Table 1.
Characteristics of All Included Patients
| No Cardiovascular Events (n=4626) | Cardiovascular Events (n=899) | P Value | |
|---|---|---|---|
| Randomized to lixisenatide | 2327 (50.3%) | 449 (49.9%) | 0.84 |
| Age, y | 59.7±9.5 | 63.3±9.7 | <0.001 |
| Male (%) | 3238 (70.0%) | 627 (69.7%) | 0.88 |
| BMI, kg/m2 | 30.0±5.6 | 30.3±6.1 | 0.24 |
| Race | <0.001 | ||
| Asian | 648 (14.0%) | 82 (9.1%) | |
| Black | 14 (3.1%) | 47 (5.2%) | |
| Other | 385 (8.3%) | 86 (9.6%) | |
| White | 3451 (74.6%) | 684 (76.1%) | |
| Ethnicity—Hispanic | 1396 (30.2%) | 250 (27.8%) | 0.16 |
| Region | <0.001 | ||
| Africa/Near East | 215 (4.6%) | 54 (6.0%) | |
| Asia Pacific | 597 (12.9%) | 72 (8.0%) | |
| Eastern Europe | 1172 (25.3%) | 241 (26.8%) | |
| North America | 563 (12.2%) | 153 (17.0%) | |
| South and Centr. America | 1551 (33.5%) | 273 (30.4%) | |
| Western Europe | 528 (11.4%) | 106 (11.8%) | |
| Systolic blood pressure, mm Hg | 129±17 | 131±19 | 0.86 |
| Diastolic blood pressure, mm Hg | 77±10 | 77±11 | 0.18 |
| Heart rate, bpm | 70±10 | 71±11 | 0.001 |
| Current smoker | 511 (11.0%) | 117 (13.0%) | 0.09 |
| Former smoker | 2113 (45.7%) | 409 (45.5%) | 0.92 |
| Medical history | |||
| MI | 918 (19.8%) | 340 (37.7%) | <0.001 |
| HF | 905 (19.5%) | 330 (36.7%) | <0.001 |
| Atrial fibrillation/flutter | 240 (5.2%) | 121 (13.5%) | <0.001 |
| PAD | 271 (5.9%) | 142 (15.8%) | <0.001 |
| TIA | 83 (1.8%) | 44 (4.9%) | <0.001 |
| Ventricular tachycardia | 57 (1.2%) | 17 (1.9%) | 0.12 |
| Stroke | 201 (4.3%) | 91 (10.1%) | <0.001 |
| CABG | 309 (6.7%) | 151 (16.8%) | <0.001 |
| Implanted pacemaker | 102 (2.2%) | 41 (4.6%) | <0.001 |
| Carotid disease | 87 (1.9%) | 52 (5.8%) | <0.001 |
| Hypertension | 3449 (74.6%) | 761 (84.6%) | <0.001 |
| Index event | <0.001 | ||
| STEMI | 2146 (46.4%) | 297 (33.0%) | |
| NSTEMI | 1702 (36.8%) | 432 (48.1%) | |
| Unstable angina pectoris | 778 (16.8%) | 170 (18.9%) | |
| PCI at index event | 2943 (63.6%) | 463 (51.5%) | <0.001 |
| Insulin‐treated | 1699 (36.7%) | 460 (51.2%) | <0.001 |
| Duration of diabetes mellitus, y | 8.8±7.9 | 11.9±9.5 | <0.001 |
| Retinopathy | 452 (9.8%) | 139 (15.5%) | <0.001 |
| Neuropathy | 714 (15.4%) | 205 (22.8%) | <0.001 |
| Asthma | 114 (2.5%) | 40 (4.4%) | <0.001 |
| COPD | 173 (3.7%) | 76 (8.5%) | <0.001 |
| HbA1c, % | 7.6±1.3 | 7.9±1.3 | <0.001 |
| HDL, mg/dL | 43±11 | 43±11 | 0.65 |
| LDL, mg/dL | 77±34 | 83±39 | <0.001 |
| eGFR, mL/min per 1.73 m2 | 77.5±21.1 | 68.1±20.6 | <0.001 |
| Albuminuria | <0.001 | ||
| Normoalbuminuria | 3558 (76.9%) | 544 (60.5%) | |
| Microalbuminuria | 829 (17.9%) | 234 (26.0%) | |
| Macroalbuminuria | 239 (5.2%) | 121 (13.5%) | |
| Hemoglobin, g/dL | 13.8±1.4 | 13.5±1.5 | <0.001 |
| Na, mmol/L | 140.4±2.9 | 140.3±3.1 | 0.75 |
| Albumin, g/dL | 4.1±0.3 | 3.9±0.4 | <0.001 |
| CRP, mg/dL | 2.0 (1.9–2.0) | 2.7 (2.4–2.9) | <0.001 |
| BNP, pg/mL | 95 (92–98) | 198 (184–213) | <0.001 |
| NT‐proBNP, pg/mL | 285 (274–295) | 703 (644–766) | <0.001 |
BMI indicates body mass index; bpm, beats per minute; BNP, B‐type natriuretic peptide; CABG, coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; CRP, C‐reactive protein; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; HDL, high‐density lipoproteins; HF, heart failure; LDL, low‐density lipoproteins; MI, myocardial infarction; NSTEMI, non‐ST elevation myocardial infarction; NT‐proBNP, N‐terminal prohormone B‐type natriuretic peptide; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; STEMI, ST elevation myocardial infarction; TIA, transient ischemic attack.