Table I.
Baseline characteristics by enrolling region
| All Regions N = 14,752 | North America N = 3708 | Latin America N = 2727 | Asia Pacific N = 1529 | Europe N = 6788 | |
|---|---|---|---|---|---|
|
| |||||
| Age (y) | 62.7 (56.4, 68.8) | 64.1 (57.4, 70.3) | 61.5 (55.0, 68.0) | 61.4 (55.1, 67.4) | 62.7 (56.8, 68.6) |
| Min/max | 21.1, 92.6 | 23.6, 89.9 | 24.4, 92.6 | 25.7, 87.9 | 21.1, 88.7 |
| <40 y | 205 (1.4%) | 56 (1.5%) | 55 (2.0%) | 30 (2.0%) | 64 (0.9%) |
| 40 to <65 y | 8606 (58.3%) | 1912 (51.6%) | 1689 (61.9%) | 954 (62.4%) | 4051 (59.7%) |
| 65 to 75 y | 4690 (31.8%) | 1294 (34.9%) | 777 (28.5%) | 455 (29.8%) | 2164 (31.9%) |
| >75 y | 1251 (8.5%) | 446 (12.0%) | 206 (7.6%) | 90 (5.9%) | 509 (7.5%) |
| Women | 5604 (38.0%) | 1142 (30.8%) | 1341 (49.2%) | 574 (37.5%) | 2547 (37.5%) |
| Race | |||||
| White | 11,175 (75.8%) | 2800 (75.6%) | 1494 (54.8%) | 300 (19.6%) | 6581 (97.0%) |
| Asian | 1452 (9.8%) | 120 (3.2%) | 7 (0.3%) | 1212 (79.3%) | 113 (1.7%) |
| Hispanic | 1134 (7.7%) | 329 (8.9%) | 799 (29.3%) | 0 (0.0%) | 6 (0.1%) |
| Black | 878 (6.0%) | 430 (11.6%) | 374 (13.8%) | 1 (0.1%) | 73 (1.1%) |
| Indian or Alaska Native | 73 (0.5%) | 12 (0.3%) | 51 (1.9%) | 0 (0.0%) | 10 (0.1%) |
| Pacific Islander or Hawaiian | 35 (0.2%) | 14 (0.4%) | 1 (0.0%) | 16 (1.0%) | 4 (0.1%) |
| Ethnicity | |||||
| Hispanic or Latino | 3026 (20.5%) | 366 (9.9%) | 2564 (94.0%) | 7 (0.5%) | 89 (1.3%) |
| Non-Hispanic or Latino | 11,724 (79.5%) | 3340 (90.1%) | 163 (6.0%) | 1522 (99.5%) | 6699 (98.7%) |
| Diabetes duration (y) | 12 (7, 18) | 13 (7, 19) | 11 (6, 18) | 11 (7, 18) | 11 (7, 17) |
| <5 y | 2018 (13.7%) | 489 (13.2%) | 454 (16.7%) | 207 (13.6%) | 868 (12.8%) |
| ≥5 to <15 y | 7264 (49.4%) | 1693 (45.9%) | 1248 (45.8%) | 761 (50.0%) | 3562 (52.7%) |
| ≥15 y | 5420 (36.9%) | 1510 (40.9%) | 1022 (37.5%) | 554 (36.4%) | 2334 (34.5%) |
| History of cardiovascular disease | |||||
| Coronary artery disease | 7501 (69.6%) | 2307 (86.7%) | 1083 (52.1%) | 811 (70.8%) | 3300 (67.4%) |
| Cerebrovascular disease | 2419 (22.4%) | 538 (20.2%) | 267 (12.8%) | 302 (26.4%) | 1312 (26.8%) |
| Peripheral artery disease | 2540 (23.6%) | 368 (13.8%) | 918 (44.1%) | 151 (13.2%) | 1103 (22.5%) |
| History of retinopathy | 2511 (17.0%) | 465 (12.5%) | 347 (12.7%) | 242 (15.8%) | 1457 (21.5%) |
| History of heart failure | 2385 (16.2%) | 403 (10.9%) | 241 (8.8%) | 77 (5.0%) | 1664 (24.5%) |
| NYHA class | |||||
| I | 736 (30.9%) | 143 (35.6%) | 106 (44.0%) | 44 (57.1%) | 443 (26.7%) |
| II | 1333 (55.9%) | 204 (50.7%) | 114 (47.3%) | 28 (36.4%) | 987 (59.4%) |
| III | 301 (12.6%) | 51 (12.4%) | 19 (7.9%) | 5 (6.5%) | 226 (13.6%) |
| IV | 13 (0.5%) | 5 (1.2%) | 2 (0.8%) | 0 (0.0%) | 6 (0.4%) |
| Most recent assessment of LV function (ejection fraction) | |||||
| Normal (>55%) | 2924 (59.8%) | 911 (60.2%) | 331 (62.5%) | 273 (66.1%) | 1409 (57.9%) |
| Mild dysfunction (40–55%) | 1497 (30.7%) | 432 (28.5%) | 135 (25.5%) | 95 (23.0%) | 835 (34.3%) |
| Moderate dysfunction (25–39%) | 388 (7.9%) | 134 (8.9%) | 49 (9.2%) | 36 (8.7%) | 169 (7.0%) |
| Severe dysfunction (<25%) | 81 (1.7%) | 37 (2.4%) | 15 (2.8%) | 9 (2.2%) | 20 (0.8%) |
| Systolic blood pressure (mmHg) | 135 (124, 145) | 130 (120, 140) | 135 (122, 149) | 131 (121, 144) | 138 (129, 147) |
| Diastolic blood pressure (mmHg) | 80 (70–85) | 75 (68–81) | 80 (71–86) | 79 (70–84) | 80 (73–86) |
| Heart rate (bpm) | 72 (66, 80) | 72 (64, 79) | 72 (65, 80) | 74 (68, 81) | 72 (67, 80) |
| Body mass index (kg/m2) | 31.8 (28.2, 36.2) | 33.6 (29.7, 38.3) | 29.8 (26.8, 33.3) | 27.3 (24.5, 31.2) | 32.7 (29.4, 36.9) |
| <30 kg/m2 | 5355 (36.7%) | 976 (26.8%) | 1388 (51.1%) | 1036 (69.0%) | 1955 (29.0%) |
| ≥30 kg/m2 | 9247 (63.3%) | 2668 (73.2%) | 1328 (48.9%) | 465 (31.0%) | 4786 (71.0%) |
| HbA1c (%) | 8.0 (7.3, 8.9) | 7.9 (7.3, 8.7) | 8.1 (7.4, 9.1) | 8.0 (7.4, 8.9) | 8.0 (7.3, 8.9) |
| Min/max | 5.6, 12.7 | 5.6, 12.7 | 5.9, 10.9 | 6.1, 12.6 | 6.0, 11.7 |
| Mean (SD) in patients <8% | 7.3 (0.4) | 7.3 (0.4) | 7.3 (0.4) | 7.3 (0.4) | 7.3 (0.4) |
| Mean (SD) in patients ≥8% | 8.9 (0.6) | 8.9 (0.6) | 9.0 (0.6) | 8.9 (0.7) | 8.9 (0.6) |
| LDL (mg/dL) | 88 (66, 116) | 76 (60, 98) | 100 (74, 128) | 84 (65, 110) | 93 (71, 124) |
| eGFR via MDRD (mL/min per 1.73 m2) | 79 (64, 96) | 78 (62, 95) | 78 (64, 93) | 81 (64, 99) | 81 (66, 96) |
| >90 | 5036 (34.2%) | 1214 (32.7%) | 854 (31.3%) | 567 (37.1%) | 2401 (35.4%) |
| 60–89 | 6953 (47.2%) | 1684 (45.4%) | 1342 (49.2%) | 687 (45.0%) | 3240 (47.8%) |
| 30–59 | 2743 (18.6%) | 807 (21.8%) | 527 (19.3%) | 270 (17.7%) | 1139 (16.8%) |
| Anti-DM therapies | |||||
| Metformin | 11,289 (76.5%) | 2617 (70.6%) | 2250 (82.5%) | 1164 (76.1%) | 5258 (77.5%) |
| Sulfonylurea | 5402 (36.6%) | 1416 (38.2%) | 1144 (42.0%) | 659 (43.1%) | 2183 (32.2%) |
| Thiazolidinedione | 579 (3.9%) | 342 (9.2%) | 21 (0.8%) | 74 (4.8%) | 142 (2.1%) |
| DPP-4 inhibitor | 2202 (14.9%) | 641 (17.3%) | 211 (7.7%) | 240 (15.7%) | 1110 (16.4%) |
| SGLT-2 inhibitor | 77 (0.9%) | 15 (0.9%) | 10 (0.5%) | 3 (0.3%) | 49 (1.3%) |
| Insulin | 6819 (46.2%) | 1591 (42.9%) | 1215 (44.6%) | 698 (45.7%) | 3315 (48.8%) |
| And 0-2 oral AHAs | 6738 (45.7%) | 1575 (42.5%) | 1202 (44.1%) | 689 (45.1%) | 3272 (48.2%) |
| And >2 oral AHAs | 81 (0.5%) | 16 (0.4%) | 13 (0.5%) | 9 (0.6%) | 43 (0.6%) |
| Monotherapy (including oral agents and insulin) | 2687 (32.0%) | 572 (33.7%) | 640 (32.0%) | 236 (25.0%) | 1239 (33.0%) |
| 2 oral therapies | 1914 (46.8%) | 338 (46.3%) | 569 (53.7%) | 195 (47.2%) | 812 (43.1%) |
| No glucose lowering therapy | 125 (1.5%) | 35 (2.1%) | 24 (1.2%) | 18 (1.9%) | 48 (1.3%) |
| Cardiovascular medications | |||||
| Aspirin | 9372 (63.5%) | 2685 (72.5%) | 1594 (58.5%) | 920 (60.2%) | 4173 (61.5%) |
| Thienopyridines | 2521 (17.1%) | 730 (19.7%) | 333 (12.2%) | 322 (21.1%) | 1136 (16.7%) |
| Any anti-platelets | 10,310 (69.9%) | 2871 (77.5%) | 1659 (60.8%) | 1089 (71.2%) | 4691 (69.1%) |
| ACEI or ARB | 11,386 (77.2%) | 2881 (77.7%) | 1938 (71.1%) | 1029 (67.3%) | 5538 (81.6%) |
| β-Blockers | 8208 (55.6%) | 2166 (58.4%) | 1085 (39.8%) | 714 (46.7%) | 4243 (62.5%) |
| Calcium-channel blocker | 4701 (31.9%) | 1024 (27.6%) | 609 (22.3%) | 592 (38.7%) | 2476 (36.5%) |
| Any anti-hypertensive | 13,318 (90.3%) | 3424 (92.4%) | 2220 (81.4%) | 1320 (86.3%) | 6354 (93.6%) |
| Statin | 10,836 (73.5%) | 3094 (83.5%) | 1617 (59.3%) | 1143 (74.8%) | 4982 (73.4%) |
| Any lipid-lowering Rx | 11,364 (77.0%) | 3210 (86.6%) | 1746 (64.0%) | 1197 (78.3%) | 5211 (76.8%) |
AHA, Anti-hyperglycemic agents; HbA1c, hemoglobin A1c; LDL, low density lipoprotein; eGFR, estimated glomerular filtration rate; MDRD, modification of diet in renal disease; DPP-IV, dipeptidyl peptidase; SGLT-2, sodium-glucose co-transporter 2; ACEI, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker.