Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 887,132
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide)
研究概览
简要总结
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of
- Tirzepatide vs dulaglutide,
- Semaglutide vs sitagliptin,
- Tirzepatide vs semaglutide
on cardiovascular outcomes in individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes (T2DM) and overweight but might not meet the eligibility criteria of pivotal RCTs for each drug (SUSTAIN-6 and SURPASS-CVOT trials), used to support regulatory approval in patients at cardiovascular risk.Although many features of the target trials cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
The three database studies will be new-user active-comparative studies, conducted using 3 national United States claims databases, where investigators compare the effect of semaglutide vs sitagliptin (used as an active comparator placebo proxy), tirzepatide vs dulaglutide, and tirzepatide vs semaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both tirzepatide and semaglutide for the same indications of glucose lowering and weight reduction.
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
- •History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
- •Type 2 diabetes
- •BMI ≥25.0kg/m2
- •Age ≥18 years
- •Male or female sex
排除标准
- •Medullary thyroid carcinoma, MEN syndrome type 2
- •Malignancy
- •Type 1 diabetes or secondary diabetes
- •Chronic kidney disease or dialysis
- •Uncontrolled diabetic retinopathy or maculopathy
- •Pregnancy
- •Prior use of pramlintide or any GLP-1-RA or DPP4i
- •ELIGIBILITY FOR TIRZEPATIDE VS SEMAGLUTIDE
- •Inclusion Criteria:
- •History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension
- •Type 2 diabetes
- •BMI ≥25.0kg/m2
- •Age ≥18 years
- •Male or female sex
- •Exclusion Criteria:
- •Medullary thyroid carcinoma, MEN syndrome type 2
- •Malignancy
- •Type 1 diabetes or secondary diabetes
- •Chronic kidney disease or dialysis
- •Uncontrolled diabetic retinopathy or maculopathy
- •Pregnancy
- •Prior use of pramlintide or any GLP-1-RA
研究组 & 干预措施
Cohort 1
Tirzepatide vs dulaglutide
干预措施: Tirzepatide (Drug)
Cohort 1
Tirzepatide vs dulaglutide
干预措施: Dulaglutide (Drug)
Cohort 2
Semaglutide vs sitagliptin
干预措施: Semaglutide (Drug)
Cohort 2
Semaglutide vs sitagliptin
干预措施: Sitagliptin (Drug)
Cohort 3
Tirzepatide vs semaglutide
干预措施: Tirzepatide (Drug)
Cohort 3
Tirzepatide vs semaglutide
干预措施: Semaglutide (Drug)
结局指标
主要结局
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide)
时间窗: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of tirzepatide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Composite of all-cause mortality, myocardial infarction or stroke (Injectable semaglutide vs sitagliptin)
时间窗: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs injectable semaglutide)
时间窗: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of tirzepatide vs semaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.
次要结局
- Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs dulaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Urinary tract infections (Tirzepatide vs dulaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Serious bacterial infections (Tirzepatide vs dulaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Injectable semaglutide vs sitagliptin)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Gastrointestinal adverse events (Tirzepatide vs dulaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Injectable semaglutide vs sitagliptin)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Urinary tract infections (Injectable semaglutide vs sitagliptin)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Gastrointestinal adverse events (Injectable semaglutide vs sitagliptin)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Serious bacterial infections (Injectable semaglutide vs sitagliptin)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs injectable semaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs injectable semaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Urinary tract infections (Tirzepatide vs injectable semaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Serious bacterial infections (Tirzepatide vs injectable semaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
- Gastrointestinal adverse events (Tirzepatide vs injectable semaglutide)(1 day after cohort entry date until the first of outcome or censoring, up to 365 days)
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital