EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program
概览
- 阶段
- 不适用
- 干预措施
- Empagliflozin
- 疾病 / 适应症
- Diabetes Mellitus, Type 2
- 发起方
- Boehringer Ingelheim
- 入组人数
- 230000
- 试验地点
- 1
- 主要终点
- 3-point major adverse cardiovascular events (MACE)
- 状态
- 进行中（未招募）
- 最后更新
- 11天前
概览
简要总结
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality.
However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.
研究者
入排标准
入选标准
- •Patients \>= 18 years old for Marketscan and Optum, and \>=65 years old for Medicare only
- •Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
- •Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.
排除标准
- •Patients with missing or ambiguous age or sex information.
- •All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
- •Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
- •Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
- •History of cancer in the 5 years prior to drug initiation
- •End-stage renal disease (ESRD) in the 12 months prior to drug initiation
- •HIV diagnosis or treatment in the 12 months prior to drug initiation
- •Organ transplant in the 12 months prior to drug initiation
- •Patients that were in nursing homes in the 12 months prior to drug initiation
- •Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
研究组 & 干预措施
patients with T2DM initiating empagliflozin
Type 2 diabetes mellitus
干预措施: Empagliflozin
patients with T2DM initiating a DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor treated patients
干预措施: DPP-4 inhibitor
patients with T2DM initiating a GLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonist treated patients
干预措施: GLP-1 receptor agonist
结局指标
主要结局
3-point major adverse cardiovascular events (MACE)
时间窗: 60 months
i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component: * Hospital admission for MI (for purposes of this individual component, fatal MI is included) * Hospital admission for stroke (for purposes of this individual component, fatal stroke is included) * CV mortality
Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)
时间窗: 60 months
Hospitalization for heart failure (broad, based on any inpatient diagnosis code)
时间窗: 60 months
Modified MACE
时间窗: 60 months
i.e., composite of MI, stroke or all-cause mortality
Composite of MI or stroke hospital admission for heart failure
时间窗: 60 months
All-cause mortality
时间窗: 60 months
次要结局
- Diabetic ketoacidosis (Inpatient, primary position)(60 months)
- Diabetic ketoacidosis (Inpatient, any position)(60 months)
- Severe hypoglycemia(60 months)
- Coronary revascularization procedure(60 months)
- Hospitalization for unstable angina(60 months)
- Composite of MI, stroke, unstable angina hospitalization or coronary revascularization(60 months)
- End-stage renal disease (ESRD)(60 months)
- Bone fracture(60 months)
- Urinary tract cancers(60 months)
- Lower-limb amputation(60 months)
- Acute kidney injury (Inpatient, primary)(60 months)
- Acute kidney injury (Inpatient, any position)(60 months)