Table 1.
Baseline demographics and clinical characteristics (safety analysis set*)
| Regadenoson (n = 334) | Placebo (n = 170) | P value | |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 184 (55.1) | 92 (54.1) | .85 |
| Female | 150 (44.9) | 78 (45.9) | |
| Ethnicity, n (%) | |||
| Non-Hispanic or Latino | 296 (88.6) | 147 (86.5) | .474 |
| Hispanic or Latino | 38 (11.4) | 23 (13.5) | |
| Race, n (%) | |||
| White | 254 (76.0) | 115 (67.6) | .085 |
| Black/African American | 68 (20.4) | 47 (27.6) | |
| Asian | 10 (3.0) | 6 (3.5) | |
| Other | 2 (0.6) | 2 (1.2) | |
| Age | |||
| Mean (SD) (years) | 66.4 (11.3) | 66.1 (10.9) | .727 |
| Age ≥65 years, n (%) | 193 (57.8) | 92 (54.1) | |
| Weight (kg) | |||
| Mean (SD) | 94.3 (24.6) | 89.9 (23.0) | .052 |
| Body mass index (kg/m2) | |||
| Mean (SD) | 33.1 (7.3) | 31.9 (7.2) | .083 |
| CKD, n (%)† | |||
| Stage 3 | 287 (85.9) | 145 (85.3) | .893 |
| Stage 4 | 47 (14.1) | 25 (14.7) | |
| CAD history and risk factors, n (%) | |||
| CAD‡ | 133 (39.8) | 76 (44.7) | .494 |
| Hypertension | 321 (96.1) | 161 (94.7) | .493 |
| Hypercholesterolemia‡ | 278 (83.2) | 145 (85.3) | .742 |
| Type 2 diabetes‡ | 187 (56.0) | 98 (57.6) | .405 |
| Obesity‡ (BMI > 30 kg/m2) | 218 (65.3) | 98 (57.6) | .054 |
| Smoking‡ (≥10 pack-years) | 139 (41.6) | 67 (39.4) | .697 |
* The safety analysis set includes all randomized subjects who received any amount of drug.
CAD, Coronary artery disease; CKD, chronic kidney disease; BMI, body mass index.
† Based on the National Kidney Foundation Practice Guidelines for Chronic Kidney Disease.21 Stage 3 CKD was not subcategorized as stage 3a (eGFR 45-59 mL/minute/1.73 m2) or stage 3b (eGFR 30-44 mL/minute/1.73 m2) CKD.
‡ Either ongoing or subject had a history of condition.