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Table 2 Inclusion criteria of patients enrolled in CVOTs referred to in the text

From: Updates on cardiovascular outcome trials in diabetes

 

Age

Diabetes type

HbA1c levels

Cardiovascular status

Prior anti hyperglycaemic treatment

BMI (Kg/m2)

SAVOR-TIMI53

≥ 40

T2DM

≥ 6.5%

CVD or high CV risk

AHA

31.1

EXAMINE

≥ 18

T2DM

(6.5, 11.0%)

ACS (15, 90) days before

AHA

28.7

TECOS

≥ 50

T2DM

(6.5, 8.0%)

pre-existing CVD

AHA

30.2

ELIXA

≥ 30

T2DM

≥ 7.0%

ACS min. 180 days before

AHA

30.2

EMPA-REG OUTCOME

≥ 18

T2DM

(7.0, 10.0%)

Pre-existing CVD

Drug naive or AHA

≤ 45

LEADER

≥ 50

T2DM

≥ 7.0%

Pre-existing CVD/cerebrovascular disease/vascular disease/renal or heart failure at ≥ 50 or CV risk at ≥ 60

Drug naive or AHA

32.5

SUSTAIN6

≥ 50

T2DM

≥ 7.0%

Pre-existing CVD at ≥ 50 OR pre-CVD at ≥ 60

Drug naive or AHA

31.1

EXSCEL

≥ 18

T2DM

6.5–10.0%

73.1% with previous CVD

Specific AHA

CAROLINA

≥ 40 ≤ 85

T2DM

(6.5, 7.5–8.5%)

CVD or specified diabetes end-organ damage or age ≥ 70 years or ≥ 2 specified CV risk factors

≤ 45

REWIND

≥ 50

T2DM

≤ 9.5%

Pre-existing vascular disease or ≥ CV risk factors

AHA

ITCA650

≥ 40

T2DM

≥ 6.5%

Pre-existing coronary, cerebrovascular or peripheral artery disease

DECLARE-TIMI

≥ 40

T2DM

High risk CV events

CARMELINA

≥ 18

T2DM

(6.5, 10.0%)

High risk CV events

Drug naive or specific AHA

≤ 45

DEVOTE

≥ 50

T2DM

≤ 7.0%

CVD or renal disease or ≥ 60 CV risk

Specific AHA

MK-3102

≥ 40

T2DM

(6.5, 10.0%)

Pre-existing vascular disease

VERTIS

≥ 40

T2DM

(7.0, 10.5%)

Pre-existing vascular disease

Drug naive or AHA

≥ 18

CANVAS program

≥ 40

T2DM

(7.0, 10.5%)

Pre-existing CVD or high CV risk

Drug naive or AHA

Albiglutide trial

≥ 40

T2DM

> 7.0%

CVD

ACE

≥ 65

Prediabetes

5.9%

CV event within the last 3 month

Drug naive

25