EMPA-REG OUTCOME Trial: as published in <br><em>The New England Journal of Medicine</em><sup>1</sup>
EMPA-REG OUTCOME Trial: as published in
The New England Journal of Medicine1
PATIENTS STUDIED HAD:
Evidenced by coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke
TYPE 2 DIABETES
A1C baseline of ≥7%-≤10%
Patients were randomized to receive:
JARDIANCE 10 mg
JARDIANCE 25 mg
These patients were receiving cardiovascular and type 2
diabetes standard of care medications*
TYPE 2 DIABETES MEDICATIONS
Investigators were encouraged to manage CV risk factors and blood glucose by actively adjusting all medications in order to achieve appropriate treatment goals in all treatment groups.
JARDIANCE CV Outcome Trial Design: A randomized, double-blind, parallel-group trial comparing the risk of experiencing a major adverse cardiovascular event between JARDIANCE and placebo when these were added to and used concomitantly with standard of care treatments for type 2 diabetes and cardiovascular disease. A total of 7020 patients were treated (JARDIANCE 10 mg [N=2345]; JARDIANCE 25 mg [N=2342]; placebo [N=2333]) and followed for a median of 3.1 years. All patients had established atherosclerotic cardiovascular disease at baseline, including one or more of the following: a documented history of coronary artery disease, peripheral artery disease, myocardial infarction, or stroke. The primary outcome was reduction in risk of cardiovascular events, defined by the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
ESTABLISHED CV DISEASE DEFINITIONS1
- History of myocardial infarction >2 months prior to informed consent
- Evidence of multi-vessel CAD, ie in ≥2 major coronary arteries or the left main coronary artery, documented by any of the following:
- - Presence of significant stenosis: ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography)
- - Previous revascularization (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent)
- - The combination of revascularization in one major coronary artery and significant stenosis (≥50% luminal narrowing) in another major coronary artery
- Evidence of single-vessel CAD, ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography) not subsequently successfully revascularized, with at least 1 of the following:
- - A positive non-invasive stress test for ischemia
- - Hospital discharge for unstable angina ≤12 months prior to consent
- Unstable angina >2 months prior to consent with evidence of single- or multi-vessel CAD
- History of stroke (ischemic or hemorrhagic) >2 months prior to consent
- Occlusive PAD documented by any of the following:
- - Limb angioplasty, stenting, or bypass surgery
- - Limb or foot amputation due to circulatory insufficiency
- - Evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via non-invasive methods) in 1 limb
- - Ankle brachial index <0.9 in ≥1 ankle
CAD=coronary artery disease; PAD=peripheral artery disease.
*Percentages reflect medications taken at baseline. Type 2 diabetes medications were kept stable for the first 12 weeks.
ACEIs=angiotensin-converting enzyme inhibitors; ARBs=angiotensin II receptor blockers; CV=cardiovascular.
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