. 2023 Jun 28;22:153. doi: 10.1186/s12933-023-01877-6

Table 1.

Baseline Characteristics of Cardiovascular Outcome Trials with SGLT-2is or GLP-1RAs in Patients with Type 2 Diabetes

Trial	Mean Follow-up	N	Participants’ characteristics	Characteristics of diabetes	Characteristics of comorbidities	Concurrent medication	Risk of events*
CANVAS program [25] (Canagliflozin)	3.6 yr	10,142	Age: 63.3 yr Men: 64.2%	BMI: 32 kg/m² SBP: 136.6 mmHg LDLc: 2.3 mmol/L	HbA1c: 8.2% DM duration: 13.5 yr	HTN: 90.0% CVD: 65.6% HF: 14.4%	eGFR < 60: 20.1% ACR ≥ 30 mg/g: 29.8%	Statin 74.9% Antithrombotics 73.6% RAAS blockers 80.0%	3P-MACE 2.7/3.2 (100PY)
CREDENCE [35] (Canagliflozin)	2.6 yr	4,401	Age: 63 yr Men: 66.1%	BMI: 31.3 kg/m² SBP: 140.0 mmHg LDLc: 2.5 mmol/L	HbA1c: 8.3% DM duration: 15.8 yr	HTN: 96.8% CVD: 50.4% HF: 14.8%	eGFR < 60: 59.8% ACR ≥ 30 mg/g: 99.3%	Statin 69.0% Antithrombotics 59.6% RAAS blockers 99.9%	3P-MACE 3.9/4.9 (100PY)
DECLARE-TIMI 58 [36] (Dapagliflozin)	4.2 yr†	17,160	Age: 63.9 yr Men: 62.6%	BMI: 32.1 kg/m² SBP: 135.8 mmHg LDLc: 2.3 mmol/L	HbA1c: 8.3% DM duration: 11.8 yr	HTN‡: 89.4% CVD: 40.6% HF: 10.0%	eGFR < 60: 7.4% ACR ≥ 30 mg/g: 30.3%	Statin 75.0% Antithrombotics 61.1% RAAS blockers 81.3%	3P-MACE 2.3/2.4 (100PY)
EMPA-REG OUTCOME [11] (Empagliflozin)	3.0 yr	7,020	Age: 63.1 yr Men: 71.5%	BMI: 30.6 kg/m² SBP: 135.5 mmHg LDLc: 2.2 mmol/L	HbA1c: 8.1% DM duration > 10 year: 57.1%	HTN‡: 94.6% CVD: 100% HF: 10.1%	eGFR < 60: 25.9% ACR ≥ 30 mg/g: 39.6%	Statin 77.0% Antithrombotics 89.1% RAAS blockers 80.7%	3P-MACE 3.7/4.4 (100PY)
VERTIS-CV [37] (Ertugliflozin)	3.5 yr	8,246	Age: 64.4 yr Men: 70.0%	BMI: 29.5 kg/m² SBP: 133.4 mmHg LDLc: 2.3 mmol/L	HbA1c: 8.2% DM duration: 13.0 yr	HTN‡: 95.2% CVD: 100% HF: 23.7%	eGFR < 60: 21.9% ACR ≥ 30 mg/g: 39.3%	Statin 82.3% Antithrombotics 88.9% RAAS blockers 81.1%	3P-MACE 3.9/4.0 (100PY)
SCORED [8] (Sotagliflozin)	1.3 yr†	10,584	Age: 69 yr Men: 55.1%	BMI: 31.8 kg/m² SBP: 138.5 mmHg	HbA1c: 8.3%	CVD: 48.6% HF: 31.0%	eGFR < 60: 100% ACR ≥ 30 mg/g: 65.0%	RAAS blockers 88.5%	3P-MACE 4.1/4.7 (100PY)
EXSCEL [28] (Exenatide)	3.3 yr†	14,752	Age: 62 yr Men: 62.0%	BMI: 32.7 kg/m² SBP: 135.5 mmHg LDLc: 2.3 mmol/L	HbA1c: 8.1% DM duration: 13.1 yr	HTN‡: 90.3% CVD: 73.1% HF: 16.2%	eGFR < 60: 21.6% ACR ≥ 30 mg/g: 15.9%	Statin 73.5% Antithrombotics 73.4% RAAS blockers 85.0%	3P-MACE 3.7/4.0 (100PY)
LEADER [21] (Liraglutide)	3.8 yr†	9,340	Age: 64.3 yr Men: 64.3%	BMI: 32.5 kg/m² SBP: 135.9 mmHg LDLc: 2.3 mmol/L	HbA1c: 8.7% DM duration: 12.7 yr	HTN: 90.0% CVD: 81.3% HF: 17.8%	eGFR < 60: 23.1% ACR ≥ 30 mg/g: 36.6%	Statin 72.2% Aspirin 69.8% RAAS blockers 77.2%	3P-MACE 3.4/3.9 (100PY)
REWIND [13] (Dulaglutide)	5.5 yr†	9,901	Age: 66.2 yr Men: 53.7%	BMI: 32.3 kg/m² SBP: 137.2 mmHg LDLc: 2.6 mmol/L	HbA1c: 7.3% DM duration: 10.5 yr	HTN: 93.2% CVD: 31.5% HF: 8.6%	eGFR < 60: 22.2% ACR ≥ 30 mg/g: 35.0%	Statin 66.1% Antithrombotics 54.0% RAAS blockers 81.5%	3P-MACE 2.4/2.7 (100PY)
Harmony [19] (Albiglutide)	1.6 yr†	9,463	Age: 64.2 yr Men: 69.4%	BMI: 32.3 kg/m² SBP: 134.7 mmHg LDLc: 2.1 mmol/L	HbA1c: 8.7% DM duration: 14.2 yr	HTN: 86.5% CVD: 100% HF: 20.3%	eGFR < 60: 23.5%	Statin 84.0% Antithrombotics 84.1% RAAS blockers 81.6%	3P-MACE 4.6/5.9 (100PY)
SUSTAIN-6 [29] (Semaglutide)	2.1 yr	3,297	Age: 64.6 yr Men: 60.7%	BMI: 32.8 kg/m² SBP: 135.6 mmHg LDLc: 2.1 mmol/L	HbA1c: 8.7% DM duration: 13.9 yr	HTN: 92.8% CVD: 83.0% HF: 23.6%	eGFR < 60: 28.5% ACR ≥ 30 mg/g: 42.0%	Statin 72.8% Antithrombotics 76.3% RAAS blockers 83.5%	3P-MACE 3.2/4.4 (100PY)
PIONEER 6 [20] (Oral semaglutide)	1.0 yr†	3,183	Age: 66 yr Men: 68.4%	BMI: 32.3 kg/m² SBP: 135.6 mmHg LDLc: 2.2 mmol/L	HbA1c: 8.2% DM duration: 14.9 yr	HTN‡: 95.3% CVD: 84.7% HF: 12.2%	eGFR < 60: 26.9%	Lipid-lowering agents 85.2% Antithrombotics 79.4%	3P-MACE 2.6/3.7 (100PY)
AMPLITUDE-O [18] (Efpeglenatide)	1.8 yr†	4,076	Age: 64.5 yr Men: 67.0%	BMI: 32.7 kg/m² SBP: 134.9 mmHg LDLc: 2.1 mmol/L	HbA1c: 8.9% DM duration: 15.4 yr	HTN: 91.3% CVD: 89.5% HF: 18.1%	eGFR < 60: 31.6% ACR ≥ 30 mg/g: 48.5%	Statin 80.8% Aspirin 67.9% Other antiplatelets 25.7% RAAS blockers 80.0%	3P-MACE 5.4/6.8 (100PY)

Trial

Mean Follow-up

Participants’ characteristics

Characteristics of diabetes

Characteristics of comorbidities

Concurrent medication

Risk of events*

CANVAS program [25]

(Canagliflozin)

3.6 yr

10,142

Age: 63.3 yr

Men: 64.2%

BMI: 32 kg/m²

SBP: 136.6 mmHg

LDLc: 2.3 mmol/L

HbA1c: 8.2%

DM duration: 13.5 yr

HTN: 90.0%

CVD: 65.6%

HF: 14.4%

eGFR < 60: 20.1%

ACR ≥ 30 mg/g: 29.8%

Statin 74.9%

Antithrombotics 73.6%

RAAS blockers 80.0%

3P-MACE

2.7/3.2 (100PY)

CREDENCE [35]

(Canagliflozin)

2.6 yr

4,401

Age: 63 yr

Men: 66.1%

BMI: 31.3 kg/m²

SBP: 140.0 mmHg

LDLc: 2.5 mmol/L

HbA1c: 8.3%

DM duration: 15.8 yr

HTN: 96.8%

CVD: 50.4%

HF: 14.8%

eGFR < 60: 59.8%

ACR ≥ 30 mg/g: 99.3%

Statin 69.0%

Antithrombotics 59.6%

RAAS blockers 99.9%

3P-MACE

3.9/4.9 (100PY)

DECLARE-TIMI 58 [36]

(Dapagliflozin)

4.2 yr†

17,160

Age: 63.9 yr

Men: 62.6%

BMI: 32.1 kg/m²

SBP: 135.8 mmHg

LDLc: 2.3 mmol/L

HbA1c: 8.3%

DM duration: 11.8 yr

HTN‡: 89.4%

CVD: 40.6%

HF: 10.0%

eGFR < 60: 7.4%

ACR ≥ 30 mg/g: 30.3%

Statin 75.0%

Antithrombotics 61.1%

RAAS blockers 81.3%

3P-MACE

2.3/2.4 (100PY)

EMPA-REG OUTCOME [11]

(Empagliflozin)

3.0 yr

7,020

Age: 63.1 yr

Men: 71.5%

BMI: 30.6 kg/m²

SBP: 135.5 mmHg

LDLc: 2.2 mmol/L

HbA1c: 8.1%

DM duration > 10 year: 57.1%

HTN‡: 94.6%

CVD: 100%

HF: 10.1%

eGFR < 60: 25.9%

ACR ≥ 30 mg/g: 39.6%

Statin 77.0%

Antithrombotics 89.1%

RAAS blockers 80.7%

3P-MACE

3.7/4.4 (100PY)

VERTIS-CV [37]

(Ertugliflozin)

3.5 yr

8,246

Age: 64.4 yr

Men: 70.0%

BMI: 29.5 kg/m²

SBP: 133.4 mmHg

LDLc: 2.3 mmol/L

HbA1c: 8.2%

DM duration: 13.0 yr

HTN‡: 95.2%

CVD: 100%

HF: 23.7%

eGFR < 60: 21.9%

ACR ≥ 30 mg/g: 39.3%

Statin 82.3%

Antithrombotics 88.9%

RAAS blockers 81.1%

3P-MACE

3.9/4.0 (100PY)

SCORED [8]

(Sotagliflozin)

1.3 yr†

10,584

Age: 69 yr

Men: 55.1%

BMI: 31.8 kg/m²

SBP: 138.5 mmHg

HbA1c: 8.3%

CVD: 48.6%

HF: 31.0%

eGFR < 60: 100%

ACR ≥ 30 mg/g: 65.0%

RAAS blockers 88.5%

3P-MACE

4.1/4.7 (100PY)

EXSCEL [28]

(Exenatide)

3.3 yr†

14,752

Age: 62 yr

Men: 62.0%

BMI: 32.7 kg/m²

SBP: 135.5 mmHg

LDLc: 2.3 mmol/L

HbA1c: 8.1%

DM duration: 13.1 yr

HTN‡: 90.3%

CVD: 73.1%

HF: 16.2%

eGFR < 60: 21.6%

ACR ≥ 30 mg/g: 15.9%

Statin 73.5%

Antithrombotics 73.4%

RAAS blockers 85.0%

3P-MACE

3.7/4.0 (100PY)

LEADER [21]

(Liraglutide)

3.8 yr†

9,340

Age: 64.3 yr

Men: 64.3%

BMI: 32.5 kg/m²

SBP: 135.9 mmHg

LDLc: 2.3 mmol/L

HbA1c: 8.7%

DM duration: 12.7 yr

HTN: 90.0%

CVD: 81.3%

HF: 17.8%

eGFR < 60: 23.1%

ACR ≥ 30 mg/g: 36.6%

Statin 72.2%

Aspirin 69.8%

RAAS blockers 77.2%

3P-MACE

3.4/3.9 (100PY)

REWIND [13]

(Dulaglutide)

5.5 yr†

9,901

Age: 66.2 yr

Men: 53.7%

BMI: 32.3 kg/m²

SBP: 137.2 mmHg

LDLc: 2.6 mmol/L

HbA1c: 7.3%

DM duration: 10.5 yr

HTN: 93.2%

CVD: 31.5%

HF: 8.6%

eGFR < 60: 22.2%

ACR ≥ 30 mg/g: 35.0%

Statin 66.1%

Antithrombotics 54.0%

RAAS blockers 81.5%

3P-MACE

2.4/2.7 (100PY)

Harmony [19]

(Albiglutide)

1.6 yr†

9,463

Age: 64.2 yr

Men: 69.4%

BMI: 32.3 kg/m²

SBP: 134.7 mmHg

LDLc: 2.1 mmol/L

HbA1c: 8.7%

DM duration: 14.2 yr

HTN: 86.5%

CVD: 100%

HF: 20.3%

eGFR < 60: 23.5%

Statin 84.0%

Antithrombotics 84.1%

RAAS blockers 81.6%

3P-MACE

4.6/5.9 (100PY)

SUSTAIN-6 [29]

(Semaglutide)

2.1 yr

3,297

Age: 64.6 yr

Men: 60.7%

BMI: 32.8 kg/m²

SBP: 135.6 mmHg

LDLc: 2.1 mmol/L

HbA1c: 8.7%

DM duration: 13.9 yr

HTN: 92.8%

CVD: 83.0%

HF: 23.6%

eGFR < 60: 28.5%

ACR ≥ 30 mg/g: 42.0%

Statin 72.8%

Antithrombotics 76.3%

RAAS blockers 83.5%

3P-MACE

3.2/4.4 (100PY)

PIONEER 6 [20]

(Oral semaglutide)

1.0 yr†

3,183

Age: 66 yr

Men: 68.4%

BMI: 32.3 kg/m²

SBP: 135.6 mmHg

LDLc: 2.2 mmol/L

HbA1c: 8.2%

DM duration: 14.9 yr

HTN‡: 95.3%

CVD: 84.7%

HF: 12.2%

eGFR < 60: 26.9%

Lipid-lowering agents 85.2%

Antithrombotics 79.4%

3P-MACE

2.6/3.7 (100PY)

AMPLITUDE-O [18]

(Efpeglenatide)

1.8 yr†

4,076

Age: 64.5 yr

Men: 67.0%

BMI: 32.7 kg/m²

SBP: 134.9 mmHg

LDLc: 2.1 mmol/L

HbA1c: 8.9%

DM duration: 15.4 yr

HTN: 91.3%

CVD: 89.5%

HF: 18.1%

eGFR < 60: 31.6%

ACR ≥ 30 mg/g: 48.5%

Statin 80.8%

Aspirin 67.9%

Other antiplatelets 25.7%

RAAS blockers 80.0%

3P-MACE

5.4/6.8 (100PY)

BMI, body mass index; SBP, systolic blood pressure; LDLc, low-density lipoprotein cholesterol; HTN, hypertension; CVD, cardiovascular disease; HF, heart failure; eGFR, estimated glomerular filtration rate; ACR, albumin–creatinine ratio; RAAS, renin–angiotensin–aldosterone system; 3P-MACE, 3-point major adverse cardiovascular events; 100PY, 100 patient-year. * 3P-MACE event rate (100 patients-year) of active/placebo group. † Median and interquartile range converted to the mean value. ‡ Medically treated hypertension