Tirzepatide and major adverse limb events: Insights from a multicenter real-world analysis in PAD and diabetes patients

Mar 6, 2025Diabetes research and clinical practice

Tirzepatide and serious limb problems in people with artery disease and diabetes: Findings from a large real-world study

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Abstract

Tirzepatide significantly reduced major adverse limb event (MALE) risk by 56% in patients with peripheral artery disease (PAD) and diabetes.

The hazard ratio for MALE risk with tirzepatide was 0.44, indicating a substantial reduction.
Tirzepatide was associated with lower all-cause mortality, stroke, and major adverse cardiovascular events.
Acute myocardial infarction risk showed no significant difference between tirzepatide and control groups.
Subgroup analyses confirmed the reduction in MALE risk, except for patients with a prior stroke.

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AIMS: Peripheral artery disease (PAD) is a major diabetic complication and a leading cause of amputation. While GLP-1 receptor agonists (GLP-1 RAs) provide cardiovascular and limb protection, the impact of tirzepatide, a dual GLP-1/GIP receptor agonist, on major adverse limb events (MALEs) remains unclear. This study assessed tirzepatide's association with MALE risk in patients with PAD and diabetes using real-world data.

METHODS: This retrospective cohort study analyzed 8,046 propensity score-matched PAD patients with diabetes (4,023 on tirzepatide, 4,023 controls) from the TriNetX database. The primary outcome was MALEs, with secondary outcomes including all-cause mortality, acute stroke, acute myocardial infarction (AMI), and major adverse cardiovascular events (MACEs). Cox models and Kaplan-Meier curves were used for analysis.

RESULTS: Tirzepatide significantly reduced MALE risk (HR: 0.44, 95 % CI: 0.33-0.59, p < 0.001) and was associated with lower mortality, stroke, and MACEs. AMI risk was similar between groups (HR: 0.85, p = 0.29). Subgroup analyses confirmed consistent findings, except in those with prior stroke.

CONCLUSIONS: Tirzepatide significantly lowered MALE risk in PAD patients with diabetes, suggesting a potential therapeutic role. Further prospective studies are needed to validate these findings.

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Tirzepatide and major adverse limb events: Insights from a multicenter real-world analysis in PAD and diabetes patients

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