Table 1.
Baseline characteristics of patients with and without heart failure
| History of Heart Failure | |||
|---|---|---|---|
| Yes N=2389 | No N=12,362 | P-value | |
| Age at randomization (years)* | <0.001 | ||
| Median (Q1, Q3) | 64.0 (58.0, 69.0) | 62.0 (55.0, 68.0) | |
| Sex | 0.007 | ||
| Male | 1540 / 2389 (64.5%) | 7609 / 12362 (61.6%) | |
| Race | <0.001 | ||
| White | 2120 / 2389 (88.7%) | 9055 / 12357 (73.3%) | |
| Black | 83 / 2389 (3.5%) | 795 / 12357 (6.4%) | |
| Asian | 79 / 2389 (3.3%) | 1373 / 12357 (11.1%) | |
| Indian (American) or Alaska Native | 5 / 2389 (0.2%) | 68 / 12357 (0.6%) | |
| Native Hawaiian or Other Pacific Islander | 4 / 2389 (0.2%) | 31 / 12357 (0.3%) | |
| Hispanic | 98 / 2389 (4.1%) | 1035 / 12357 (8.4%) | |
| Region | <0.001 | ||
| Europe | 1666 / 2389 (69.7%) | 5122 / 12362 (41.4%) | |
| North America | 403 / 2389 (16.9%) | 3305 / 12362 (26.7%) | |
| Latin America | 243 / 2389 (10.2%) | 2483 / 12362 (20.1%) | |
| Asia Pacific | 77 / 2389 (3.2%) | 1452 / 12362 (11.7%) | |
| Prior CV event at randomization | <0.001 | ||
| Yes | 2067 / 2389 (86.5%) | 8714 / 12362 (70.5%) | |
| No | 322 / 2389 (13.5%) | 3648 / 12362 (29.5%) | |
| Coronary artery disease | 1733 / 2389 (72.5%) | 6060 / 12362 (49.0%) | <0.001 |
| Cerebrovascular disease | 500 / 2389 (20.9%) | 2009 / 12360 (16.3%) | <0.001 |
| Peripheral arterial disease | 425 / 2389 (17.8%) | 2375 / 12361 (19.2%) | 0.104 |
| Prior MI | 1258 / 2389 (52.7%) | 3420 / 12362 (27.7%) | <0.001 |
| NYHA class | |||
| I | 738 / 2387 (30.9%) | - | |
| II | 1333 / 2387 (55.8%) | - | |
| III | 303 / 2387 (12.7%) | - | |
| IV | 13 / 2387 (0.5%) | - | |
| Most recent assessment of left ventricular function (ejection fraction) | |||
| Normal (>55%) | 516 / 2389 (21.6%) | 2409 / 12362 (19.5%) | |
| Mild Dysfunction (40–55%) | 574 / 2389 (24.0%) | 924 / 12362 (7.5%) | |
| Moderate Dysfunction (25–39%) | 247 / 2389 (10.3%) | 141 / 12362 (1.1%) | |
| Severe Dysfunction (<25%) | 56 / 2389 (2.3%) | 25 / 12362 (0.2%) | |
| Unknown | 996 / 2389 (41.7%) | 8863 / 12362 (71.7%) | |
| Duration of type 2 diabetes (years) | 0.051 | ||
| Median (Q1, Q3) | 12.0 (7.0, 18.0) | 12.0 (7.0, 18.0) | |
| Antihyperglycemic agents therapy | |||
| None | 25 / 2389 (1.0%) | 203 / 12362 (1.6%) | 0.031 |
| Oral agents use | 1904 / 2389 (79.7%) | 10587 / 12362 (85.6%) | <0.001 |
| Insulin use | 1222 / 2389 (51.2%) | 5613 / 12362 (45.4%) | <0.001 |
| DPP-4 inhibitor therapy | 280 / 2389 (11.7%) | 1923 / 12362 (15.6%) | <0.001 |
| Biguanides | 1681 / 2389 (70.4%) | 9614 / 12362 (77.8%) | <0.001 |
| SGLT-2 inhibitors‡ | 4/1334 (0.3%) | 73/7205 (1.0%) | 0.011 |
| A1c (%) | <0.001 | ||
| Median (Q1, Q3) | 8.1 (7.4, 9.0) | 8.0 (7.3, 8.8) | |
| Body mass index (kg/m2) | <0.001 | ||
| Median (Q1, Q3) | 32.9 (29.3, 37.4) | 31.6 (28.1, 35.9) | |
| eGFR (mL/min/1.73 m2)** | <0.001 | ||
| Median (Q1, Q3) | 70.4 (56.6, 88.2) | 77.2 (62.4, 92.9) | |
Total cohort of 14,752. One patient’s history of heart failure status was missing.
*
Age = ((date of randomization - date of birth) + 1) / 365.25 rounded down to the nearest whole year.
‡
Information regarding SGLT-2 inhibitor use and ‘other antihyperglycemic agent’ use was added to the electronic case report form on May 9, 2013.
**
MDRD formula was used to calculate the eGFR. Site-reported values are presented in the table.
A1c, glycated hemoglobin; CV, cardiovascular; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; MI, myocardial infarction; NYHA, New York Heart Association; Q1, Q3, interquartile range; SGLT-2, sodium-glucose co-transporter 2.