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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 3 point major adverse cardiovascular events (4P-MACE)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
SGLT2i
Patients who received new prescription of a SGLT-2 inhibitor
干预措施: SGLT2 inhibitor (Drug)
GLP-1RA
Patients who received new prescription of a GLP-1 receptor agonist
干预措施: GLP-1 receptor agonist (Drug)
结局指标
主要结局
3 point major adverse cardiovascular events (4P-MACE)
时间窗: 3-26 months after index date
First occurrence of myocardial infarction, stroke, or death
次要结局
- 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)