Table 1.
Key baseline demographic and medical history characteristics by occurrence of calcific uremic arteriolopathy adverse event during the study (safety analysis set)
| Characteristic | CUA (n=24) | No CUA (n=3837) | P Valuea | ||||
|---|---|---|---|---|---|---|---|
| Placebo (N1=18) | Cinacalcet (N1=6) | Total (N1=24) | Placebo (N1=1905) | Cinacalcet (N1=1932) | Total (N1=3837) | ||
| Median age (10%, 90% percentile) (yr) | 54.5 (43.0, 71.0) | 59.5 (32.0, 63.0) | 56.0 (43.0, 63.0) | 54.0 (35.0, 73.0) | 55.0 (35.0, 74.0) | 55.0 (35.0, 73.0) | 0.99 |
| Age category, n (%) | 0.05 | ||||||
| <65 yr | 16 (88.9) | 6 (100) | 22 (91.7) | 1435 (75.3) | 1403 (72.6) | 2838 (74.0) | |
| ≥65 yr | 2 (11.1) | 0 (0.0) | 2 (8.3) | 470 (24.7) | 529 (27.4) | 999 (26.0) | |
| Race group, n (%) | 0.28 | ||||||
| White | 11 (61.1) | 4 (66.7) | 15 (62.5) | 1100 (57.7) | 1115 (57.7) | 2215 (57.7) | |
| Black | 6 (33.3) | 1 (16.7) | 7 (29.2) | 417 (21.9) | 404 (20.9) | 821 (21.4) | |
| Other | 1 (5.6) | 1 (16.7) | 2 (8.3) | 388 (20.4) | 413 (21.4) | 801 (20.9) | |
| Women, n (%) | 11 (61.1) | 4 (66.7) | 15 (62.5) | 754 (39.6) | 802 (41.5) | 1556 (40.6) | 0.03 |
| Median BMI (10%, 90% percentile) (kg/m2) | 34.4 (24.7, 43.5) | 28.5 (21.3, 37.3) | 34.1 (23.1, 41.8) | 26.3 (20.6, 36.6) | 26.3 (20.4, 36.4) | 26.3 (20.5, 36.5) | <0.001 |
| BP (10%, 90% percentile) (mmHg) | |||||||
| Systolic | 163.0 (120.0, 184.0) | 153.5 (137.0, 209.0) | 162.5 (137.0, 184.0) | 140.0 (110.0, 177.0) | 140.0 (110.0, 176.0) | 140.0 (110.0, 176.0) | <0.001 |
| Diastolic | 85.0 (67.0, 100.0) | 80.0 (72.0, 130.0) | 83.0 (70.0, 100.0) | 80.0 (60.0, 100.0) | 80.0 (60.0, 100.0) | 80.0 (60.0, 100.0) | 0.02 |
| Tobacco use, n (%) | 0.11 | ||||||
| Never | 6 (33.3) | 3 (50.0) | 9 (37.5) | 1081 (56.7) | 1077 (55.7) | 2158 (56.2) | |
| Current | 3 (16.7) | 1 (16.7) | 4 (16.7) | 317 (16.6) | 310 (16.0) | 627 (16.3) | |
| Former | 9 (50.0) | 2 (33.3) | 11 (45.8) | 506 (26.6) | 545 (28.2) | 1051 (27.4) | |
| History of diabetes, n (%) | 11 (61.1) | 2 (33.3) | 13 (54.2) | 633 (33.2) | 650 (33.6) | 1283 (33.4) | 0.03 |
| Type 1 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 81 (4.3) | 73 (3.8) | 154 (4.0) | 0.32 |
| Type 2 | 11 (61.1) | 2 (33.3) | 13 (54.2) | 553 (29.0) | 577 (29.9) | 1130 (29.5) | <0.01 |
| History of cardiovascular disease, n (%) | 18 (100) | 6 (100) | 24 (100) | 1801 (94.5) | 1842 (95.3) | 3643 (94.9) | 0.26 |
| Hypertension | 18 (100) | 6 (100) | 24 (100) | 1746 (91.7) | 1786 (92.4) | 3532 (92.1) | 0.15 |
| Heart failure | 9 (50.0) | 2 (33.3) | 11 (45.8) | 443 (23.3) | 444 (23.0) | 887 (23.1) | <0.01 |
| Peripheral vascular disease | 8 (44.4) | 0 (0.0) | 8 (33.3) | 313 (16.4) | 313 (16.2) | 626 (16.3) | 0.03 |
| CABG | 1 (5.6) | 2 (33.3) | 3 (12.5) | 152 (8.0) | 133 (6.9) | 285 (7.4) | 0.35 |
| PCI | 1 (5.6) | 0 (0.0) | 1 (4.2) | 130 (6.8) | 130 (6.7) | 260 (6.8) | 0.61 |
| Myocardial infarction | 1 (5.6) | 0 (0.0) | 1 (4.2) | 242 (12.7) | 238 (12.3) | 480 (12.5) | 0.22 |
| Stroke | 1 (5.6) | 1 (16.7) | 2 (8.3) | 192 (10.1) | 160 (8.3) | 352 (9.2) | 0.89 |
| Transient ischemic attack | 1 (5.6) | 0 (0.0) | 1 (4.2) | 73 (3.8) | 98 (5.1) | 171 (4.5) | 0.95 |
| Amputation | 2 (11.1) | 0 (0.0) | 2 (8.3) | 127 (6.7) | 121 (6.3) | 248 (6.5) | 0.71 |
| Atrial fibrillation | 4 (22.2) | 0 (0.0) | 4 (16.7) | 221 (11.6) | 202 (10.5) | 423 (11.0) | 0.38 |
| History of parathyroidectomy, n (%) | 3 (16.7) | 1 (16.7) | 4 (16.7) | 84 (4.4) | 90 (4.7) | 174 (4.5) | <0.01 |
| History of dyslipidemia, n (%) | 12 (66.7) | 3 (50.0) | 15 (62.5) | 744 (39.1) | 768 (39.8) | 1512 (39.4) | 0.02 |
N1 refers to number of patients in the safety analysis set; n percentages are based on N1. CUA, calcific uremic arteriolopathy; BMI, body mass index; CABG, coronary artery bypass grafting; PCI, percutaneous coronary intervention.
a
Wilcoxon rank sum test was used for continuous variables and chi-square test was used for categorical variables. Comparisons are between patients who experienced a CUA adverse event compared with those who did not.