Table 1.
Baseline demographics and clinical characteristics of patients receiving postoperative HPβCD-diclofenac
| Variable | Age group (years) | p valuea | ||
|---|---|---|---|---|
| < 65 (N = 878) | 65–74 (N = 282) | ≥75 (N = 129) | ||
| Mean (SD) age, years | 49.0 (10.8) | 69.1 (3.0) | 78.5 (2.8) | < 0.0001 |
| Mean (SD) weight, kg | 89.4 (21.8) | 88.9 (18.2) | 78.0 (17.4) | < 0.0001 |
| Female gender, n (%) | 607 (69.1) | 161 (57.1) | 82 (63.6) | 0.0009 |
| Race, n (%) | < 0.0001 | |||
| Asian | 7 (0.8) | 4 (1.4) | 1 (0.8) | |
| Black | 109 (12.4) | 12 (4.3) | 5 (3.9) | |
| White | 724 (82.5) | 261 (92.6) | 122 (94.6) | |
| Other | 38 (4.3) | 5 (1.8) | 1 (0.8) | |
| Renal impairmentb, n (%) | < 0.0001 | |||
| Not impaired | 852 (97.0) | 252 (89.4) | 112 (86.8) | |
| Mild | 19 (2.2) | 29 (10.3) | 16 (12.4) | |
| Moderate | 3 (0.3) | 1 (0.4) | 0 (0.0) | |
| Missing | 4 (0.5) | 0 (0.0) | 1 (0.8) | |
| Procedure type, n (%) | < 0.0001 | |||
| Abdominal/pelvic | 418 (47.6) | 38 (13.5) | 10 (7.8) | |
| Orthopedic | 458 (52.2) | 244 (86.5) | 119 (92.2) | |
| Other | 2 (0.2) | 0 (0.0) | 0 (0.0) | |
| Procedure duration, h | 0.3557 | |||
| Mean (SD) | 1.53 (1.01) | 1.59 (0.79) | 1.45 (0.61) | |
| Median (range) | 1.33 (0.17–12.5) | 1.34 (0.33–5.35) | 1.32 (0.17–3.63) | |
SD standard deviation
aComparison of the three age groups was via ANOVA for numerical variables and Cochran–Mantel–Haenszel test for categorical variables
bDefined by creatinine level at screening: not impaired (≤ 1.0 × upper limit of the normal range [ULN]); mild (> 1.0 to ≤ 1.5 × ULN); or moderate (> 1.5 × ULN)