Table 1 Baseline characteristics of the study population by screening renal function strata and study drug
Renal function strata | eGFR ≥ 60 stratum | eGFR < 60 stratum | ||||
|---|---|---|---|---|---|---|
Study drug | Placebo | Alogliptin | p value | Placebo | Alogliptin | p value |
N | 1963 | 1983 | 716 | 718 | ||
Age (years), mean ± SD | 58.9 ± 9.3 | 59.1 ± 9.5 | 0.40 | 65.8 ± 9.7 | 66.2 ± 9.4 | 0.43 |
Age < 65 years | 1424 (72.5%) | 1419 (71.6%) | 0.49 | 321 (44.8%) | 309 (43.0%) | 0.49 |
Age ≥ 65 years | 539 (27.5%) | 564 (28.4%) | 395 (55.2%) | 409 (57.0%) | ||
Male sex | 1427 (72.7%) | 1413 (71.3%) | 0.31 | 396 (55.3%) | 415 (57.8%) | 0.34 |
Diabetes duration (years), median (IQR) | 6.4 (2.5, 12.0) | 6.2 (2.2, 11.7) | 0.22 | 10.0 (4.3, 16.8) | 10.4 (4.4, 17.3) | 0.50 |
BMI (kg/m2), mean ± SD | 29.6 ± 5.7 | 29.5 ± 5.3 | 0.59 | 29.3 ± 5.9 | 29.2 ± 5.7 | 0.56 |
Race | 0.55 | 0.98 | ||||
White | 1460 (74.4%) | 1475 (74.4%) | 483 (67.5%) | 491 (68.4%) | ||
Asian | 360 (18.3%) | 369 (18.6%) | 182 (25.4%) | 178 (24.8%) | ||
Black | 88 (4.5%) | 74 (3.7%) | 27 (3.8%) | 27 (3.8%) | ||
Other | 55 (2.8%) | 65 (3.3%) | 24 (3.4%) | 22 (3.1%) | ||
Geographic region | 1.00 | 1.00 | ||||
United States, Canada | 312 (15.9%) | 314 (15.8%) | 114 (15.9%) | 113 (15.7%) | ||
Mexico, Central/South America | 502 (25.6%) | 512 (25.8%) | 191 (26.7%) | 188 (26.2%) | ||
Western Europe, Australia, New Zealand, Middle East | 234 (11.9%) | 240 (12.1%) | 69 (9.6%) | 73 (10.2%) | ||
Eastern Europe, Africa | 582 (29.6%) | 580 (29.2%) | 171 (23.9%) | 175 (24.4%) | ||
Asia/Pacific | 333 (17.0%) | 337 (17.0%) | 171 (23.9%) | 169 (23.5%) | ||
Smoking | 327 (16.7%) | 300 (15.1%) | 0.19 | 56 (7.8%) | 51 (7.1%) | 0.60 |
Hypertension | 1586 (80.8%) | 1590 (80.2%) | 0.63 | 654 (91.3%) | 639 (89.0%) | 0.14 |
Previous MI | 1711 (87.2%) | 1748 (88.1%) | 0.35 | 634 (88.5%) | 641 (89.3%) | 0.66 |
PCI | 1253 (63.8%) | 1248 (62.9%) | 0.56 | 430 (60.1%) | 441 (61.4%) | 0.60 |
CABG | 221 (11.3%) | 237 (12.0%) | 0.50 | 120 (16.8%) | 110 (15.3%) | 0.46 |
HF history | 480 (24.5%) | 495 (25.0%) | 0.71 | 282 (39.4%) | 276 (38.4%) | 0.71 |
Previous stroke | 119 (6.1%) | 115 (5.8%) | 0.73 | 74 (10.3%) | 80 (11.1%) | 0.62 |
PAD | 143 (7.3%) | 166 (8.4%) | 0.20 | 109 (15.2%) | 96 (13.4%) | 0.31 |
AFib | 108 (5.5%) | 101 (5.1%) | 0.57 | 79 (11.0%) | 88 (12.3%) | 0.47 |
eGFR* (ml/min/1.73m2), mean ± SD | 79.7 ± 16.9 | 79.3 ± 16.8 | 0.43 | 47.2 ± 13.7 | 47.6 ± 13.8 | 0.57 |
eGFR* < 60 ml/min/1.73m2 | 194 (9.9%) | 171 (8.6%) | 0.17 | 599 (83.7%) | 601 (83.7%) | 0.98 |
eGFR < 30 ml/min/1.73m2 | – | – | – | 77 (10.8%) | 77 (10.8%) | 0.99 |
Index ACS Event Type | 0.76 | 0.57 | ||||
Myocardial Infarction | 1513 (77.3%) | 1521 (76.9%) | 555 (77.6%) | 563 (78.9%) | ||
Unstable Angina | 445 (22.7%) | 458 (23.1%) | 160 (22.4%) | 151 (21.1%) | ||
Time from index ACS to randomization, median (IQR) | 45.0 (29.0, 63.0) | 44.0 (30.0, 63.0) | 0.68 | 44.0 (30.0, 65.0) | 43.0 (29.0, 66.0) | 0.56 |
Troponin I (ng/L), median (IQR) | 7.8 (4.3, 16.5) | 7.7 (3.8, 17.0) | 0.44 | 12.8 (6.4, 27.7) | 14.0 (7.1, 30.2) | 0.08 |
Heart rate (bpm), mean ± SD | 71.4 ± 10.8 | 71.6 ± 10.4 | 0.56 | 70.7 ± 11.1 | 71.0 ± 11.4 | 0.55 |
SBP (mmHg), mean ± SD | 128.5 ± 16.7 | 127.9 ± 15.8 | 0.21 | 131.1 ± 17.6 | 131.2 ± 17.2 | 0.93 |
DBP (mmHg), mean ± SD | 76.9 ± 9.5 | 76.6 ± 9.4 | 0.41 | 75.5 ± 10.1 | 75.4 ± 10.3 | 0.95 |
Total cholesterol (mg/dL), mean ± SD | 153.5 ± 42.2 | 151.7 ± 43.1 | 0.19 | 158.6 ± 46.4 | 159.8 ± 46.6 | 0.62 |
LDL cholesterol (mg/dL), mean ± SD | 78.1 ± 33.6 | 76.6 ± 33.2 | 0.17 | 81.0 ± 37.2 | 83.4 ± 38.6 | 0.24 |
HDL cholesterol (mg/dL), mean ± SD | 42.8 ± 10.0 | 43.2 ± 10.7 | 0.25 | 43.8 ± 11.1 | 43.1 ± 11.2 | 0.25 |
Triglycerides (mg/dL), mean ± SD | 165.5 ± 108.7 | 160.9 ± 105.5 | 0.18 | 168.8 ± 98.2 | 167.7 ± 90.8 | 0.84 |
UACR (mg/g creat.), mean ± SD | 17.6 ± 54.1 | 18.1 ± 69.1 | 0.83 | 67.7 ± 152.1 | 74.1 ± 166.6 | 0.53 |
C-reactive protein (mg/dL), mean ± SD | 5.1 ± 12.1 | 5.1 ± 12.5 | 0.94 | 7.0 ± 14.9 | 6.8 ± 18.8 | 0.79 |
Antiplatelet agents | 1911 (97.4%) | 1933 (97.5%) | 0.80 | 691 (96.5%) | 697 (97.1%) | 0.54 |
Beta-blockers | 1624 (82.7%) | 1623 (81.8%) | 0.47 | 579 (80.9%) | 585 (81.5%) | 0.77 |
ACEi/ARBs | 1641 (83.6%) | 1626 (82.0%) | 0.18 | 569 (79.5%) | 575 (80.1%) | 0.77 |
Statins | 1796 (91.5%) | 1798 (90.7%) | 0.37 | 624 (87.2%) | 648 (90.3%) | 0.064 |
Antidiabetic agents | 1948 (99.2%) | 1968 (99.2%) | 0.98 | 701 (97.9%) | 708 (98.6%) | 0.31 |
Insulin | 550 (28.0%) | 526 (26.5%) | 0.29 | 262 (36.6%) | 267 (37.2%) | 0.82 |
Metformin | 1437 (73.2%) | 1424 (71.8%) | 0.33 | 368 (51.4%) | 333 (46.4%) | 0.057 |
Thiazolidinediones | 42 (2.1%) | 41 (2.1%) | 0.87 | 22 (3.1%) | 26 (3.6%) | 0.56 |
Sulfonylureas | 927 (47.2%) | 946 (47.7%) | 0.76 | 310 (43.3%) | 320 (44.6%) | 0.63 |
Calcium channel blockers | 388 (19.8%) | 375 (18.9%) | 0.50 | 223 (31.1%) | 211 (29.4%) | 0.47 |
Diuretics (any) | 616 (31.4%) | 624 (31.5%) | 0.95 | 393 (54.9%) | 381 (53.1%) | 0.49 |