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

NCT ID: NCT07198191

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2026-08-30

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

SGLT2 Inhibitor Group

Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction.

SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)

Intervention Type: DRUG

Exposure to SGLT2 inhibitors following AMI in patients with T2DM

DPP4 Inhibitor Group

Patients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction.

DPP4 inhibitors

Intervention Type: DRUG

Exposure to DPP4 inhibitors following AMI in patients with T2DM

Interventions

SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)

Exposure to SGLT2 inhibitors following AMI in patients with T2DM

Intervention Type: DRUG

DPP4 inhibitors

Exposure to DPP4 inhibitors following AMI in patients with T2DM

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥19 years
• Hospitalization with a primary diagnosis of acute myocardial infarction between September 2014 and June 2021
• Diagnosis of type 2 diabetes mellitus (T2DM)
• Prescription of either an SGLT2 inhibitor or a DPP4 inhibitor after index AMI

Exclusion Criteria

• Diagnosis of type 1 diabetes mellitus
• Gestational diabetes mellitus
• End-stage renal disease (ESRD) or history of kidney transplantation
• No use of either SGLT2 inhibitor or DPP4 inhibitor after index AMI
• Short-term use of SGLT2 inhibitor or DPP4 inhibitor (less than 30 days)
• Concomitant use of SGLT2 inhibitor and DPP4 inhibitor
• Incomplete or missing data for key study variables

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical Corp.

INDUSTRY

Sponsor Role: collaborator

Health Insurance Review & Assessment Service

UNKNOWN

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yongcheol Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongcheol Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Yongin Severance Hospital

Locations

Yongin Severance Hospital, Yonsei University Health System

Yongin, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

IRB No. 9-2023-0049

Identifier Type: -

Identifier Source: org_study_id