TABLE 1.
Patient characteristics at screening
| Nonrandomized patients n = 1235 | P‐value | |||
|---|---|---|---|---|
| Characteristics | Pseudo‐ RHTa n = 872 | Non‐pseudo‐RHTa n = 363 | Randomized patients, n = 730 | Pseudo‐RHTa versus randomized |
| Age (years) | 62.2 ± 11.8 | 63.0 ± 12.5 | 61.7 ± 10.6 | .0541 |
| 18 ‐ < 65 | 463 (53.1) | 182 (50.1) | 409 (56.0) | |
| 65 ‐ < 75 | 290 (33.3) | 118 (32.5) | 249 (34.1) | |
| ≥75 | 119 (13.6) | 63 (17.4) | 72 (9.9) | |
| Sex | .8010 | |||
| Men | 513 (58.8) | 211 (58.1) b | 434 (59.5) | |
| Geographic area | <.0001 | |||
| Europe | 429 (49.2) | 146 (40.2) | 448 (61.4) | |
| North America | 316 (36.2) | 187 (51.5) | 232 (31.8) | |
| Asia/Australia | 127 (14.6) | 30 (8.3) | 50 (6.8) | |
| Race | <.0001 | |||
| White | 637 (73.1) | 250 (68.9) | 605 (82.9) | |
| Black/African American | 129 (14.8) | 81 (22.3) | 82 (11.2) | |
| Asian | 87 (10.0) | 22 (6.1) | 38 (5.2) | |
| Other or not reported | 19 (2.2) | 8 (2.2) | 5 (.7) | |
| Missing c | – | 2 (.6) | – | |
| BMI (kg/m2) | 32.2 ± 6.4 | 32.3 ± 6.9 | 33.7 ± 6.2 | .0001 |
| Low to overweight (< 30) | 315 (36.1) | 139 (38.3) | 225 (30.8) | |
| Obese (30‐ < 40) | 387 (44.4) | 157 (43.3) | 399 (54.7) | |
| Severely obese (≥40) | 85 (9.7) | 40 (11.0) | 106 (14.5) | |
| Missing c | 85 (9.7) | 27 (7.4) | – | |
| eGFR (ml/min/ 1.73 m2) | 74.8 ± 21.6 | 65.9 ± 26.1 | 76.4 ± 21.9 | .9188 |
| CKD stage 1–2 (≥60) | 541 (62.0) | 195 (53.7) | 568 (77.8) | |
| CKD stage 3a (45‐59) | 97 (11.1) | 56 (15.4) | 93 (12.7) | |
| CKD stage 3b‐4 (15‐44) | 65 (7.5) | 69 (19.0) | 69 (9.5) | |
| CKD stage 5 (< 15) | 1 (.1) | 4 (1.1) | – | |
| Missing c | 168 (19.3) | 39 (10.7) | – | |
| Medical history | ||||
| Diabetes mellitus | 372 (42.7) | 184 (50.7) | 389 (53.3) | <.0001 |
| Ischemic Heart Disease | 217 (24.9) | 123 (33.9) | 222 (30.4) | .0135 |
| Stroke | 140 (16.1) | 65 (17.9) | 167 (22.9) | .0006 |
| Congestive heart failure | 101 (11.6) | 66 (18.2) | 137 (18.8) | <.0001 |
| Sleep apnea syndrome | 114 (13.1) | 46 (12.7) | 103 (14.1) | .5461 |
Values are means (standard deviation) for continuous variables; n (%) for categorical variables.
aPatients with pseudo‐RHT did not meet the SiSBP ≥ 140 mm Hg inclusion criteria at screening, at switch to standardized background therapy, at run‐in entry, or at randomization. Patients with non‐pseudo‐RHT failed inclusion for a reason other than SiSBP < 140 mm Hg.
b
Missing in one non‐pseudo‐RHT patient.
c
Nonrandomized patients meeting the SiSBP exclusion criterion at screening may have an incomplete set of assessments.
Abbreviations: BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; RHT, resistant hypertension; SiSBP, sitting systolic blood pressure.