Table 3.
Comparison of cardiovascular risk factors at baseline—all randomized patients (ITT population)
| Variable | All comparators (N = 2125) n (%) |
All dulaglutide (N = 3885) n (%) |
Total (N = 6010) n (%) |
p valuea |
|---|---|---|---|---|
| Prior MI | 51 (2.4) | 132 (3.4) | 183 (3.0) | 0.049 |
| History of unstable angina | 34 (1.6) | 55 (1.4) | 89 (1.5) | 0.632 |
| Prior coronary revascularization | 65 (3.1) | 115 (3.0) | 180 (3.0) | 0.738 |
| History of stroke or TIA | 35 (1.7) | 63 (1.6) | 98 (1.6) | 0.979 |
| History of heart failure | 12 (0.6) | 16 (0.4) | 28 (0.5) | 0.284 |
| History of (documented) coronary artery disease | 86 (4.1) | 189 (4.9) | 275 (4.6) | 0.163 |
| Has hypertension | 1357 (63.9) | 2451 (63.1) | 3808 (63.4) | 0.504 |
| Has hyperlipidemiab | 1176 (55.3) | 2116 (54.5) | 3292 (54.8) | 0.296 |
| History of carotid revascularizationc | 4 (0.2) | 8 (0.2) | 12 (0.2) | 0.863 |
| History of lower extremity arterial revascularizationc | 7 (0.5) | 8 (0.3) | 15 (0.3) | 0.380 |
| History of peripheral vascular diseasec | 30 (1.4) | 57 (1.5) | 87 (1.5) | 0.962 |
| History of atrial fibrillationc | 30 (1.4) | 38 (1.0) | 68 (1.1) | 0.173 |
| Current smoker | 335 (15.9) | 551 (14.3) | 886 (14.8) | 0.101 |
| Current smoker with hypertension and hyperlipidemia | 138 (6.5) | 217 (5.6) | 355 (5.9) | 0.161 |
| Kidney function group by eGFR | – | – | – | 0.899 |
| <30 mL/min/1.73 m2 | 1 (0.1) | 2 (0.1) | 3 (0.1) | |
| 30 ≤ eGFR < 60 mL/min/1.73 m2 | 126 (5.9) | 228 (5.9) | 354 (5.9) | |
| ≥60 mL/min/1.73 m2 | 1998 (94.0) | 3654 (94.1) | 5652 (94.1) | |
| Albuminuria group by urine ACRd | – | – | – | 0.433 |
| <30 mg/g | 1566 (76.8) | 2811 (77.1) | 4377 (77.0) | |
| 30 ≤ Urine ACR ≤ 300 mg/g | 395 (19.4) | 713 (19.6) | 1108 (19.5) | |
| >300 mg/g | 79 (3.9) | 121 (3.3) | 200 (3.5) |
eGFR estimated glomerular filtration rate, HDL high density lipoprotein, LDL low density lipoprotein, MI myocardial infarction, TIA transient ischemic attack, urine ACR urinary albumin/creatinine ratio
aTreatments were compared by Cochran–Mantel–Haenszel test. Strata = studies
bHaving hyperlipidemia or taking lipid lowering drugs at baseline or having LDL-C ≥160 mg/dL or HDL-C <40 mg/dL or triglycerides ≥200 mg/dL. Missing value was set to category ‘No’
cCV risk factors were either collected directly or were identified by searching historical events and pre-existing events at baseline with relevant preferred terms. Missing value is set to category ‘No’. History of lower extremity arterial revascularization was not collected, could not be defined, and is missing for the dose titration study, the monotherapy study, and AWARD-5 study
dUrine ACR was not collected in the dose titration study