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Table 1 Baseline characteristics of the study population by screening renal function strata and study drug

From: Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial

Renal function strataeGFR ≥ 60 stratumeGFR < 60 stratum
Study drugPlaceboAlogliptinp valuePlaceboAlogliptinp value
N19631983 716718 
Age (years), mean ± SD58.9 ± 9.359.1 ± 9.50.4065.8 ± 9.766.2 ± 9.40.43
 Age < 65 years1424 (72.5%)1419 (71.6%)0.49321 (44.8%)309 (43.0%)0.49
 Age ≥ 65 years539 (27.5%)564 (28.4%) 395 (55.2%)409 (57.0%) 
Male sex1427 (72.7%)1413 (71.3%)0.31396 (55.3%)415 (57.8%)0.34
Diabetes duration (years), median (IQR)6.4 (2.5, 12.0)6.2 (2.2, 11.7)0.2210.0 (4.3, 16.8)10.4 (4.4, 17.3)0.50
BMI (kg/m2), mean ± SD29.6 ± 5.729.5 ± 5.30.5929.3 ± 5.929.2 ± 5.70.56
Race  0.55  0.98
 White1460 (74.4%)1475 (74.4%) 483 (67.5%)491 (68.4%) 
 Asian360 (18.3%)369 (18.6%) 182 (25.4%)178 (24.8%) 
 Black88 (4.5%)74 (3.7%) 27 (3.8%)27 (3.8%) 
 Other55 (2.8%)65 (3.3%) 24 (3.4%)22 (3.1%) 
Geographic region  1.00  1.00
 United States, Canada312 (15.9%)314 (15.8%) 114 (15.9%)113 (15.7%) 
 Mexico, Central/South America502 (25.6%)512 (25.8%) 191 (26.7%)188 (26.2%) 
 Western Europe, Australia, New Zealand, Middle East234 (11.9%)240 (12.1%) 69 (9.6%)73 (10.2%) 
 Eastern Europe, Africa582 (29.6%)580 (29.2%) 171 (23.9%)175 (24.4%) 
 Asia/Pacific333 (17.0%)337 (17.0%) 171 (23.9%)169 (23.5%) 
Smoking327 (16.7%)300 (15.1%)0.1956 (7.8%)51 (7.1%)0.60
Hypertension1586 (80.8%)1590 (80.2%)0.63654 (91.3%)639 (89.0%)0.14
Previous MI1711 (87.2%)1748 (88.1%)0.35634 (88.5%)641 (89.3%)0.66
PCI1253 (63.8%)1248 (62.9%)0.56430 (60.1%)441 (61.4%)0.60
CABG221 (11.3%)237 (12.0%)0.50120 (16.8%)110 (15.3%)0.46
HF history480 (24.5%)495 (25.0%)0.71282 (39.4%)276 (38.4%)0.71
Previous stroke119 (6.1%)115 (5.8%)0.7374 (10.3%)80 (11.1%)0.62
PAD143 (7.3%)166 (8.4%)0.20109 (15.2%)96 (13.4%)0.31
AFib108 (5.5%)101 (5.1%)0.5779 (11.0%)88 (12.3%)0.47
eGFR* (ml/min/1.73m2), mean ± SD79.7 ± 16.979.3 ± 16.80.4347.2 ± 13.747.6 ± 13.80.57
eGFR* < 60 ml/min/1.73m2194 (9.9%)171 (8.6%)0.17599 (83.7%)601 (83.7%)0.98
eGFR < 30 ml/min/1.73m277 (10.8%)77 (10.8%)0.99
Index ACS Event Type  0.76  0.57
Myocardial Infarction1513 (77.3%)1521 (76.9%) 555 (77.6%)563 (78.9%) 
Unstable Angina445 (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)0.6844.0 (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)0.4412.8 (6.4, 27.7)14.0 (7.1, 30.2)0.08
Heart rate (bpm), mean ± SD71.4 ± 10.871.6 ± 10.40.5670.7 ± 11.171.0 ± 11.40.55
SBP (mmHg), mean ± SD128.5 ± 16.7127.9 ± 15.80.21131.1 ± 17.6131.2 ± 17.20.93
DBP (mmHg), mean ± SD76.9 ± 9.576.6 ± 9.40.4175.5 ± 10.175.4 ± 10.30.95
Total cholesterol (mg/dL), mean ± SD153.5 ± 42.2151.7 ± 43.10.19158.6 ± 46.4159.8 ± 46.60.62
LDL cholesterol (mg/dL), mean ± SD78.1 ± 33.676.6 ± 33.20.1781.0 ± 37.283.4 ± 38.60.24
HDL cholesterol (mg/dL), mean ± SD42.8 ± 10.043.2 ± 10.70.2543.8 ± 11.143.1 ± 11.20.25
Triglycerides (mg/dL), mean ± SD165.5 ± 108.7160.9 ± 105.50.18168.8 ± 98.2167.7 ± 90.80.84
UACR (mg/g creat.), mean ± SD17.6 ± 54.118.1 ± 69.10.8367.7 ± 152.174.1 ± 166.60.53
C-reactive protein (mg/dL), mean ± SD5.1 ± 12.15.1 ± 12.50.947.0 ± 14.96.8 ± 18.80.79
Antiplatelet agents1911 (97.4%)1933 (97.5%)0.80691 (96.5%)697 (97.1%)0.54
Beta-blockers1624 (82.7%)1623 (81.8%)0.47579 (80.9%)585 (81.5%)0.77
ACEi/ARBs1641 (83.6%)1626 (82.0%)0.18569 (79.5%)575 (80.1%)0.77
Statins1796 (91.5%)1798 (90.7%)0.37624 (87.2%)648 (90.3%)0.064
Antidiabetic agents1948 (99.2%)1968 (99.2%)0.98701 (97.9%)708 (98.6%)0.31
Insulin550 (28.0%)526 (26.5%)0.29262 (36.6%)267 (37.2%)0.82
Metformin1437 (73.2%)1424 (71.8%)0.33368 (51.4%)333 (46.4%)0.057
Thiazolidinediones42 (2.1%)41 (2.1%)0.8722 (3.1%)26 (3.6%)0.56
Sulfonylureas927 (47.2%)946 (47.7%)0.76310 (43.3%)320 (44.6%)0.63
Calcium channel blockers388 (19.8%)375 (18.9%)0.50223 (31.1%)211 (29.4%)0.47
Diuretics (any)616 (31.4%)624 (31.5%)0.95393 (54.9%)381 (53.1%)0.49
  1. 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
  2. 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
  3. *eGFR at randomization, that occurred 9 (7–13) days after the baseline visit