of 1.65) and genital infections (incidence rate of 3.08), compared with those who started a GLP-1RA. Researchers observed similar risks of diabetic ketoacidosis, hypovolemia, hypoglycemia and severe UTIs, but STGLT2i showed lower risks of AKI.
“Our study can help inform patient-physician decision-making regarding risks and benefits before prescribing SGLT2i in this population, but need[s] to be interpreted in light of its limitations, including residual confounding, short follow-up time and the use of diagnosis codes to identify CKD patients,” Fu and colleagues wrote.
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