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Risk of leg amputations in people with type 2 diabetes treated with SGLT2 inhibitors in the USA
Updated
Abstract
The incidence rate of below-knee lower extremity amputation was 1.18 events per 1000 person-years for new users of canagliflozin.
- Among 118,018 new users of SGLT2 inhibitors, including 73,024 on canagliflozin, the incidence rates of BKLE amputation were 1.22 for SGLT2 inhibitors, 1.26 for canagliflozin, and 1.87 for non-SGLT2 inhibitor antihyperglycaemic agents.
- In a matched comparison of 63,845 users each of canagliflozin and non-SGLT2 inhibitor AHAs, the incidence rates of BKLE amputation were 1.18 and 1.12 events per 1000 person-years, respectively.
- The hazard ratio for BKLE amputation between canagliflozin and non-SGLT2 inhibitor AHAs was 0.98, indicating no significant difference in risk.
- P values and calibrated P values showed no evidence of increased risk of BKLE amputation associated with canagliflozin use compared to non-SGLT2 inhibitor AHAs.
Simplified
Key numbers
1.22 per 1000 person-years
Crude Incidence Rate of BKLE Amputation (SGLT2 inhibitors)
Incidence rate for patients using SGLT2 inhibitors.
1.26 per 1000 person-years
Crude Incidence Rate of BKLE Amputation (Canagliflozin)
Incidence rate for patients using canagliflozin.
0.98
Hazard Ratio for BKLE Amputation (Canagliflozin vs. Non-SGLT2 AHAs)
Comparative analysis of amputation risk between canagliflozin and non-SGLT2 inhibitors.