SGLT2i Use in France Based on SNDS Data Claim
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 547,150
- 试验地点
- 1
- 主要终点
- Baseline characteristic: Age
研究概览
简要总结
The primary objective of this study are:
- Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments.
The secondary objectives are:
- Assess the occurrence of atheromatous cardiovascular events (unstable angina, fatal and non-fatal Myocardial infarction (MI), Transient ischemic attack (TIA), fatal and non-fatal stroke), deaths from all causes, hospitalization for heart failure and hospitalization for end-stage renal disease as main and related diagnoses during the exposure to the studied treatment
- Assess the occurrence of the main safety events (ketoacidosis, lower limb amputation and Fournier's gangrene) during the exposure to the studied treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
排除标准
- 未提供
研究组 & 干预措施
Type 2 diabetes mellitus patients initiating SGLT2i
干预措施: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug)
Patients initiating treatment with SGLT2i
干预措施: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug)
结局指标
主要结局
Baseline characteristic: Age
时间窗: up to 5 years
Baseline characteristic: Type of diabetes
时间窗: up to 5 years
Baseline characteristic: Gender
时间窗: up to 5 years
Proportion of patients with a history of cardio-vascular events including heart failure hospitalizations and lower limb amputation, renal events, ketoacidosis, Fournier's gangrene over the two years before the index date (initiation of SGLT2i)
时间窗: up to 5 years
Baseline characteristic: Region of residence
时间窗: up to 5 years
Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)
时间窗: up to 5 years
次要结局
- Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i(up to 5 years)
- Time from drug initiation to first event of acute cardiovascular atheromatous events(up to 5 years)
- Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i(up to 5 years)
- Time from drug initiation to first event of heart failure hospitalization(up to 5 years)
- Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i(up to 5 years)
- Time from drug initiation to death all cause(up to 5 years)