TABLE 1.
Baseline characteristics of the participants by risk marker improvement subgroups
| Baseline | G0 | G1 | G2 | G3 | G4 | Total |
|---|---|---|---|---|---|---|
| No. of participants, n (%) a | 1055 (9.0) | 3162 (27.1) | 3540 (30.3) | 2515 (21.5) | 1406 (12.0) | 11 678 (100) |
| Treated with liraglutide or semaglutide, n (%) | 322 (30.5) | 1202 (38.0) | 1727 (48.8) | 1550 (61.6) | 1059 (75.3) | 5860 (50.2) |
| Placebo, n (%) | 733 (69.5) | 1960 (62.0) | 1813 (51.2) | 965 (38.4) | 347 (24.7) | 5818 (49.8) |
| Age, years | 64.2 ± 7.4 | 64.3 ± 7.1 | 64.2 ± 7.2 | 64.4 ± 7.2 | 64.5 ± 7.2 | 64.3 ± 7.2 |
| Female, n (%) | 320 (30.3) | 1061 (33.6) | 1278 (36.1) | 991 (39.4) | 613 (43.6) | 4263 (36.5) |
| HbA1c, %d | 8.2 ± 1.2 | 8.5 ± 1.4 | 8.8 ± 1.6 | 8.8 ± 1.5 | 8.8 ± 1.4 | 8.7 ± 1.5 |
| HbA1c, mmol/mol | 66.0 ± 12.9 | 69.6 ± 15.5 | 72.5 ± 17.4 | 73.0 ± 16.7 | 72.8 ± 15.6 | 71.3 ± 16.3 |
| Body weight, kg d | 91.1 ± 20.7 | 91.6 ± 20.6 | 91.4 ± 20.6 | 92.4 ± 20.9 | 92.2 ± 21.5 | 91.7 ± 20.8 |
| Diabetes duration, years, median (IQR) | 11.5 (6.8‐16.9) | 11.8 (7.0‐17.7) | 11.6 (7.0‐17.1) | 11.7 (7.1‐17.2) | 12.4 (7.4‐18.3) | 11.8 (7.1‐17.5) |
| Current smoker, n (%) | 125 (11.8) | 413 (13.1) | 376 (10.6) | 301 (12.0) | 170 (12.1) | 1385 (11.9) |
| SBP, mmHg d | 131 ± 16 | 133 ± 17 | 136 ± 18 | 139 ± 18 | 141 ± 18 | 136 ± 17 |
| LDL‐C, mg/dl | 84.6 ± 32.5 | 84.3 ± 33.3 | 89.5 ± 35.5 | 92.6 ± 37.4 | 101.4 ± 41.6 | 89.8 ± 36.3 |
| LDL‐C, mmol/L d | 2.2 ± 0.8 | 2.2 ± 0.9 | 2.3 ± 0.9 | 2.4 ± 1.0 | 2.6 ± 1.1 | 2.3 ± 0.9 |
|
eGFR (CKD‐EPI), ml/min/1.73 m2 d |
81.4 ± 21.3 | 80.6 ± 21.6 | 80.4 ± 21.5 | 79.7 ± 22.0 | 79.2 ± 22.0 | 80.3 ± 21.7 |
| UACR, median (IQR) d | 11.9 (3.4‐64.8) | 12.5 (3.9‐57.5) | 14.6 (4.6‐63.1) | 17.2 (5.6‐69.9) | 22.3 (7.5‐96.0) | 15.3 (4.6‐67.5) |
| Established CVD, n (%) | 873 (82.7) | 2559 (80.9) | 2863 (80.9) | 2059 (81.9) | 1156 (82.2) | 9510 (81.4) |
| Presence of CVD risk factor, n (%) a , b | 182 (17.3) | 603 (19.1) | 677 (19.1) | 456 (18.1) | 250 (17.8) | 2168 (18.6) |
| Lipid‐lowering treatment, n (%) | 820 (77.7) | 2431 (76.9) | 2728 (77.1) | 1886 (75.0) | 1023 (72.8) | 8888 (76.1) |
| RAAS inhibition treatment, n (%) | 857 (81.2) | 2548 (80.6) | 2883 (81.4) | 2032 (80.8) | 1123 (79.9) | 9443 (80.9) |
| Metformin treatment, n (%) | 796 (75.5) | 2486 (78.6) | 2727 (77.0) | 1887 (75.0) | 1033 (73.5) | 8929 (76.5) |
| Insulin treatment, n (%) | 487 (46.2) | 1498 (47.4) | 1550 (43.8) | 1111 (44.2) | 631 (44.9) | 5277 (45.2) |
| SGLT‐2 inhibitor treatment, n (%) c | 1 (<0.1) | 0 (0.0) | 2 (<0.1) | 1 (<0.1) | 1 (<0.1) | 5 (<0.1) |
| Aspirin treatment, n (%) | 682 (64.6) | 2022 (63.9) | 2264 (64.0) | 1576 (62.7) | 868 (61.7) | 7412 (63.5) |
Note: Adapted from Zobel EH et al. The importance of addressing multiple risk markers in type 2 diabetes: results from the LEADER and SUSTAIN 6 trials.12. Abstract/FC 058 ©ERA‐EDTA GROUP. Reproduced by permission of Oxford University Press on behalf of the ERA‐EDTA. Table is not published under this article's licence and permission must be sought for any form of reuse.
Pooled data from the LEADER and SUSTAIN 6 trials. Data are presented as mean ± standard derivation, unless stated otherwise. Participants were categorized according to number of risk markers with an improvement at year 1 [none (group G0), one (G1), two (G2), three (G3) and four or more (G4)].
Abbreviations: CKD‐EPI, Chronic Kidney Disease Epidemiology Collaboration; CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; IQR, interquartile range; LDL‐C, low‐density lipoprotein‐cholesterol; RAAS, renin‐angiotensin‐aldosterone system; SBP, systolic blood pressure; SGLT‐2, sodium‐glucose cotransporter‐2; UACR, urinary albumin‐to‐creatinine ratio.
Calculated as a percentage of the overall total (all other percentages were calculated out of the risk marker improvement subgroups).
Presence of CVD risk factor was defined as persistent microalbuminuria (30‐299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrocardiogram or imaging, left ventricular systolic or diastolic dysfunction by imaging, or ankle/brachial index <0.9.
SGLT‐2 inhibitors were not marketed before randomization in the LEADER trial, hence relatively few participants in the pooled population received this medication at baseline.
These parameters are risk markers that were evaluated in this post‐hoc analysis.