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Table 1 Baseline differences between Europe and US patients, stratified by history of prior CVD

From: LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

 

No prior CVD group (n = 1013)

Prior CVD group (n = 4996)

Europe (n = 599)

USA (n = 414)

P value

Europe (n = 2922)

USA (n = 2074)

P value

Gender, female (n,  %)

223 (37.2)

177 (42.8)

0.077

857 (29.3)

710 (34.2)

0.001

Age, years (mean, SD) (n,  %)

66.0 (5.0)

66.1 (5.6)

0.783

64.6 (7.5)

64.3 (7.7)

0.166

 50–59

10 (1.7)

8 (1.9)

 

798 (27.3)

589 (28.4)

 

 60–69

454 (75.8)

310 (74.9)

 

1364 (46.7)

971 (46.8)

 

 70–79

127 (21.2)

84 (20.3)

0.355

694 (23.8)

451 (21.7)

0.240

 80–89

8 (1.3)

12 (2.9)

 

65 (2.2)

62 (3.0)

 

 90–99

0 (0)

0 (0)

 

1 (0.0)

1 (0.0)

 

Diabetes duration, years (mean, SD)

11.2 (6.8)

13.2 (7.9)

<0.001

11.7 (7.6)

13.5 (8.8)

<0.001

Race (n,  %)

 

 Asian

3 (0.5)

9 (2.2)

 

25 (0.9)

37 (1.8)

 

 Black

2 (0.3)

101 (24.4)

<0.001

14 (0.5)

366 (17.6)

<0.001

 White

592 (98.8)

295 (71.3)

 

2871 (98.3)

1622 (78.2)

 

 Other

2 (0.3)

9 (2.2)

 

12 (0.4)

49 (2.4)

 

Body weight, kg (mean, SD)

94.0 (18.1)

98.9 (23.4)

<0.001

93.6 (18.6)

101.1 (21.8)

<0.001

BMI, kg/m2 (mean, SD) (n,  %)

33.0 (5.6)

34.4 (6.9)

<0.001

32.7 (5.8)

34.6 (6.8)

<0.001

 18–25

25 (4.2)

24 (5.8)

 

181 (6.2)

96 (4.6)

 

 25–30

176 (29.4)

91 (22.0)

 

843 (28.9)

438 (21.1)

 

 30–35

216 (36.1)

125 (30.2)

<0.001

1024 (35.0)

686 (33.1)

<0.001

 35–40

113 (18.9)

91 (22.0)

 

554 (19.0)

478 (23.0)

 

 >40

69 (11.5)

83 (20.0)

 

316 (10.8)

375 (18.1)

 

Waist circumference, cm (mean, SD)

112.2 (15.5)

114.1 (18.4)

0.072

111.2 (15.3)

114.5 (17.0)

<0.001

HbA1c,  % (mean, SD)

8.4 (1.3)

8.9 (1.6)

<0.001

8.3 (1.3)

8.8 (1.5)

<0.001

HbA1c at target (n,  %)

 

 ≤7.5 %

186 (31.1)

68 (16.4)

<0.001

880 (30.1)

481 (23.2)

<0.001

 ≤7 %

49 (8.2)

18 (4.3)

0.016

264 (9.0)

157 (7.6)

0.066

SBP, mmHg (mean, SD)

144.1 (17.5)

135.5 (17.1)

<0.001

140.0 (18.4)

133.3 (18.5)

<0.001

DBP, mmHg (mean, SD)

81.0 (9.7)

76.0 (9.5)

<0.001

78.5 (10.2)

74.7 (10.5)

<0.001

BP at target (n,  %) (Europe < 140/80 and USA 130/80 mmHg)

146 (24.4)

134 (32.4)

0.005

974 (33.3)

800 (38.6)

<0.001

LDL, mmol/L (mean, SD)

2.5 (0.9)

2.3 (0.9)

<0.001

2.3 (0.9)

2.2 (0.9)

0.113

At target (n,  %)

319 (53.3)

273 (65.9)

<0.001

1934 (66.2)

757 (36.5)

<0.001

HDL, mmol/L (mean, SD)

1.3 (0.3)

1.2 (0.4)

0.104

1.2 (0.3)

1.2 (0.3)

0.008

Triglyceride, mmol/L (mean, SD)

2.0 (1.3)

2.0 (2.0)

0.749

2.1 (1.8)

2.0 (1.5)

0.038

Creatinine, μmol/L (mean, SD)

71.6 (14.6)

73.1 (15.6)

0.106

85.4 (31.2)

94.7 (38.2)

<0.001

ACR, mg/mmol (mean, SD)

10.6 (30.5)

14.8 (50.5)

0.135

16.4 (57.3)

26.5 (82.0)

<0.001

eGFR (mean, SD)

90.0 (24.0)

90.3 (20.5)

0.847

81.3 (26.8)

74.8 (27.1)

<0.001

Renal function, eGFR (mL/min/1.73 m2) (n,  %)

 

 Normal (≥ 90)

268 (44.7)

181 (43.7)

 

1079 (36.9)

591 (28.5)

 

 Mild decline (60–90)

331 (55.3)

233 (56.3)

0.748

1191 (40.8)

809 (39.0)

<0.001

 Moderate decline (30–60)

0 (0.0)

0 (0.0)

 

605 (20.7)

625 (30.1)

 

 Severe decline (< 30)

0 (0.0)

0 (0.0)

 

47 (1.6)

49 (2.4)

 

Micro-albuminuria (n,  %)

246 (41.1)

233 (56.3)

<0.001

347 (11.9)

248 (12.0)

0.930

Macro-albuminuria (n,  %)

31 (5.2)

65 (15.7)

<0.001

77 (2.6)

66 (3.2)

0.253

Myocardial infarction (n,  %)

0 (0)

0 (0)

 

567 (19.4)

321 (15.5)

<0.001

Stroke (n,  %)

0 (0)

0 (0)

 

434 (14.9)

289 (13.9)

0.363

Angina pectoris (n,  %)

0 (0)

5 (0.8)

0.062

1114 (38.1)

617 (29.7)

<0.001

Arrhythmia (n,  %)

57 (9.5)

45 (10.9)

0.482

479 (16.4)

394 (19.0)

0.017

Left ventricle dysfunction (n,  %)

188 (31.4)

56 (13.5)

<0.001

702 (24.0)

379 (18.3)

<0.001

Smoking (n,  %)

 Current

83 (13.9)

57 (13.8)

 

407 (13.9)

278 (13.4)

 

 Never

248 (41.4)

187 (45.2)

0.455

946 (32.4)

754 (36.4)

0.013

 Previous

268 (44.7)

170 (41.1)

 

1569 (53.7)

1042 (50.2)

 

Pre-trial treatment (n,  %)

 

 None/diet

16 (2.7)

41 (9.9)

 

102 (3.5)

226 (10.9)

 

 Insulin only

19 (3.2)

22 (5.3)

<0.001

200 (6.8)

210 (10.1)

<0.001

 OADs only

380 (63.4)

213 (51.4)

 

1624 (55.6)

973 (46.9)

 

 Insulin + OADs

184 (30.7)

138 (33.3)

 

996 (34.1)

665 (32.1)

 

Number of oral blood glucose-lowering drugs (n,  %)

 

 No OAD

219 (36.6)

201 (48.6)

 

1298 (44.4)

1101 (53.1)

 

 1 OAD

155 (25.9)

83 (20.0)

0.424

707 (24.2)

428 (20.6)

0.013

 2 OADs

199 (33.2)

109 (26.3)

 

826 (28.3)

463 (22.3)

 

 >2 OADs

26 (4.3)

21 (5.1)

 

91 (3.1)

82 (4.0)

 

BP-lowering medication (n,  %)

517 (86.3)

360 (87.0)

0.767

2729 (93.4)

1930 (93.1)

0.639

Number of antihypertensive medications (n,  %)

 

 0

82 (13.7)

54 (13.0)

 

193 (6.6)

144 (6.9)

 

 1

225 (37.6)

182 (44.0)

0.018

731 (25.0)

607 (29.3)

0.001

 2

172 (28.7)

126 (30.4)

 

1315 (45.0)

920 (44.4)

 

 3

93 (15.5)

44 (10.6)

 

533 (18.2)

324 (15.6)

 

 4

27 (4.5)

8 (1.9)

 

150 (5.1)

79 (3.8)

 

Statin (n,  %)

362 (60.4)

298 (72.0)

<0.001

2369 (81.1)

1704 (82.2)

0.330

Other lipid-lowering drugs (n,  %)

2 (0.3)

11 (2.7)

0.001

39 (1.3)

44 (2.1)

0.032

Aspirin (n,  %)

192 (32.1)

198 (47.8)

<0.001

1934 (66.2)

1441 (69.5)

0.014

  1. ACR albumin:creatinine ratio, BMI body mass index, BP blood pressure, CVD cardiovascular disease, DBP diastolic blood pressure, eGFR estimated glomerular filtration rate, HDL high-density lipoprotein, LDL low-density lipoprotein, OAD oral antidiabetic drug, SBP systolic blood pressure, SD standard deviation
  2. P values are for difference between region (Europe vs. USA) on covariates (t test) and factors (Chi square)