Table 1.
Baseline participant characteristics.
| OAI | Naproxen | p-Value | |
|---|---|---|---|
| (n = 1246) | (n = 53) | ||
| Gender, female—n (%) | 659 (52.9) | 33 (62.3) | 0.180 |
| Age—years | 64.0 (56.0; 71.0) | 63.0 (58.0; 66.0) | 0.158 |
| Body mass index—kg/m2 | 29.1 (26.2; 32.6) | 31.5 (27.5; 34.9) | 0.009 |
| Target knee—n (%) | (n = 1245) | 0.256 | |
| Right | 732 (58.8) | 27 (50.9) | |
| Left | 513 (41.2) | 26 (49.1) | |
| WOMAC | |||
| (n = 1245) | |||
| Pain score (0–20) | 3.0 (0.0; 6.0) | 10.8 (9.8; 12.6) | <0.0001 |
| (n = 1240) | |||
| Function score (0–68) | 7.0 (1.0; 18.2) | 35.4 (30.6; 46.0) | <0.0001 |
| (n = 1243) | |||
| Stiffness score (0–8) | 2.0 (0.0; 3.0) | 5.2 (3.8; 6.2) | <0.0001 |
| (n = 1238) | |||
| Total score (0–96) | 11.8 (3.0; 27.0) | 51.4 (44.9; 64.2) | <0.0001 |
| Kellgren–Lawrence grade—n (%) | (n = 1245) | ||
| 0 | 69 (5.6) | Not available | |
| 1 | 102 (8.2) | ||
| 2 | 375 (30.1) | ||
| 3 | 528 (42.4) | ||
| 4 | 171 (13.7) | ||
| Joint space width, mm | 3.1 (1.9; 3.7) | 3.7 (2.5; 4.2) | 0.003 |
| Cartilage volume at baseline, mm3 | |||
| Global knee | 11,843 (9867; 14,898) | 10,649 (9272; 12,628) | 0.024 |
| Lateral compartment | 6662 (5465; 8147) | 5811 (4891; 6931) | 0.003 |
| Medial compartment | 5266 (4222; 6761) | 4901 (4501; 5760) | 0.344 |
| Bone curvature, m−1 | |||
| Global knee | 27.1 (23.9; 30.1) | 28.0 (24.9; 31.3) | 0.306 |
| Lateral compartment | 29.9 (26.3; 33.0) | 30.0 (24.8; 34.6) | 0.974 |
| Medial compartment | 23.9 (20.3; 27.9) | 26.0 (21.3; 30.2) | 0.028 |
Data are from the Osteoarthritis Initiative (OAI) or the Naproxen arm of the Licofelone clinical trial cohorts [28]. Data are median (1st quartile; 3rd quartile) unless otherwise indicated. Continuous variables were compared using the Wilcoxon Mann–Whitney test and proportions using the Pearson Chi-Square test. p values < 0.050 (in bold) were considered statistically different. n, number of participants; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.