DRUG
SGLT2 inhibitor
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists
Status
Completed
Phase
Not applicable
Enrollment
10,000
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
GLP-1 receptor agonist
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice
Timeline
From registration to results.
First posted
Dec 4, 2019
Study start
Mar 1, 2014
Primary completion
Dec 31, 2018
Study completion
Feb 29, 2020
Results posted
Not reported
Registry updated
Mar 11, 2020
Outcomes
What the study measures.
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
Hospitalization for cardiovascular causes
Time frame · 3-26 months after index date
First hospitalization for any cardiovascular cause
Death
Time frame · 3-26 months after index date
All-cause death
Myocardial infarction
Time frame · 3-26 months after index date
Myocardial infarction
Heart failure
Time frame · 3-26 months after index date
Hospitalization for heart failure
Stroke
Time frame · 3-26 months after index date
Stroke or transient ischemic attack
Revascularization
Time frame · 3-26 months after index date
Any arterial site revascularization (surgical or endovascular)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Sex
- ALL
- Healthy volunteers
- Not reported
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.
Study locations
1 registered sites.
Italy. Showing up to 24 locations stored in the fast local snapshot.
Division of Metabolic Diseases, University Hospital of Padova
Padova, Italy
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
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