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
Overview
- Phase
- Not Applicable
- Intervention
- SGLT2 inhibitor
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Padova
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- 3 point major adverse cardiovascular events (4P-MACE)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
SGLT2i
Patients who received new prescription of a SGLT-2 inhibitor
Intervention: SGLT2 inhibitor
GLP-1RA
Patients who received new prescription of a GLP-1 receptor agonist
Intervention: GLP-1 receptor agonist
Outcomes
Primary Outcomes
3 point major adverse cardiovascular events (4P-MACE)
Time Frame: 3-26 months after index date
First occurrence of myocardial infarction, stroke, or death
Secondary Outcomes
- Revascularization(3-26 months after index date)
- Hospitalization for cardiovascular causes(3-26 months after index date)
- Death(3-26 months after index date)
- Myocardial infarction(3-26 months after index date)
- Heart failure(3-26 months after index date)
- Stroke(3-26 months after index date)