Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists

Study Overview
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Brief Summary
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Patients with type 2 diabetes (T2D) suffer from an excess risk of adverse cardiovascular events. Recently, two classes of glucose lowering agents, namely SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA), have proved superior to placebo in protecting T2D patients from cardiovascular events in dedicated trials. Patient populations in such trials were mainly composed of T2D individuals with established cardiovascular disease (CVD) or at very high risk for CVD. In addition, no clinical trial has so far compared cardiovascular outcomes of T2D associated with SGLT2i versus GLP-1RA. In addition, whether different results would incur in patients at lower CVD risk is unclear. On this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with SGLT2i versus GLP-1RA in routine clinical practice

Official Title
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Cardiovascular Outcomes of Type 2 Diabetic Patients Treated With SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists in Real-life. An Observational Study Using Clinical-administrative Data

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SGLT2 inhibitor
* Drug: GLP-1 receptor agonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Italian citizens, residing in the Region Registered as beneficiaries for at least one year between January 1st, 2012 and September 30th, 2018 Diagnosis of type 2 diabetes Newly initiating SGLT-2 inhibitors or GLP-1 receptor agonists Being treated with glucose lowering medications before (at least one prescription of an antidiabetic agent in ATC class A10B prior to the index date) Time between the index date and the last SGLT2 inhibitors or GLP-1 receptor agonists prescription shorter than 8 months, Follow-up time or time-to-endpoint of at least three months Exclusion Criteria: Patients who started SGLT2i or GLP-1RA before 2014 Patients with an insufficient exposure time Patients with an incident event within three months after the index date.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SGLT2i<br>Patients who received new prescription of a SGLT-2 inhibitor | Drug: SGLT2 inhibitor<br>* New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice<br>|
| GLP-1RA<br>Patients who received new prescription of a GLP-1 receptor agonist | Drug: GLP-1 receptor agonist<br>* New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 point major adverse cardiovascular events (4P-MACE) | First occurrence of myocardial infarction, stroke, or death | 3-26 months after index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for cardiovascular causes | First hospitalization for any cardiovascular cause | 3-26 months after index date | 
| Death | All-cause death | 3-26 months after index date | 
| Myocardial infarction | Myocardial infarction | 3-26 months after index date | 
| Heart failure | Hospitalization for heart failure | 3-26 months after index date | 
| Stroke | Stroke or transient ischemic attack | 3-26 months after index date | 
| Revascularization | Any arterial site revascularization (surgical or endovascular) | 3-26 months after index date |