TABLE 1.
Association of biomarkers with demographic characteristics and CRC risk factors
| Characteristic | Strata | 15-PGDH absent (N=1156; 89.2%) | 15-PGDH present (N=139; 10.8%) | p-value | Cox-2 high (N=106; 8.2%) | Cox-2 low (N=1189; 91.8%) | p-value |
|---|---|---|---|---|---|---|---|
| Age (years) | 0.34 | 0.06 | |||||
| <65 | 786 (68%) | 100 (72%) | 64 (60%) | 822 (69%) | |||
| ≥65 | 370 (32%) | 39 (28%) | 42 (40%) | 367 (31%) | |||
| Gender | 0.87 | 0.81 | |||||
| Female | 358 (31%) | 44 (32%) | 34 (32%) | 368 (31%) | |||
| Male | 798 (69%) | 95 (68%) | 72 (68%) | 821 (69%) | |||
| Race | 0.96 | 0.99 | |||||
| Caucasian | 1080 (93%) | 130 (94%) | 99 (93%) | 1111 (93%) | |||
| Other | 76 (7%) | 9 (6%) | 7 (7%) | 78 (7%) | |||
| CRC family history1 | 0.05 | 0.42 | |||||
| Yes | 267 (23%) | 22 (16%) | 27 (25%) | 262 (22%) | |||
| No | 889 (77%) | 117 (84%) | 79 (75%) | 927 (78%) | |||
| Smoking History | 0.13 | 0.10 | |||||
| Current smoker | 183 (16%) | 31 (22%) | 11 (10%) | 203 (17%) | |||
| Former smoker | 532 (46%) | 62 (45%) | 47 (44%) | 547 (46%) | |||
| Never smoked | 440 (38%) | 46 (33%) | 48 (45%) | 438 (37%) | |||
| BMI | 0.27 | 0.49 | |||||
| ≥30 | 402 (35%) | 42 (30%) | 39 (38%) | 405 (34%) | |||
| <30 | 748 (65%) | 97 (70%) | 65 (63%) | 780 (66%) | |||
| History of diabetes | 0.26 | 0.96 | |||||
| Yes | 107 (9%) | 17 (12%) | 10 (9%) | 114 (10%) | |||
| No | 1049 (91%) | 122 (88%) | 96 (91%) | 1075 (90%) | |||
| History of cardiovascular disease1 | 0.84 | 0.92 | |||||
| Yes | 157 (14%) | 18 (13%) | 14 (13%) | 161 (14%) | |||
| No | 999 (86%) | 121 (87%) | 92 (87%) | 1028 (86%) | |||
| Advanced adenoma at baseline3 | <.0001 | 0.47 | |||||
| Yes | 568 (49%) | 97 (70%) | 58 (55%) | 607 (51%) | |||
| No | 588 (51%) | 42 (30%) | 48 (45%) | 582 (49%) | |||
| 3 or more adenomas at baseline | 0.05 | 0.44 | |||||
| Yes | 292 (25%) | 46 (33%) | 31 (29%) | 307 (26%) | |||
| No | 864 (75%) | 93 (67%) | 75 (71%) | 882 (74%) | |||
| Aspirin Use4 | 0.83 | 0.91 | |||||
| Yes | 364 (31%) | 45 (32%) | 34 (32%) | 375 (32%) | |||
| No | 792 (69%) | 94 (68%) | 72 (68%) | 814 (68%) | |||
| Study treatment | 0.66 | 0.23 | |||||
| Placebo | 388 (34%) | 52 (37%) | 28 (26%) | 412 (35%) | |||
| Celecoxib 200mg bid | 392 (34%) | 44 (32%) | 39 (37%) | 397 (33%) | |||
1
”yes” indicates history of parent with CRC
2
investigator reported, treatment emergent cardiovascular and thrombotic adverse events, including all events defined as myocardial infarction, cardiovascular therapeutic procedure, cerebrovascular disease, peripheral vascular disease, peripheral vascular therapeutic procedure, venous thrombosis or thromboembolism, and death or circulatory collapse due to cardiovascular cause
3
advanced adenoma = ≥ 1 cm diameter, villous or tubulovillous histology or high grade dysplasia
4
”yes” indicates using aspirin at a dose of ≤325 mg po qod or 162.5 mg po qd at study entry and continuing during study treatment