Table 1.

Key baseline demographic and medical history characteristics by occurrence of calcific uremic arteriolopathy adverse event during the study (safety analysis set)

CharacteristicCUA (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 yr16 (88.9)6 (100)22 (91.7)1435 (75.3)1403 (72.6)2838 (74.0)
  ≥65 yr2 (11.1)0 (0.0)2 (8.3)470 (24.7)529 (27.4)999 (26.0)
Race group, n (%)0.28
 White11 (61.1)4 (66.7)15 (62.5)1100 (57.7)1115 (57.7)2215 (57.7)
 Black6 (33.3)1 (16.7)7 (29.2)417 (21.9)404 (20.9)821 (21.4)
 Other1 (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)
 Systolic163.0 (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
 Diastolic85.0 (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
 Never6 (33.3)3 (50.0)9 (37.5)1081 (56.7)1077 (55.7)2158 (56.2)
 Current3 (16.7)1 (16.7)4 (16.7)317 (16.6)310 (16.0)627 (16.3)
 Former9 (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 10 (0.0)0 (0.0)0 (0.0)81 (4.3)73 (3.8)154 (4.0)0.32
 Type 211 (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
 Hypertension18 (100)6 (100)24 (100)1746 (91.7)1786 (92.4)3532 (92.1)0.15
 Heart failure9 (50.0)2 (33.3)11 (45.8)443 (23.3)444 (23.0)887 (23.1)<0.01
 Peripheral vascular disease8 (44.4)0 (0.0)8 (33.3)313 (16.4)313 (16.2)626 (16.3)0.03
 CABG1 (5.6)2 (33.3)3 (12.5)152 (8.0)133 (6.9)285 (7.4)0.35
 PCI1 (5.6)0 (0.0)1 (4.2)130 (6.8)130 (6.7)260 (6.8)0.61
 Myocardial infarction1 (5.6)0 (0.0)1 (4.2)242 (12.7)238 (12.3)480 (12.5)0.22
 Stroke1 (5.6)1 (16.7)2 (8.3)192 (10.1)160 (8.3)352 (9.2)0.89
 Transient ischemic attack1 (5.6)0 (0.0)1 (4.2)73 (3.8)98 (5.1)171 (4.5)0.95
 Amputation2 (11.1)0 (0.0)2 (8.3)127 (6.7)121 (6.3)248 (6.5)0.71
 Atrial fibrillation4 (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.