NCT07198191

SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study

Impact of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Population Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200,000 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This observational, retrospective cohort study aims to evaluate the impact of sodium-glucose cotransporter 2 (SGLT2) inhibitor use after acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus (T2DM). Using the nationwide database from the Korean National Health Insurance Service, the investigators will compare cardiovascular outcomes between patients treated with SGLT2 inhibitors and those treated with dipeptidyl peptidase-4 (DPP4) inhibitors after AMI. The study period includes patients diagnosed with AMI between September 2014 and June 2021, with follow-up data available through June 2022. The primary outcomes include major cardiovascular events (death, myocardial infarction, stroke) and bleeding events. This study will provide real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea.

Detailed description

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated substantial cardiovascular benefits in patients with heart failure and chronic kidney disease, independent of glucose-lowering effects. However, their role in patients with acute myocardial infarction (AMI), particularly in the early post-infarction period, has been less clear. Recently, the DAPA-MI and EMPACT-MI randomized controlled trials have provided important insights. In DAPA-MI, approximately 1 year of dapagliflozin therapy in patients with recent AMI improved cardiometabolic outcomes but did not reduce the composite endpoint of cardiovascular death or hospitalization for heart failure compared with placebo. Similarly, in EMPACT-MI, treatment with empagliflozin among high-risk patients following AMI did not significantly lower the risk of first hospitalization for heart failure or all-cause death compared with placebo. These findings highlight the need for complementary large-scale real-world data to further clarify the clinical utility of SGLT2 inhibitors in this population. This investigator-initiated observational cohort study utilizes de-identified claims data from the Korean National Health Insurance Service (NHIS) to evaluate clinical outcomes associated with SGLT2 inhibitor use in patients with type 2 diabetes mellitus (T2DM) after AMI. The study population includes adult patients (≥19 years) hospitalized with AMI (ICD-10 codes I21-I23) between September 2014 and June 2021. Patients are stratified based on use of SGLT2 inhibitors versus dipeptidyl peptidase-4 (DPP4) inhibitors following the index event. Exclusion criteria include prior SGLT2 inhibitor use within 12 months before AMI, malignancy, cardiogenic shock, or missing ICD-10 data. Outcomes of interest include major adverse cardiovascular events (all-cause mortality, cardiovascular death, recurrent MI, ischemic stroke) and bleeding events (major bleeding, site-specific bleeding, transfusion). Propensity-score matching is performed to adjust for baseline demographic and clinical characteristics. Kaplan-Meier survival curves and Cox proportional hazards models are used to estimate hazard ratios for outcomes. The primary endpoint is the incidence of major adverse cardiovascular events (MACE). Secondary endpoints include individual cardiovascular events, hospitalization for heart failure, and bleeding events. Subgroup analyses assess outcomes according to comorbid chronic heart failure, chronic kidney disease, and concomitant thiazolidinedione therapy. This study provides real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea, thereby complementing randomized trial data and informing guideline recommendations for this high-risk population.

Conditions

• Acute Myocardial Infarction (AMI)
• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)	Exposure to SGLT2 inhibitors following AMI in patients with T2DM
DRUG	DPP4 inhibitors	Exposure to DPP4 inhibitors following AMI in patients with T2DM

Timeline

• Start date: 2014-09-01
• Primary completion: 2022-06-30
• Completion: 2026-08-30
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: South Korea