Table 2.
Baseline characteristics by incidence of first heart failure event requiring hospitalization and treatment
| Heart Failure Event Requiring Hospitalization | No Heart Failure Events | |||
|---|---|---|---|---|
| Exenatide N=219 | Placebo N=231 | Exenatide N=7137 | Placebo N=7165 | |
| Age at randomization (years)* | ||||
| Median (Q1, Q3) | 66.0 (9.3) | 65.4 (8.3) | 61.7 (9.4) | 61.8 (9.4) |
| Sex | ||||
| Male | 155 / 219 (70.8%) | 164 / 231 (71.0%) | 4407 / 7137 (61.7%) | 4423 / 7165 (61.7%) |
| Ethnicity | ||||
| White | 190 / 219 (86.8%) | 193 / 231 (83.5%) | 5364 / 7135 (75.2%) | 5428 / 7162 (75.8%) |
| Black | 15 / 219 (6.8%) | 20 / 231 (8.7%) | 427 / 7135 (6.0%) | 416 / 7162 (5.8%) |
| Asian | 4 / 219 (1.8%) | 6 / 231 (2.6%) | 721 / 7135 (10.1%) | 721 / 7162 (10.1%) |
| Indian (American) or Alaska Native | 0 / 219 (0.0%) | 2 / 231 (0.9%) | 38 / 7135 (0.5%) | 33 / 7162 (0.5%) |
| Native Hawaiian or Other Pacific Islander | 0 / 219 (0.0%) | 0 / 231 (0.0%) | 18 / 7135 (0.3%) | 17 / 7162 (0.2%) |
| Hispanic | 10 / 219 (4.6%) | 10 / 231 (4.3%) | 567 / 7135 (7.9%) | 547 / 7162 (7.6%) |
| Region | ||||
| Europe | 84 / 219 (38.4%) | 99 / 231 (42.9%) | 3305 / 7137 (46.3%) | 3300 / 7165 (46.1%) |
| North America | 112 / 219 (51.1%) | 111 / 231 (48.1%) | 1722 / 7137 (24.1%) | 1763 / 7165 (24.6%) |
| Latin America | 12 / 219 (5.5%) | 12 / 231 (5.2%) | 1352 / 7137 (18.9%) | 1351 / 7165 (18.9%) |
| Asia Pacific | 11 / 219 (5.0%) | 9 / 231 (3.9%) | 758 / 7137 (10.6%) | 751 / 7165 (10.5%) |
| Coronary artery disease | 172 / 219 (78.5%) | 169 / 231 (73.2%) | 3726 / 7137 (52.2%) | 3727 / 7165 (52.0%) |
| Cerebrovascular disease | 52 / 219 (23.7%) | 52 / 231 (22.5%) | 1181 / 7135 (16.6%) | 1224 / 7165 (17.1%) |
| Peripheral arterial disease | 41 / 219 (18.7%) | 61 / 231 (26.4%) | 1359 / 7136 (19.0%) | 1339 / 7165 (18.7%) |
| Prior MI | 112 / 219 (51.1%) | 110 / 231 (47.6%) | 2236 / 7137 (31.3%) | 2221 / 7165 (31.0%) |
| NYHA class | ||||
| I | 21 / 89 (23.6%) | 21 / 87 (24.1%) | 344 / 1071 (32.1%) | 352 / 1140 (30.9%) |
| II | 42 / 89 (47.2%) | 53 / 87 (60.9%) | 586 / 1071 (54.7%) | 652 / 1140 (57.2%) |
| III | 24 / 89 (27.0%) | 10 / 87 (11.5%) | 138 / 1071 (12.9%) | 131 / 1140 (11.5%) |
| IV | 2 / 89 (2.2%) | 3 / 87 (3.4%) | 3 / 1071 (0.3%) | 5 / 1140 (0.4%) |
| Most recent assessment of left ventricular function (ejection fraction) | ||||
| Normal (>55%) | 37 / 219 (16.9%) | 51 / 231 (22.1%) | 1410 / 7137 (19.8%) | 1427 / 7165 (19.9%) |
| Mild Dysfunction (40–55%) | 37 / 219 (16.9%) | 48 / 231 (20.8%) | 706 / 7137 (9.9%) | 707 / 7165 (9.9%) |
| Moderate Dysfunction (25–39%) | 34 / 219 (15.5%) | 18 / 231 (7.8%) | 176 / 7137 (2.5%) | 160 / 7165 (2.2%) |
| Severe Dysfunction (<25%) | 15 / 219 (6.8%) | 9 / 231 (3.9%) | 27 / 7137 (0.4%) | 30 / 7165 (0.4%) |
| Unknown | 96 / 219 (43.8%) | 105 / 231 (45.5%) | 4818 / 7137 (67.5%) | 4841 / 7165 (67.6%) |
| Duration of type 2 diabetes (years) | ||||
| Median (Q1, Q3) | 14.0 (8.0, 21.0) | 15.0 (9.0, 22.0) | 12.0 (7.0, 17.0) | 12.0 (7.0, 18.0) |
| Antihyperglycemic therapy | ||||
| None | 3 / 219 (1.4%) | 4 / 231 (1.7%) | 104 / 7137 (1.5%) | 117 / 7165 (1.6%) |
| Oral agents use | 148 / 219 (67.6%) | 165 / 231 (71.4%) | 6065 / 7137 (85.0%) | 6113 / 7165 (85.3%) |
| Insulin use | 140 / 219 (63.9%) | 152 / 231 (65.8%) | 3257 / 7137 (45.6%) | 3287 / 7165 (45.9%) |
| DPP-4 inhibitor therapy | 27 / 219 (12.3%) | 24 / 231 (10.4%) | 1091 / 7137 (15.3%) | 1061 / 7165 (14.8%) |
| Biguanides | 125 / 219 (57.1%) | 138 / 231 (59.7%) | 5493 / 7137 (77.0%) | 5539 / 7165 (77.3%) |
| Insulin use, alone or in combination | 140 / 219 (63.9%) | 152 / 231 (65.8%) | 3257 / 7137 (45.6%) | 3287 / 7165 (45.9%) |
| A1c (%) | ||||
| Median (Q1, Q3) | 62.8 (57.4, 73.8) | 65.0 (56.6, 73.8) | 63.9 (56.3, 73.8) | 63.9 (56.3, 73.8) |
| Body mass index (kg/m2) | ||||
| Median (Q1, Q3) | 34.6 (30.7, 39.4) | 35.2 (31.0, 40.9) | 31.8 (28.1, 36.1) | 31.6 (28.2, 36.0) |
| eGFR group (mL/min/1.73 m2)** | ||||
| eGFR ≥60 | 122 / 216 (56.5%) | 142 / 231 (61.5%) | 5647 / 7118 (79.3%) | 5603 / 7140 (78.5%) |
| eGFR <60 | 94 / 216 (43.5%) | 89 / 231 (38.5%) | 1471 / 7118 (20.7%) | 1537 / 7140 (21.5%) |
*
Age = ((date of randomization - date of birth) + 1) / 365.25 rounded down to the nearest whole year.
**
MDRD formula was used to calculate the eGFR. Site reported values are presented in the table.
A1c, glycated hemoglobin; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; MI, myocardial infarction; NYHA, New York Heart Association.