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Table 1 Key inclusion criteria

From: Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

Insufficient glycemic control High risk of cardiovascular events (≥1 of the following)
Drug-naive subjects: HbA1c ≥7.0% and ≤9.0% at screening • History of myocardial infarction >2 months prior to informed consent
• Evidence of multi-vessel CAD i.e. in ≥ 2 major coronary arteries or the left main coronary artery, documented by any of the following:
Subjects on background therapy: HbA1c ≥7.0% and ≤10.0% at screening – 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 peripheral artery disease 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
  1. CAD, coronary artery disease.