Table 3.
Secondary efficacy analyses in the ITT population
| Outcome | Diacerein (n = 183) | Celecoxib (n = 187) | P-value |
|---|---|---|---|
| WOMAC total score (0–240 cm) | |||
| Baseline | 135.5 (44.3) | 130.1 (38.0) | – |
| Day 182 | 94.5 (55.3) | 87.1 (56.6) | – |
| Change | −41.0 (53.1) | −42.9 (55.0) | 0.813a |
| WOMAC stiffness score (0–20 cm) | |||
| Baseline | 11.8 (4.2) | 11.7 (4.0) | – |
| Day 182 | 8.2 (5.0) | 7.7 (5.0) | – |
| Change | −3.6 (5.0) | −4.0 (5.3) | 0.477a |
| WOMAC function score (0–170 cm) | |||
| Baseline | 95.2 (33.7) | 91.6 (28.8) | – |
| Day 182 | 68.1 (40.3) | 62.3 (40.8) | – |
| Change | −27.2 (39.0) | −29.3 (39.8) | 0.714a |
| VAS pain score (0–10 cm) | |||
| Baseline | 6.6 (1.3) | 6.4 (1.3) | – |
| Day 182 | 4.2 (2.6) | 3.9 (2.6) | – |
| Change | −2.3 (2.6) | −2.5 (2.6) | 0.686a |
| OMERACT-OARSI responder at Day 182 – n (%) | 99 (55.6) | 97 (53.3) | 0.658b |
| Joint swelling and effusion at Day 182 – n (%) | 19 (10.7) | 23 (12.5) | 0.601b |
| Consumption of rescue medication (tablets per day; days 0–182) | 1.1 (1.8) | 0.9 (1.0) | 0.330a |
| Patient’s global assessment of disease activity (0–10 cm) | |||
| Baseline | 5.9 (1.9) | 5.8 (1.8) | – |
| Day 182 | 4.2 (2.5) | 3.8 (2.5) | – |
| Change | −1.8 (2.8) | −2.0 (3.0) | 0.592a |
| Investigator’s global assessment of disease activity (0–10 cm) | |||
| Baseline | 5.9 (1.3) | 5.9 (1.4) | – |
| Day 182 | 3.9 (2.4) | 3.2 (2.3) | – |
| Change | −2.0 (2.6) | −2.7 (2.6) | 0.011a |
| Patient’s global assessment of response to therapy at Day 182 (0–10) | 3.9 (2.6) | 3.6 (2.5) | 0.381a |
| Investigator’s global assessment of response to therapy at Day 182 (0–10) | 3.9 (2.5) | 3.4 (2.4) | 0.057a |
| Quality of life (SF-36) (0–100) | |||
| Physical component summary | |||
| Baseline | 34.7 (7.0) | 34.0 (6.4) | – |
| Day 182 | 37.2 (7.8) | 38.6 (8.3) | – |
| Change | 2.5 (6.7) | 4.6 (8.1) | 0.008a |
| Mental component summary | |||
| Baseline | 49.2 (10.1) | 49.4 (10.1) | – |
| Day 182 | 51.0 (8.8) | 49.7 (9.4) | – |
| Change | 1.6 (8.3) | −0.1 (8.9) | 0.042a |
Data are mean (s.d.) or as indicated.
a
For continuous variables, between-group comparisons were done using a Student’s t test or Mann–Whitney test.
b
Between-group comparisons using a χ2 test.
n: number of patients in the treatment group; ITT: intention-to-treat; OARSI: Osteoarthritis Research Society International; OMERACT: Outcome Measures in Rheumatology Clinical Trials; SF-36: 36-Item Short Form Health Survey; VAS: visual analogue scale; WOMAC: Western Ontario and McMaster Universities Ostoearthritis Index.