Use of SGLT2i Versus DPP-4i as an Add-on Therapy and the Risk of PAD-Related Surgical Events (Amputation, Stent Placement, or Vascular Surgery): A Cohort Study in Veterans With Diabetes

Feb 20, 2025Diabetes care

Risk of Limb-Related Surgeries with SGLT2 Inhibitors Compared to DPP-4 Inhibitors as Additional Diabetes Treatment in Veterans

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Abstract

There were 874 peripheral artery disease (PAD) events among 76,072 users of sodium-glucose cotransporter 2 inhibitors (SGLT2is).

The event rate for PAD was 11.2 per 1,000 person-years for SGLT2i users.
Dipeptidyl peptidase 4 inhibitors (DPP-4is) had a lower event rate of 10.0 per 1,000 person-years.
The adjusted hazard ratio for PAD events in SGLT2i users compared to DPP-4i users was 1.18.
When considering PAD events up to 360 days after stopping SGLT2is, the adjusted hazard ratio was 1.16.
SGLT2is may be associated with an increased risk of PAD surgical outcomes compared to DPP-4is.

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OBJECTIVE: To compare the risk of composite peripheral artery disease (PAD) surgical outcome, including peripheral revascularization and amputation procedures, between new users of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP-4is).

RESEARCH DESIGN AND METHODS: This retrospective cohort study of U.S. veterans age ≥18 years with diabetes who received care from the Veterans Health Administration was performed from 1 October 2000 to 31 December 2021. Data were linked to Medicare, Medicaid, and the National Death Index. New use of SGLT2i or DPP-4i medications as an add-on to metformin, sulfonylurea, or insulin treatment alone or in combination was evaluated for an association with PAD surgical procedure for peripheral revascularization and amputation. A Cox proportional hazards model for time-to-PAD event analysis compared the risk of a PAD event between SGLT2is and DPP-4is in a propensity score-weighted cohort with a competing risk of death and allowance for events to occur up to 90 days or 360 days after stopping SGLT2is.

RESULTS: The weighted cohort included 76,072 SGLT2i vs. 75,833 DPP-4i use episodes. The median age was 69 years, HbA1c was 8.4% (interquartile range [IQR] 7.5-9.4%), and the median diabetes duration was 10.1 (IQR 6.6-14.6) years. There were 874 and 780 PAD events among SGLT2i and DPP-4i users, respectively, for an event rate of 11.2 (95% CI 10.5-11.9) and 10.0 (9.4-10.6) per 1,000 person-years (adjusted hazard ratio [aHR] 1.18 [95% CI 1.08-1.29]). When PAD events were allowed for 360 days after SGLT2i use ended, the aHR was 1.16 (95% CI 1.06-1.26).

CONCLUSIONS: SGLT2i as an add-on diabetes therapy was associated with an increased cause-specific hazard of PAD surgeries compared with DPP-4i.

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Use of SGLT2i Versus DPP-4i as an Add-on Therapy and the Risk of PAD-Related Surgical Events (Amputation, Stent Placement, or Vascular Surgery): A Cohort Study in Veterans With Diabetes

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