Table 1

Variables and criteria used to assess eligibility of patients in the DISCOVER study for inclusion in CANVAS, DECLARE-TIMI 58, EMPA-REG OUTCOME, and VERTIS-CV

CriterionCANVASDECLARE-TIMI 58EMPA-REG OUTCOMEVERTIS-CV
All patients
HbA1c, %7.0–10.56.5–12.07.0–10.07.0–10.5
CKD historyPatients were excluded if:
  • eGFR was reported and <30 mL/min/1.73 m2.

  • Or if CKD was marked as present by the investigator.

Patients were excluded if:
  • eGFR was reported and <60 mL/min/1.73 m2.

  • Or if CKD was marked as present by the investigator.

Patients were excluded if:
  • eGFR was reported and <30 mL/min/1.73 m2.

  • Or if CKD was marked as present by the investigator.

No exclusion criterion.
BMI, kg/m2No criterion≥18.0
Patients with CV risk factors but no established CVD
Age, years≥50>55 (men), >60 (women)NA.*NA.*
CV risk factorsAt least two of the following risk factors:
  • Dyslipidemia.

    • LDL-C ≥154 mg/dL.

    • Or HDL-C ≤39 mg/dL.

    • Or use of lipid-lowering therapy.

    • Or hyperlipidemia marked as present by investigator.

  • Duration of diabetes ≥10 years.

  • Current smoker.

At least one of the following risk factors:
  • Dyslipidemia.

    • LDL-C >130 mg/dL.

    • Or use of lipid-lowering therapy.

    • Or hyperlipidemia marked as present by the investigator.

  • Hypertension

    • SBP >140 mm Hg.

    • Or DBP >90 mm Hg.

    • Or use of BP-lowering therapy.

    • Or hypertension marked as present by the investigator.

  • Current smoker.

NA.*NA.*
Patients with established CVD
Age, years≥30≥40≥18≥40
CV historyHistory of at least one of the following:
  • Angina

  • CABG.

  • CAD.

  • Ischemic stroke.

  • HF.

  • MI.

  • PCI.

History of at least one of the following:
  • CABG

  • CAD.

  • Carotid stenting.

  • Endarterectomy.

  • Ischemic stroke.

  • Lower extremity amputation.

  • MI.

  • PAD.

  • PCI.

History of at least one of the following:
  • Angina.

  • CABG.

  • CAD.

  • Ischemic or hemorrhagic stroke.

  • Lower extremity amputation.

  • MI.

  • PAD.

  • PCI.

History of at least one of the following:
  • Angina.

  • CABG.

  • CAD.

  • Ischemic stroke.

  • MI.

  • PAD.

  • PCI.

  • *No patients without established CVD in EMPA-REG OUTCOME and VERTIS-CV.

  • BMI, body mass index;BP, blood pressure;CABG, coronary artery bypass graft;CAD, coronary artery disease;CKD, chronic kidney disease;CV, cardiovascular;CVD, cardiovascular disease;DBP, diastolic blood pressure;eGFR, estimated glomerular filtration rate;HbA1c, glycated hemoglobin;HDL-C, high-density lipoprotein cholesterol;HF, heart failure;LDL-C, low-density lipoprotein cholesterol;MI, myocardial infarction;NA, not applicable;PAD, peripheral artery disease;PCI, percutaneous coronary intervention;SBP, systolic blood pressure.