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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)
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Diabetology & Metabolic Syndrome

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