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Small Fournier gangrene risk with SGLT-2 inhibitors should not influence prescribing decisions

For men with type 2 diabetes, the small increased risk for Fournier gangrene associated with SGLT-2 inhibitor treatment should not dissuade clinicians from prescribing them, according to a research letter published in JAMA Internal Medicine.

“Fournier gangrene — a fulminant necrosis of the fascia surrounding the genitals and perineum — is a rare and often fatal urologic emergency that disproportionally affects men at a 10:1 ratio,” Chintan V. Dave, PharmD, PhD, of the department of medicine at Brigham and Women’s Hospital in Boston, and colleagues wrote. “Case reports linking Fournier gangrene with the use of SGLT-2 inhibitors prompted a U.S. Food and Drug Administration warning in August 2018.”

Researchers evaluated the association between risk for hospitalization with Fournier gangrene and initiation of SGLT-2 inhibitor treatment.

Using two commercial claims databases and Medicare fee-for-service data, they conducted a cohort study of men with type 2 diabetes who initiated treatment with either an SGLT-2 inhibitor (n = 138,158) or a DPP-4 inhibitor (n = 360,685) within the previous 180 days. The researchers also performed a sensitivity analysis in which SGLT-2 inhibitors were compared with a GLP-1 agonist.

Researchers found that Fournier gangrene occurred “rarely” among patients initiating treatments for type 2 diabetes.

Among the SGLT-2 inhibitor users, the unadjusted incidence rate for hospitalization was 15 per 100,000 person-years compared with 9.7 for those who used DPP-4 inhibitors (adjusted rate difference of 6.7 excess hospitalizations; 95% CI, –2.8 to 16.1).

When the comparator was changed to a GLP-1 agonist, researchers found that the adjusted rate difference was 9.7 excess hospitalizations per 100,000 person-years (95% CI, 0.1-19.2).

“Among those men initiating use of an SGLT-2 inhibitor, the study found a potential increase of approximately 1 case per 10,000 men treated, but this increase was not statistically significant,” the researchers wrote. “The findings suggest that the small increase in the risk of Fournier gangrene that may be associated with SGLT-2 inhibitor treatment should not influence the prescribing decisions of these agents in light of other benefits of treatment.” – by Melissa J. Webb

Disclosures: Dave reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.