Table 3.
Primary efficacy endpoint parameters from pooled reanalysis of patient reported data from prospective, randomized, double-blind, parallel-group studies in adult patients with moderate to severe osteoarthritis of the knee treated with an oral combination therapy or the gold standard nonsteroidal anti-inflammatory drug [13]
| Intention-to-treat population | OEC (n = 348) | Diclofenac (n = 349) | Difference (OEC therapy/diclofenac) |
|---|---|---|---|
| LAFI | |||
| At baseline, mean (SD) | 12.6 (2.4) | 12.7 (2.4) | Not significant |
| At end of treatment, mean (SD) | 9.1 (3.9) | 9.1 (4.2) | Not significant |
| Absolute difference, mean (SD) | –3.5 (4.2) | –3.6 (4.3) | Not significant |
| Relative difference (%), mean (SD) | –27.8 (30.8) | –28.3 (32.1) | Not significant |
| Effect size (Cohen’s d)a | 0.9 | 0.88 | Not significant |
| Significance of LAFI at baseline vs. study end within treatment groups | < 0.001 | < 0.001 | |
| ≤ 7b at baseline, n (%) | 3 (0.9) | 4 (1.1) | Not significant |
| ≤ 7 at end of treatment, n (%) | 115 (33) | 117 (33.5) | Not significant |
| Difference in LAFI ≤ 7 at baseline vs. study end, absolute (relative), n (%) for each treatment | 112 (31) | 113 (32.1) | Not significant |
| Significance of the difference in LAFI ≤ 7 at baseline vs. study end within treatment groups | < 0.001 | < 0.001 | |
| Relief ≥ 30%, n (%) | 138 (39.7) | 143 (41) | Not significant |
| Relief ≥ 50%, n (%) | 82 (23.6) | 84 (24.1) | Not significant |
| Relief ≥ 3 points, n (%) | 185 (53.2) | 192 (55) | Not significant |
LAFI Lequesne Algofunctional index, OEC oral enzyme combination therapy, SD standard deviation
aThis Cohen’s d effect size is the standardized mean difference in LAFI for OEC vs. diclofenac
bA LAFI ≤ 7 indicates only minor/mild OA impairment