Table 2.
OA pain intensity
| Lumiracoxib 100 mg od (n = 811) |
Lumiracoxib 100 mg od with initial dose (n = 805) |
Celecoxib 200 mg od (n = 813) |
Placebo (n = 806) |
|
| Mean change from baseline at week 2 ± SDa | -20.1b ± 21.97 | -20.9b ± 22.50 | -20.2b ± 21.86 | -12.1 ± 19.92 |
| Mean change from baseline at week 13 ± SDa | -26.0b ± 24.83 | -26.0b ± 24.92 | -25.4b ± 25.03 | -19.8 ± 24.75 |
| Response by MCIIa | ||||
| Responders at week 2, n (%) | 383 (47.2) | 378 (47.0) | 392 (48.3) | 254 (31.6) |
| Odds ratio versus placeboc (95% CI) | 1.94b (1.58–2.38) | 1.92b (1.57–2.35) | 2.02b (1.65–2.48) | NA |
| Odds ratio versus celecoxibc (95% CI) | 0.96d (0.79–1.17) | 0.95d (0.78–1.15) | NA | NA |
| Responders at week 13, n (%) | 484 (59.7) | 489 (60.7) | 463 (57.0) | 393 (48.8) |
| Odds ratio versus placeboc (95% CI) | 1.55b (1.27–1.89) | 1.62b (1.33–1.98) | 1.39b (1.14–1.69) | NA |
| Odds ratio versus celecoxibc (95% CI) | 1.12d (0.92–1.36) | 1.17d (0.96–1.42) | NA | NA |
| Patients considering their current state as satisfactory by PASSe | ||||
| Satisfied patients at week 2, n (%) | 251 (30.9) | 270 (33.5) | 242 (29.8) | 137 (17.0) |
| Odds ratio versus placeboc (95% CI) | 2.19b (1.73–2.77) | 2.46b (1.95–3.12) | 2.07b (1.63–2.62) | NA |
| Odds ratio versus celecoxibc (95% CI) | 1.06d (0.86–1.31) | 1.19d (0.97–1.47) | NA | NA |
| Satisfied patients at week 13, n (%) | 351 (43.3) | 365 (45.3) | 343 (42.2) | 286 (35.5) |
| Odds ratio versus placeboc (95% CI) | 1.39b (1.14–1.70) | 1.51b (1.23–1.84) | 1.33f (1.09–1.62) | NA |
| Odds ratio versus celecoxibc (95% CI) | 1.05d (0.86–1.27) | 1.14d (0.93–1.38) | NA | NA |
aA patient was considered a responder by MCII if his/her change from baseline for OA pain intensity was decreased by greater than or equal to 19.9 mm. bp < 0.001 versus placebo. cMultiple logistic regression model with treatment as main effect. Pairwise comparisons were tested using two-sided significance unadjusted for multiple comparisons. dp value non-significant. eA patient was considered as achieving a satisfactory state according to PASS if his/her value for OA pain intensity was less than or equal to 32.3 mm. fp < 0.01 versus placebo. CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; OA, osteoarthritis; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation.