Type 2 Diabetes
Conditions
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
Interventions
DRUGSGLT2 inhibitor
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
DRUGGLP-1 receptor agonist
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice
Sponsors
University of Padova
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 point major adverse cardiovascular events (4P-MACE) | 3-26 months after index date | First occurrence of myocardial infarction, stroke, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for cardiovascular causes | 3-26 months after index date | First hospitalization for any cardiovascular cause |
| Death | 3-26 months after index date | All-cause death |
| Myocardial infarction | 3-26 months after index date | Myocardial infarction |
| Stroke | 3-26 months after index date | Stroke or transient ischemic attack |
| Revascularization | 3-26 months after index date | Any arterial site revascularization (surgical or endovascular) |
| Heart failure | 3-26 months after index date | Hospitalization for heart failure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | 3-26 months after index date | Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury |
Countries
Italy
Outcome results
None listed