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. 2021 Jan 28;10:100082. doi: 10.1016/j.metop.2021.100082

Table 2.

Cardiovascular risk characteristics in primary prevention T2DM groups in SGLT2i CVOT.

CVOT/SGLT2i Population characteristics in primary prevention group %/n of patients in primary prevention group
DECLARE-TIMI 58 [32]/Dapagliflozin Adults with T2DM (HbA1c ≥6.5%) and no known CVD and ≥2 CV risk factors in addition to T2DM, defined as:
  • Age ≥55 years (men) or ≥60 (women)

  • Not history of revascularization procedure

  • Presence of ≥1 of the following additional risk factors:
    • Dyslipidemia, defined as either LDL-C >130 mg/dL (3.36 mmol/L) within last 12 months or on lipid-lowering therapy for hypercholesterolemia (LDL-C >130 mg/dL (3.36 mmol/L) for >12 months
    • Hypertension, defined as either elevated SBP/DBP (>140/90 mmHg) at enrollment visit (based on the Cockroft-Gault equation) or on antihypertensive therapy for the elevated BP
Current tobacco use (≥5 cigarettes/day for at least 1 year at randomization)
59.4%, 10186
CANVAS program [30]/Canagliflozin Adults with T2DM (HbA1c: ≥7.0% to ≤10.5%) and the following risk factors:
  • Age ≥50 years

  • T2DM duration of ≥10 years

  • Current daily cigarette smoker

  • SBP >140 mmHg, while the patient is on ≥1 antihypertensive treatment

  • No history of ASCVD or related procedures

  • eGFR ≥45 mL/min/1.73m2

  • Documented microalbuminuria/macroalbuminuria, or documented HDL-C of <1 mmol/L (<39 mg/dL)

34%, 3486
CREDENCE [31]/Canagliflozina Adults aged ≥30 years with T2DM (HbA1c ≥6.5% to ≤12.0%) and the following:
  • eGFR ≥30 to <90 mL/min/1.73 m2 (determined using the CKD-EPI)

  • UACR >300 mg/g to ≤5000 mg/g (>33.9 mg/mmol to ≤565.6 mg/mmol)

  • Controlled hypertension: SBP <180 mmHg and/or DBP <100 mmHg)

  • No ASCVD or related procedures

49.6%, 2181

ASCVD: atherosclerotic cardiovascular disease, CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration equation, CV: cardiovascular, CVD: cardiovascular disease, CVOT: cardiovascular outcome trials, DBP: diastolic blood pressure, eGFR: estimated glomerular filtration rate, HbA1c: glycated hemoglobin, HDL-C: high-density lipoprotein cholesterol, LDL-C: low density lipoprotein-cholesterol, SBP: systolic blood pressure, SGLT2i: sodium-glucose co-transporter 2 inhibitor, T2DM: type 2 diabetes mellitus, UACR: urinary albumin:creatinine ratio.

a

In CREDENCE trial, the inclusion criteria for patients with CVD and patients at CV risk were not separately listed.