Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,118
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality or heart failure hospitalization
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 semaglutide after emulating the pivotal RCTs of each drug used to support regulatory approval in heart failure with preserved ejection fraction (SUMMIT and STEP-HFpEF DM trials).This comparative effectiveness target trial described below draws from eligibility criteria from the SUMMIT and STEP-HFpEF DM trials. Although many features of the target trial 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 database study will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs semaglutide on the composite end point of all-cause mortality or heart failure hospitalization. Clinical guidelines during the study period recommended both agents for the same indications of glucose lowering and weight reduction. Indication for heart failure with preserved ejection fraction has not been granted for both drugs during the study period.
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
- •Eligible cohort entry dates:
- •Optum: Study period between May 13, 2022 to November 30,
- •Marketscan: Study period between May 13, 2022 to December 31,
- •Inclusion Criteria:
- •Heart failure
- •BMI > 27.0 kg/m2
- •History of type 2 diabetes mellitus
- •LVEF ≥ 45%
- •≥ 18 years old, male or female sex
排除标准
- •Prior treatment with any GLP-1-RA
- •History of type 1 diabetes mellitus
- •End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
- •History of bariatric surgery
- •History of nursing home admission
- •Pregnant female or breastfeeding
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
- •Treatment with continuous subcutaneous insulin infusion
- •Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years
研究组 & 干预措施
Tirzepatide
New use of tirzepatide dispensing claim is used as the exposure.
干预措施: Tirzepatide (Drug)
Semaglutide
New use of semaglutide dispensing claim is used as the reference.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Composite of all-cause mortality or heart failure hospitalization
时间窗: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
To evaluate the comparative effect of tirzepatide vs semaglutide on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction.
次要结局
- Composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting).(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting).(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Intravenous diuretic therapy in an urgent care setting(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Hospitalization for heart failure(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- All-cause mortality(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Urinary tract infection(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Serious bacterial infection(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Gastrointestinal adverse events(Through study completion (1 day after cohort entry date until the first of outcome or censoring))
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital