Empagliflozin and Assessment of Lower-Limb Amputations in the EMPA-REG OUTCOME Trial
Abstract
Sodium–glucose cotransporter 2 (SGLT2) inhibitors are oral glucose-lowering agents indicated for the treatment of type 2 diabetes. In the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, the SGLT2 inhibitor canagliflozin was associated with an increased risk for lower-limb amputation (LLA) (including minor and major amputation) versus placebo (hazard ratio [HR] 1.97 [95% CI 1.41, 2.75]) in patients with type 2 diabetes and high cardiovascular risk (1). In the EMPA-REG OUTCOME trial in patients with type 2 diabetes and established cardiovascular disease (2), the proportion of patients with LLA was similar between those treated with empagliflozin and placebo (3). We report further analyses of LLA in the EMPA-REG OUTCOME trial.
Any hospital admission during the EMPA-REG OUTCOME trial was to be reported as a serious adverse event. Investigators were asked to provide a detailed narrative with additional medical information for each serious adverse event. From the EMPA-REG OUTCOME trial database, we identified LLA via a systematic search of serious adverse event narratives, from events reported as adverse events, and from those reported as a “medical procedure” under “concomitant therapy” in electronic case report forms or in investigator comments describing adverse events. All cases identified were medically reviewed to confirm an LLA event. Time to first LLA was analyzed using a …
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