Table 1.
Baseline demographic and disease characteristics of the overall population from the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes clinical trial (intention to treat)
Characteristic | Placebo | Ertugliflozin, Pooled | Total |
(n=2747) | (n=5499) | (n=8246) | |
Female sex, n (%) | 844 (31) | 1633 (30) | 2477 (30) |
Age, yr | 64±8 | 64±8 | 64±8 |
HbA1c, % | 8.2±0.9 | 8.2±1.0 | 8.2±1.0 |
Duration of type 2 diabetes mellitus, yr | 13±8 | 13±8 | 13±8 |
Hemoglobin, g/dl | 14.0±1.4 | 14.0±1.4 | 14.0±1.4 |
BMI, kg/m2 | 32.0±5.5 | 31.9±5.3 | 32.0±5.4 |
eGFR, ml/min per 1.73 m2 (MDRD) | 76±21 | 76±21 | 76±21 |
UACR, mg/g | 19 (6–67) | 18 (6–69) | 19 (6–68) |
Systolic BP, mmHg | 133±14 | 133±14 | 133±14 |
Glucose-lowering agents, n (%) | |||
Insulin | 1344 (49) | 2556 (46) | 3900 (47) |
Biguanides | 2124 (77) | 4168 (76) | 6292 (76) |
Antihypertensive agents, n (%) | |||
Any antihypertensive | 2632 (96) | 5221 (95) | 7853 (95) |
RAAS inhibitor | 2239 (82) | 4447 (81) | 6686 (81) |
Diuretic | 1196 (44) | 2346 (43) | 3542 (43) |
Loop diuretic | 426 (16) | 826 (15) | 1252 (15) |
Mineralocorticoids receptor antagonists | 224 (8) | 450 (8) | 674 (8) |
Antiplatelet or antithrombotic drugs, n (%) | 2446 (89) | 4880 (89) | 7326 (89) |
Lipid-lowering agents, n (%) | 2313 (84) | 4655 (85) | 6968 (85) |
eGFR category, n (%) a | |||
eGFR G1 (eGFR≥90 ml/min per 1.73 m2) | 678 (25) | 1370 (25) | 2048 (25) |
eGFR G2 (eGFR≥60 and <90 ml/min per 1.73 m2) | 1461 (53) | 2929 (53) | 4390 (53) |
eGFR G3 (eGFR<60 ml/min per 1.73 m2) | 608 (22) | 1199 (22) | 1807 (22) |
UACR category, n (%) b | |||
Normoalbuminuria | 1597 (60) | 3186 (60) | 4783 (60) |
Microalbuminuria | 845 (31) | 1647 (31) | 2492 (31) |
Macroalbuminuria | 242 (9) | 513 (10) | 755 (9) |
KDIGO CKD risk category, n (%) c | |||
Low risk of CKD | 1307 (49) | 2609 (49) | 3916 (49) |
Moderate risk of CKD | 859 (32) | 1709 (32) | 2568 (32) |
High/very high risk of CKD | 517 (19) | 1031 (19) | 1548 (19) |
Values are mean±SD or median (interquartile range) unless otherwise stated. Table adapted from ref. 12. HbA1c, glvcated hemoglobin; BMI, body mass index; MDRD, Modification of Diet in Renal Disease; UACR, urinary albumin-to-creatinine ratio; RAAS, renin-angiotensin-aldosterone system; KDIGO CKD, Kidney Disease Improving Global Outcomes in Chronic Kidney Disease.
Participants required a baseline eGFR value for classification: n=2747 for placebo; n=5498 for ertuglifozin, pooled; n=8245 total.
Participants required a baseline UACR value for classification: n=2684 for placebo; n=5346 for ertugliflozin, pooled; n=8030 total.
Participants required baseline eGFR and UACR values for classification: n=2683 for placebo; n=5349 for ertuglifozin, pooled; n=8032 total.