Comparative Study of Tirzepatide vs Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70,000
- 试验地点
- 2
- 主要终点
- Composite CV outcome
研究概览
简要总结
This cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data.
详细描述
Recent evidence suggests that the metabolic effects of glucagon-like peptide-1 receptor agonists (GLP-1RA) can be enhanced by combining them with the actions of other entero-pancreatic hormones, such as glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon. Tirzepatide is a once-weekly GIP/GLP-1RA, approved for the treatment of type 2 diabetes in May 2022.
The Study of Tirzepatide Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT; NCT04255433) is an event-driven, randomized, double- blind, active comparator, parallel-group study, to evaluate cardiovascular (CV) outcomes with tirzepatide treatment in people with type 2 diabetes (T2D) and established atherosclerotic CV disease (ASCVD) compared with dulaglutide treatment, stratified by baseline sodium-glucose cotransporter-2 (SGLT2) inhibitors use. SURPASS-CVOT was designed to establish CV protection with tirzepatide by demonstrating noninferiority of tirzepatide to dulaglutide, and also to determine whether tirzepatide produces a greater CV benefit than dulaglutide (superiority analysis).
This new user active comparator cohort study aims to emulate the SURPASS-CVOT trial using insurance claims data. Trial design parameters were adapted in claims data using observational analogues for eligibility criteria, treatment strategies, treatment assignment, follow-up start, follow-up end, outcome, and causal contrast. We also conducted HbA1c-adjusted analyses among those with HbA1c values (54% of population).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2D who were new users of tirzepatide or new users of dulaglutide
- •AND established ASCVD defined as:
- •History of Myocardial Infarction (MI) or MI sequela
- •Unstable or stable angina
- •Coronary atherosclerosis disease or procedures
- •Ischemic stroke
- •Peripheral arterial disease or procedures
- •Atherosclerotic cerebrovascular disease or cerebrovascular procedures
- •Lower-limb amputation
- •Age >= 40 years old
- •Patients with at least 180 days of continuous health plan enrollment before and including the treatment initiation date
排除标准
- •Patients with Type 1 diabetes mellitus
- •Patients with missing age or sex information
- •Patients with history of proliferative diabetic retinopathy, panretinal photocoagulation, vitreous hemorrhage, or intravitreal anti-VEGF injection
- •Patient within history of left ventricular assisted device (LVAD) or heart transplant
- •Patients with any previous organ transplants
- •Patients with acute of chronic pancreatitis
- •Patients with gastroparesis, bowel obstruction or bariatric surgery
- •Patient with CKD Stage 5, end stage kidney disease, kidney transplant, or hemodialysis
- •Patients with multiple endocrine neoplasm syndrome type 2 (MEN-2)
- •Patient with cancer
- •Pregnant women
- •Patient with diabetic ketoacidosis or HONK within the last year to treatment initiation
- •Patients with acute hepatitis within the last year to treatment initiation
- •Patients with elevated serum calcitonin level within the last year to treatment initiation
- •Previous exposure to GLP-1RA or pramlintide during the 180-days washout period and including treatment initiation date
- •Patients with severe hypoglycemia within the last 6 months to treatment initiation
- •Patients with hospitalization for heart failure within the last 60 days to treatment initiation
- •Patient with acute coronary syndrome, ischemic stroke, peripheral arterial disease, or coronary or cerebrovascular procedure within the last 60 days to treatment initiation
- •Patients with prescription dispensing for both tirzepatide and dulaglutide on treatment initiation date
研究组 & 干预措施
Tirzepatide
Patients who initiated tirzepatide with no use in the prior 180 days
干预措施: Tirzepatide (Drug)
Dulaglutide
Patients who initiate dulaglutide with no use in the prior 180 days
干预措施: Dulaglutide (Drug)
Semaglutide
Patients who initiate semaglutide with no use in the prior 180 days
干预措施: Semaglutide (Drug)
结局指标
主要结局
Composite CV outcome
时间窗: From treatment initiation to end of follow up, up to 48 months.
Composite CV outcome includes myocardial infarction, stroke, and all-cause mortality.
次要结局
未报告次要终点
研究者
Elisabetta Patorno
MD, DrPH
Brigham and Women's Hospital