Baseline patient characteristics
. | 6-wk base study . | . | 6-mo extension study . | . | ||
|---|---|---|---|---|---|---|
| Characteristic . | Placebo . | Etoricoxib 90 mg . | Rofecoxib 25 mg . | Etoricoxib 90 mg . | ||
| No. of patients | 51 | 51 | 19 | 74 | ||
| Age, y | ||||||
| Mean (SD) | 35.3 (13.2) | 33.9 (13.5) | 31.3 (10.79) | 35.3 (13.6) | ||
| Range* | 12-60 | 14-71 | 12-47 | 12-71 | ||
| Race, no. (%) | ||||||
| Hispanic American | 11 (21.6) | 8 (15.7) | 4 (21.1) | 14 (18.9) | ||
| Multiracial | 15 (29.4) | 20 (39.2) | 6 (31.6) | 28 (37.8) | ||
| White | 24 (47.1) | 22 (43.1) | 8 (42.1) | 31 (41.9) | ||
| Other | 1 (2.0) | 1 (2.0) | 1 (5.3) | 1 (1.4) | ||
| Body weight, kg | ||||||
| Mean (SD) | 68.76 (14.59) | 68.97 (15.94) | 68.1 (15.8) | 68.5 (14.5) | ||
| Range | 39.30-95.00 | 42.10-101.90 | 40.8-92.3 | 42.1-101.9 | ||
| Degree of hemophilia†, no. (%) | ||||||
| Mild | 5 (9.8) | 0 (0.0) | 0 (0.0) | 5 (6.8) | ||
| Moderate | 13 (25.5) | 16 (31.4) | 8 (42.1) | 17 (23.0) | ||
| Severe | 33 (64.7) | 35 (68.6) | 11 (57.9) | 52 (70.3) | ||
| History of ulcer or upper GI bleeding‡, no. (%) | 11 (21.6) | 9 (17.6) | 2 (15.8) | 12 (16.2) | ||
| Factor VIII deficiency, no. (%) | 44 (86.3) | 46 (90.2) | 17 (89.5) | 66 (89.2) | ||
| Factor IX deficiency, no. (%) | 7 (13.7) | 5 (9.8) | 2 (10.5) | 8 (10.8) | ||
| HIV as secondary diagnosis§, no. (%) | 13 (25.5) | 11 (21.6) | 5 (26.3) | 18 (24.3) | ||
| Hepatitis C as secondary diagnosis∥, no. (%) | 18 (35.3) | 22 (43.1) | 7 (36.8) | 30 (40.5) | ||
. | 6-wk base study . | . | 6-mo extension study . | . | ||
|---|---|---|---|---|---|---|
| Characteristic . | Placebo . | Etoricoxib 90 mg . | Rofecoxib 25 mg . | Etoricoxib 90 mg . | ||
| No. of patients | 51 | 51 | 19 | 74 | ||
| Age, y | ||||||
| Mean (SD) | 35.3 (13.2) | 33.9 (13.5) | 31.3 (10.79) | 35.3 (13.6) | ||
| Range* | 12-60 | 14-71 | 12-47 | 12-71 | ||
| Race, no. (%) | ||||||
| Hispanic American | 11 (21.6) | 8 (15.7) | 4 (21.1) | 14 (18.9) | ||
| Multiracial | 15 (29.4) | 20 (39.2) | 6 (31.6) | 28 (37.8) | ||
| White | 24 (47.1) | 22 (43.1) | 8 (42.1) | 31 (41.9) | ||
| Other | 1 (2.0) | 1 (2.0) | 1 (5.3) | 1 (1.4) | ||
| Body weight, kg | ||||||
| Mean (SD) | 68.76 (14.59) | 68.97 (15.94) | 68.1 (15.8) | 68.5 (14.5) | ||
| Range | 39.30-95.00 | 42.10-101.90 | 40.8-92.3 | 42.1-101.9 | ||
| Degree of hemophilia†, no. (%) | ||||||
| Mild | 5 (9.8) | 0 (0.0) | 0 (0.0) | 5 (6.8) | ||
| Moderate | 13 (25.5) | 16 (31.4) | 8 (42.1) | 17 (23.0) | ||
| Severe | 33 (64.7) | 35 (68.6) | 11 (57.9) | 52 (70.3) | ||
| History of ulcer or upper GI bleeding‡, no. (%) | 11 (21.6) | 9 (17.6) | 2 (15.8) | 12 (16.2) | ||
| Factor VIII deficiency, no. (%) | 44 (86.3) | 46 (90.2) | 17 (89.5) | 66 (89.2) | ||
| Factor IX deficiency, no. (%) | 7 (13.7) | 5 (9.8) | 2 (10.5) | 8 (10.8) | ||
| HIV as secondary diagnosis§, no. (%) | 13 (25.5) | 11 (21.6) | 5 (26.3) | 18 (24.3) | ||
| Hepatitis C as secondary diagnosis∥, no. (%) | 18 (35.3) | 22 (43.1) | 7 (36.8) | 30 (40.5) | ||
Six and 5 patients in the placebo group and etoricoxib group, respectively, were younger than 18 years of age
Mild is factor level > 5%; moderate, factor level 1% to 5%; severe, factor level < 1%
All patients with a history of an ulcer also had a history of upper GI bleeding
HIV serology was not evaluated as part of the study. The data are based on reported history
Patients had active disease at the time of randomization