Table 1.
Baseline characteristics of randomized participants, by diabetes status
| DM | |||
|---|---|---|---|
| Overall | Yes | No | |
| Characteristics | (N = 6609) | (n = 3039) | (n = 3570) |
| Demographics | |||
| Age at randomization (years) | |||
| Mean (SD) | 63.8 (13.9) | 68.6 (9.9) | 59.8 (15.4) |
| <60 | 2252 (34) | 545 (18) | 1707 (48) |
| ≥60–<70 | 1720 (26) | 969 (32) | 751 (21) |
| ≥70 | 2637 (40) | 1525 (50) | 1112 (31) |
| Sex | |||
| Male | 4417 (67) | 2044 (67) | 2373 (66) |
| Female | 2192 (33) | 995 (33) | 1197 (34) |
| Region | |||
| Europe (UK, Germany, Italy) | 2648 (40) | 1050 (35) | 1598 (45) |
| North America (USA, Canada) | 1717 (26) | 1066 (35) | 651 (18) |
| China, Malaysia | 1632 (25) | 632 (21) | 1000 (28) |
| Japan | 612 (9) | 291 (10) | 321 (9) |
| Race (all regions) | |||
| White | 3859 (58) | 1809 (60) | 2050 (57) |
| Black | 262 (4) | 173 (6) | 89 (2) |
| Asian | 2393 (36) | 1008 (33) | 1385 (39) |
| Mixed | 21 (<1) | 10 (<1) | 11 (<1) |
| Other | 74 (1) | 39 (1) | 35 (1) |
| Prior disease | |||
| Prior DM | |||
| Yes | 3039 (46) | 3039 (100) | |
| No | 3570 (54) | 3570 (100) | |
| Prior DM type | |||
| Type 1 | 69 (1) | 69 (2) | |
| Type 2 | 2934 (44) | 2934 (97) | |
| Other/unknown | 36 (1) | 36 (1) | |
| History of cardiovascular diseasea | |||
| Yes | 1765 (27) | 1104 (36) | 661 (19) |
| No | 4844 (73) | 1935 (64) | 2909 (81) |
| History of heart failure | |||
| Yes | 658 (10) | 431 (14) | 227 (6) |
| No or missing | 5951 (90) | 2608 (86) | 3343 (94) |
| History of peripheral arterial disease | |||
| Yes | 470 (7) | 318 (10) | 152 (4) |
| No | 6139 (93) | 2721 (90) | 3418 (96) |
| Clinical measurements | |||
| Systolic BP (mmHg) | |||
| Mean (SD) | 136.5 (18.3) | 139.2 (18.8) | 134.3 (17.5) |
| <130 | 2398 (36) | 960 (32) | 1438 (40) |
| ≥130–<145 | 2189 (33) | 958 (32) | 1231 (34) |
| ≥145 | 2022 (31) | 1121 (37) | 901 (25) |
| Diastolic BP (mmHg) | |||
| Mean (SD) | 78.1 (11.8) | 75.5 (11.4) | 80.2 (11.7) |
| <75 | 2580 (39) | 1471 (48) | 1109 (31) |
| ≥75–<85 | 2052 (31) | 873 (29) | 1179 (33) |
| ≥85 | 1977 (30) | 695 (23) | 1282 (36) |
| Body mass index (kg/m2) | |||
| Mean (SD) | 29.7 (6.8) | 31.8 (7.1) | 28.0 (5.9) |
| <25 | 1620 (25) | 464 (15) | 1156 (32) |
| ≥25–<30 | 2296 (35) | 929 (31) | 1367 (38) |
| ≥30 | 2677 (41) | 1636 (54) | 1041 (29) |
| Missing | 16 (<1) | 10 (<1) | 6 (<1) |
| Laboratory measurements | |||
| Glycosylated haemoglobin (mmol/mol) | |||
| Mean (SD) | 45.0 (13.6) | 54.9 (14.3) | 36.6 (4.0) |
| <39 | 2683 (41) | 209 (7) | 2474 (69) |
| ≥39–<48 | 1837 (28) | 805 (26) | 1032 (29) |
| ≥48 | 1978 (30) | 1978 (65) | |
| Missing | 111 (2) | 47 (2) | 64 (2) |
| <75 | 2740 (90) | ||
| ≥75 | 252 (8) | ||
| NT-proBNP (ng/L) | |||
| Median (IQR) | 190.3 (93.5–477.7) | 238.3 (106.7–604.0) | 163.3 (83.9–388.9) |
| <110 | 2391 (36) | 899 (30) | 1492 (42) |
| ≥110–<330 | 2061 (31) | 967 (32) | 1094 (31) |
| ≥330 | 1979 (30) | 1119 (37) | 860 (24) |
| Missing | 178 (3) | 54 (2) | 124 (3) |
| Haematocrit (%) | |||
| Mean (SD) | 39.1 (5.1) | 38.4 (5.1) | 39.7 (5.1) |
| <37% | 1818 (28) | 938 (31) | 880 (25) |
| ≥37–<41% | 1888 (29) | 878 (29) | 1010 (28) |
| ≥41% | 2252 (34) | 843 (28) | 1409 (39) |
| Missing | 651 (10) | 380 (13) | 271 (8) |
| eGFR (mL/min/1.73 m2)b | |||
| Mean (SD) | 37.5 (14.8) | 36.0 (13.9) | 38.7 (15.4) |
| <30 | 2280 (34) | 1148 (38) | 1132 (32) |
| ≥30–<45 | 2905 (44) | 1359 (45) | 1546 (43) |
| ≥45 | 1424 (22) | 532 (18) | 892 (25) |
| uACR (mg/g)b | |||
| Median (IQR) | 412 (94–1190) | 348 (68–1293) | 461 (128–1117) |
| <30 | 1332 (20) | 649 (21) | 683 (19) |
| ≥30–<300 | 1862 (28) | 941 (31) | 921 (26) |
| ≥300 | 3415 (52) | 1449 (48) | 1966 (55) |
| KDIGO risk category | |||
| Low, moderate or high | 1698 (26) | 730 (24) | 968 (27) |
| Very high | 4911 (74) | 2309 (76) | 2602 (73) |
| RAS inhibitor use | |||
| uACR <200 mg/g | |||
| No RAS inhibitor | 510 (19) | 217 (16) | 293 (22) |
| RAS inhibitor | 2214 (81) | 1179 (84) | 1035 (78) |
| uACR ≥200 mg/g | |||
| No RAS inhibitor | 486 (13) | 237 (14) | 249 (11) |
| RAS inhibitor | 3399 (87) | 1406 (86) | 1993 (89) |
Values are presented as n (%) unless stated otherwise.
a
Defined as a history of myocardial infarction, heart failure, stroke, transient ischaemic attack or peripheral arterial disease.
b
Uses central measurement taken at the randomization visit or most recent local laboratory result before randomization.
Prior DM is defined as a participant-reported history of diabetes of any type, use of glucose-lowering medication or baseline HbA1c ≥48 mmol/mol at the randomization visit.
NT-proBNP, N-terminal pro B-type natriuretic peptide.