SGLT2 inhibitors do not pose fracture risk

The use of sodium-glucose cotransporter 2 inhibitors (SGLT2i), either alone or in combination with other glucose-lowering medications (GLM), does not seem to exacerbate the risk of sustaining fractures, a new study has found.

Researchers conducted a retrospective and observational pharmacovigilance study in a real-world setting, drawing from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality and Bayesian analyses were used to see if fracture-related adverse events occurred more frequently in patients receiving SGLT2is between 2004 and 2019.

In the nearly 15 years’ worth of data, the FAERS database reported a total of 44,558 adverse events related to SGLT2is, along with 169,132 incidents related to fractures. Ultimately, 317 fracture reports were deemed to be related to SGLT2i use.

Most of the treatment-associated fracture cases happened in male patients (58.04 percent) and in patients older than 45 years (68.76 percent). Canagliflozin (51.10 percent), dapagliflozin (24.60 percent), and empagliflozin (23.66 percent) were the most common drugs implicated in these fractures.

Statistical analyses detected no positive signals from SGLT2i use alone or in combination with other GLMs. In terms of outcomes, 66.64 percent of SGLT2i-related fractures required hospitalization, while 9.38 percent ended in death.

“The predictable increase in the number of patients who will receive SGLT2is in the future implies that close monitoring and constant epidemiological surveillance are needed even if the adverse event of fracture occurs rarely,” the researchers said. “It is still recommended to include fractures in postmarketing risk management plans.”