SGLT2 Inhibitor Does Not Increase Amputation Risk
Empagliflozin, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, was not associated with an increased risk for lower limb amputation (LLA) among patients with type 2 diabetes, according to a recent study.
The researchers conducted a post-hoc analysis of the EMPA-REG OUTCOME trial using serious adverse event reports to identify cases of LLA. They calculated the time to first LLA event, the frequency, incidence rate, and incidence rate ratios for LLA in all patients and patient subgroups created using baseline characteristics associated with the risk for amputation.
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In the EMPA-REG trial, a total of 7020 patients were randomly assigned to either empagliflozin or placebo. The mean age was 63.1 years, the mean body mass index was 30.6 kg/m2, the mean HBA1c was 8.1%, 11% had peripheral artery occlusive disease, 57% were diagnosed with type 2 diabetes and had a disease duration of .10 years, and 48% were taking insulin at baseline.
During the median 3.1 years of follow-up, 131 patients underwent LLAs, with 88 patients (1.9%) in the empagliflozin group and 43 patients (1.8%) in the placebo group.
The researchers found that the time to first LLA was similar in the pooled empagliflozin group and placebo group. Additionally, both groups had a similar incidence rate of 6.5 persons per 1000 patient-years.
“In conclusion, the SGLT2 inhibitor empagliflozin was not associated with an increased risk of LLA compared with placebo in the EMPA-REG OUTCOME trial,” the researchers concluded.
—Melissa Weiss
Reference:
Inzucchi SE, Iliev H, Pfarr E, Zinman B. Empagliflozin and assessment of lower-limb amputations in the EMPA-REG OUTCOME Trial [published online November 13, 2017]. Diabetes Cares. https://doi.org/10.2337/dc17-1551.