Introduction
Methods
Study Populations
Results
Asiana
| Non-Asianb
|
P value | |||
---|---|---|---|---|---|
Celecoxib | Placebo | Celecoxib | Placebo | ||
n
| 145 | 78 | 152 | 66 | |
Gender, n (%) | 0.1177c
| ||||
Female | 97 (67) | 52 (67) | 88 (58) | 42 (64) | |
Male | 48 (33) | 26 (33) | 64 (42) | 24 (36) | |
Age, mean (SD), years | 65.9 (11.1) | 63.9 (11.1) | 58.4 (10.9) | 55.6 (10.4) | <0.0001d
|
Race, n (%) | <0.0001c
| ||||
Asian | 145 (100) | 78 (100) | 0 | 0 | |
White | 0 | 0 | 93 (61) | 39 (59) | |
Black | 0 | 0 | 37 (24) | 16 (24) | |
Other | 0 | 0 | 22 (14) | 11 (17) | |
Weight, mean (SD), kg | 66.5 (13.3) | 65.6 (12.4) | 87.9 (19.3) | 89.0 (22.2) | <0.0001d
|
Height, mean (SD), cm | 158.6 (8.0) | 158.2 (7.5) | 168.9 (9.7) | 165.8 (10.7) | <0.0001d
|
BMI, mean (SD), kg/m2
| 26.4 (4.8) | 26.1 (4.2) | 30.7 (5.8) | 32.4 (7.5) | <0.0001d
|
Duration of OA, years | |||||
Mean (SD) | 4.5 (4.0) | 4.6 (4.3) | 6.5 (7.4) | 6.2 (8.1) | 0.0021d
|
Median | 3.0 | 3.2 | 3.1 | 4.0 |
Asiana
| Non-Asianb
| |||
---|---|---|---|---|
Celecoxib | Placebo | Celecoxib | Placebo | |
n
| 121 | 58 | 108 | 42 |
Baseline, mean (SE) | 65.1 (1.1) | 63.7 (1.5) | 68.4 (1.1) | 66.2 (2.0) |
Week 6, mean (SE) | 21.7 (1.9) | 25.6 (3.1) | 28.5 (2.2) | 34.9 (3.8) |
Change from baseline, LS mean (SE) | −41.4 (2.3) | −38.6 (3.2) | −40.3 (2.3) | −33.4 (3.5) |
Difference in LS mean vs. non-Asianc
| ||||
LS mean | −1.1 | −5.2 | – | – |
95% confidence interval | −7.7, 5.5 | −14.8, 4.4 | – | – |
P value | 0.7400 | 0.2870 | – | – |
Asiana
| Non-Asianb
| |||
---|---|---|---|---|
Celecoxib | Placebo | Celecoxib | Placebo | |
n
| 145 | 76 | 147 | 65 |
Number of AEs | 64 | 33 | 81 | 44 |
Patients with AEs, n (%) | 40 (27.6) | 22 (28.9) | 49 (33.3) | 26 (40.0) |
Patients with serious AEs, n (%) | 0 | 0 | 1 (0.7) | 0 |
Patients discontinued due to AEs, n (%) | 10 (6.9) | 3 (3.9) | 5 (3.4) | 5 (7.7) |
GI-related AEs, n (%) | ||||
Abdominal pain | 11 (7.6) | 3 (3.9) | 4 (2.7) | 3 (4.6) |
Dyspepsia | 2 (1.4) | 0 | 4 (2.7) | 1 (1.5) |
Constipation | 0 | 0 | 1 (0.7) | 1 (1.5) |
Diarrhea | 2 (1.4) | 0 | 1 (0.7) | 0 |
Nausea | 1 (0.7) | 1 (1.3) | 6 (4.1) | 0 |
CNS-related AEs, n (%) | ||||
Depression | 11 (7.6) | 11 (14.5) | 12 (8.2) | 9 (13.8) |
Dizziness | 0 | 1 (1.3) | 0 | 1 (1.5) |
Headache | 3 (2.1) | 0 | 6 (4.1) | 3 (4.6) |