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 |
Stratification according to renal function was performed at the baseline visit, as follows: (1) “normal renal function” stratum if eGFR ≥60 ml/min/1.73m2 or (2) “impaired renal function” stratum if eGFR < 60 ml/min/1.73m2
MI myocardial infarction, PCI percutaneous coronary intervention, CABG coronary-artery bypass grafting, HF heart failure, PAD peripheral artery disease, AFib atrial fibrillation, eGFR estimated glomerular filtration rate, ACS acute coronary syndrome, SBP systolic blood pressure, DBP diastolic blood pressure, ACEi/ARBs angiotensin converting enzyme inhibitors/angiotensin receptor blockers, UACR urinary albumin-to-creatinine ratio
*eGFR at randomization, that occurred 9 (7–13) days after the baseline visit