Table 1.
Characteristics of the patients at baseline
| Characteristic | Celecoxib | nsNSAID |
|---|---|---|
| (N = 3647) | (N = 3650) | |
| Male sex, no. (%) | 1527 (41.9) | 1432 (39.2) |
| Current smoker, no. (%) | 547 (15.0) | 583 (16.0) |
| Ethnic group (White), no. (%) | 3638 (99.8) | 3636 (99.6) |
| Age, years | 68.6 ± 6.2 | 68.2 ± 6.1 |
| Systolic blood pressurea, mmHg | 140.5 ± 17.8 | 140.8 ± 17.9 |
| Diastolic blood pressurea, mmHg | 77.6 ± 10.7 | 77.7 ± 10.7 |
| Heart ratea beats/min | 70.8 ± 11.3 | 70.4 ± 11.1 |
| Body-mass indexb,c | 29.6 ± 5.7 | 29.8 ± 5.6 |
| Waist/Hip ratiod,e | 0.91 ± 0.1 | 0.91 ± 0.1 |
| Histories of, no. (%) | ||
| Heart failure (NYHA I/II) | 4 (0.1) | 10 (0.3) |
| Diabetes | 301 (8.3) | 285 (7.8) |
| High blood pressure | 1634 (44.8) | 1607 (44.0) |
| Raised cholesterol | 1268 (34.8) | 1211 (33.2) |
| Renal disease | 133 (3.6) | 125 (3.4) |
| Peptic ulcer | 254 (7.0) | 239 (6.5) |
| Upper GI hospitalization | 168 (4.6) | 180 (4.9) |
| Upper GI surgery | 88 (2.4) | 96 (2.6) |
| Gout | 305 (8.4) | 300 (8.2) |
| Helicobacter pylori eradication | 170 (4.7) | 154 (4.2) |
| Asthma | 365 (10.0) | 362 (9.9) |
| Chronic obstructive pulmonary disease | 158 (4.3) | 159 (4.4) |
| Randomization strataf, no. (%) | ||
| Arthritis indication—Osteoarthritis | 3421 (93.8) | 3422 (93.8) |
| NSAID strata (Ibuprofen) | 1149 (31.5) | 1153 (31.6) |
| NSAID strata (Diclofenac) | 1413 (38.7) | 1412 (38.7) |
| Baseline medication, no. (%) | ||
| Statins | 774 (21.1) | 748 (20.5) |
| Aspirin | 421 (11.5) | 433 (11.9) |
| Ulcer healing drug | 1401 (38.4) | 1357 (37.2) |
| Total cholesterolg, mg/dL | 202.3 ± 42.5 | 203.4 ± 42.5 |
| HDL cholesterolg, mg/dL | 55.6 ± 15.4 | 55.6 ± 15.4 |
| Triglyceridesh (IQR), mg/dL | 143.4 (104.4–204.4) | 145.1 (105.3–206.2) |
| Uric acidi, mg/dL | 5.5 ± 1.5 | 5.5 ± 1.5 |
Values are mean ± SD. There were no statistically significant differences between the two groups except for age (P = 0.006) and sex (P = 0.02), with values not adjusted for multiple testing. Percentages may not total 100 because of rounding.
IQR, denotes interquartile range.
aData on systolic blood pressure, diastolic blood pressure, and heart rate were not available for one participant in the celecoxib group and three participants in the nsNSAID group.
bData on body-mass index were not available for two participants in the celecoxib group and one participant in the nsNSAID group.
cThe body-mass index is the weight in kilograms divided by the square of the height in meters.
dData on waist/hip ratio were not available for four participants in the celecoxib group and one participant in the nsNSAID group.
eThe waist/hip ratio is the waist circumference in centimetres divided by the hip circumference in centimetres.
fNo P-values were calculated for the arthritis indication or NSAID strata as randomization was stratified according to these factors.
gData on total cholesterol and HDL cholesterol were not available for 386 participants in the celecoxib group and 385 participants in the nsNSAID group.
hData on triglycerides were not available for 385 participants in the celecoxib group and 385 participants in the nsNSAID group.
iData on uric acid were not available for 323 participants in the celecoxib group and 323 participants in the nsNSAID group.