Table 3.
Risk of Adenomas
| Variable | Placebo twice daily |
200mg celecoxib twice daily |
400mg celecoxib twice daily |
|---|---|---|---|
| All subjects – detection of any adenoma | n=679 | n=685 | n=671 |
| Year 1 colonoscopy – no. with any adenoma/total no. at risk (%) | 271/608 (44.6) | 186/613 (30.3) | 137/601 (22.8) |
| Year 3 colonoscopy – no. with any adenoma/total no. at risk (%) | 83/286 (29.0) | 66/357 (18.5) | 76/400 (19.0) |
| Year 5 colonoscopy – no. with any adenoma/total no. at risk (%) | 16/81 (19.8) | 33/119 (27.7) | 54/149 (36.2) |
| Cumulative incidence of adenoma detection through year 3 - % (SE) | 60.7 (2.1) | 43.2 (2.1) | 37.5 (2.1) |
| Risk Ratio (95% CI) | 0.67 (0.59, 0.77) | 0.55 (0.48, 0.64) | |
| p-value vs placebo | <0.0001 | <0.0001 | |
| Cumulative incidence of adenoma detection through year 5 - % (SE) | 68.4 (2.4) | 59.0 (2.8) | 60.1 (2.8) |
| Risk Ratio (95% CI) | 0.71 (0.62, 0.80) | 0.62 (0.54, 0.71) | |
| p-value vs placebo | <0.0001 | <0.0001 | |
| Year 5 colonoscopy – no. with any adenoma at year 5 colonoscopy/total no. with year 5 colonoscopy(%) | 79/214 (36.9) | 83/207 (40.1) | 90/218 (41.3) |
| Risk Ratio (95% CI) | 1.09 (0.85,1.38) | 1.11 (0.89. 1.41) | |
| p-value vs placebo | 0.51 | 0.38 | |
| Subjects using aspirin | n=212 | n=211 | n=204 |
| Cumulative incidence of adenoma detection through year 5 - % (SE) | 66.9 (4.2) | 59.7 (5.1) | 59.7 (5.0) |
| Risk Ratio (95% CI) | 0.75 (0.60, 0.94) | 0.63 (0.49, 0.81) | |
| p-value, vs placebo | 0.01 | 0.0002 | |
| Year 5 colonoscopy – no. with any adenoma at year 5 colonoscopy/total no. with year 5 colonoscopy(%) | 21/71 (29.6) | 30/67 (44.8) | 32/71 (45.1) |
| Risk Ratio (95% CI) | 1.514 (.97, 2.37) | 1.524 (.98, 2.37) | |
| p-value vs placebo | 0.066 | 0.057 | |
| Subjects not using aspirin | n=467 | n=474 | n=467 |
| Cumulative incidence of adenoma detection through year 5 - % (SE) | 69.2 (3.0) | 58.6 (3.3) | 60.4 (3.4) |
| Risk Ratio (95% CI) | 0.69 (0.59, 0.80) | 0.61 (0.52, 0.72) | |
| p-value vs placebo | <0.0001 | <0.0001 | |
| Year 5 colonoscopy – no. with any adenoma at year 5 colonoscopy/total no. with year 5 colonoscopy(%) | 58/143 (40.6) | 53/140 (37.9) | 58/147 (39.5) |
| Risk Ratio (95% CI) | .93 (.7, 1.3) | .97 (.73, 1.28) | |
| p-value vs placebo | .64 | .81 | |
| All subjects – detection of advanced adenomas 1 | n=679 | n=685 | n=671 |
| Year 1 colonoscopy – no. with advanced adenoma/total no. at risk (%) |
68/608 (11.2) | 26/613 (4.2) | 17/601 (2.8) |
| Year 3 colonoscopy – no. with advanced adenoma/total no. at risk (%) |
32/458 (7.0) | 18/487 (3.7) | 18/503 (3.6) |
| Year 5 colonoscopy – no. with advanced adenoma/total no. at risk (%) |
8/171 (4.7) | 10/194 (5.2) | 21/207 (10.1) |
| Cumulative incidence of advanced adenoma through year 3 - % (SE) | 17.4 (1.6) | 7.8 (1.1) | 6.3 (1.0) |
| Risk Ratio (95% CI) | 0.43 (0.31, 0.61) | 0.34 (0.24, 0.50) | |
| p-value vs placebo | <0.001 | <0.001 | |
| Cumulative incidence of advanced adenoma through year 5 - % (SE) | 21.3 (2.0) | 12.5 (1.8) | 15.8 (2.2) |
| Risk Ratio (95% CI) | 0.48 (0.35, 0.66) | 0.49 (0.35, 0.67) | |
| p-value vs placebo | <0.0001 | <0.0001 | |
| Year 5 colonoscopy – no. with any adenoma at year 5 colonoscopy/total no. with year 5 colonoscopy (%) | 11/214 (5.1) | 13/207 (6.3) | 22/219 (10.1) |
| Risk Ratio (95% CI) | 1.21(0.56, 2.65) | 1.95 (0.97, 3.92) | |
| p-value vs placebo | 0.621 | 0.055 | |
1
defined as adenomas ≥1 cm in diameter, containing villous or tubulovillous histology, high grade dysplasia, carcinoma-in-situ, or invasive carcinoma
2
A a previous report of year 3 data failed to include one patient in the placebo group. The values provided here reflect this correction.