Risk of Lower Extremity Amputations in Patients With Type 2 Diabetes Mellitus Using SGLT2 Inhibitors

September 12, 2017. This retrospective, real-world study evaluated the risk of below-knee lower extremity (BKLE) amputation among patients with type 2 diabetes taking any sodium glucose co-transporter 2 (SGLT-2) inhibitor (118,018 patients total), including 73,024 patients taking canagliflozin. Researchers compared the incidence of BKLE among these patients compared with 226,623 patients taking antihyperglycemic agents (AHAs) other than SGLT-2 inhibitors. All patients included in the study were using SGLT-2 inhibitors or other AHAs for the first time. Between April 1, 2013, and October 31, 2016, the crude incidence rate of BKLE amputation was 1.26, 1.22, and 1.87 events per 1,000 person-years with canagliflozin, SGLT-2 inhibitors, and other AHAs, respectively. Researchers then compared 63,845 canagliflozin users with 63,845 other-AHA users who had similar baseline characteristics. Per 1,000 person-years, the incidence rate of BKLE amputation was 1.18 and 1.12 events with canagliflozin and other-AHA users, respectively. The difference in risk of BKLE amputation between the two groups (2%) was not statistically significant. Based on this, researchers found no increased risk of BKLE amputation for new canagliflozin users compared to new users of non-SGLT-2-inhibitor AHA users. Read the study abstract here.