Table 3

Risk of adenomas

VariablePlacebo twice daily200 mg celecoxib twice daily400 mg celecoxib twice daily
All subjects—detection of any adenoman = 679n = 685n = 671
 Year 1 colonoscopy with any adenoma/total at risk (%)271/608 (44.6)186/613 (30.3)137/601 (22.8)
 Year 3 colonoscopy with any adenoma/total at risk (%)83/286 (29.0)66/357 (18.5)76/400 (19.0)
 Year 5 colonoscopy with any adenoma/total 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)
 RR (95% CI)0.67 (0.59-0.77)0.55 (0.48-0.64)
P 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)
 RR (95% CI)0.71 (0.62-0.80)0.62 (0.54-0.71)
P vs placebo<0.0001<0.0001
Year 5 colonoscopy with any adenoma at year 5 colonoscopy/total with year 5 colonoscopy(%)79/214 (36.9)83/207 (40.1)90/218 (41.3)
 RR (95% CI)1.09 (0.85-1.38)1.11 (0.89-1.41)
P vs placebo0.510.38
Subjects using aspirinn = 212n = 211n = 204
Cumulative incidence of adenoma detection through year 5 (%; SE)66.9 (4.2)59.7 (5.1)59.7 (5.0)
 RR (95% CI)0.75 (0.60-0.94)0.63 (0.49-0.81)
P, vs placebo0.010.0002
Year 5 colonoscopy with any adenoma at year 5 colonoscopy/total with year 5 colonoscopy(%)21/71 (29.6)30/67 (44.8)32/71 (45.1)
 RR (95% CI)1.514 (0.97-2.37)1.524 (0.98-2.37)
P vs placebo0.0660.057
Subjects not using aspirinn = 467n = 474n = 467
Cumulative incidence of adenoma detection through year 5 (%; SE)69.2 (3.0)58.6 (3.3)60.4 (3.4)
 RR (95% CI)0.69 (0.59-0.80)0.61 (0.52-0.72)
P vs placebo<0.0001<0.0001
Year 5 colonoscopy with any adenoma at year 5 colonoscopy/total with year 5 colonoscopy(%)58/143 (40.6)53/140 (37.9)58/147 (39.5)
 RR (95% CI)0.93 (0.7-1.3)0.97 (0.73-1.28)
P vs placebo0.640.81
All subjects—detection of advanced adenomas*n = 679n = 685n = 671
 Year 1 colonoscopy with advanced adenoma/total at risk (%)68/608 (11.2)26/613 (4.2)17/601 (2.8)
 Year 3 colonoscopy with advanced adenoma/total at risk (%)32/458 (7.0)18/487 (3.7)18/503 (3.6)
 Year 5 colonoscopy with advanced adenoma/total 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)
 RR (95% CI)0.43 (0.31-0.61)0.34 (0.24-0.50)
P 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)
 RR (95% CI)0.48 (0.35-0.66)0.49 (0.35-0.67)
P vs placebo<0.0001<0.0001
Year 5 colonoscopy with any adenoma at year 5 colonoscopy/total with year 5 colonoscopy (%)11/214 (5.1)13/207 (6.3)22/219 (10.1)
 RR (95% CI)1.21 (0.56-2.65)1.95 (0.97-3.92)
P vs placebo0.6210.055

NOTE: A previous report of year 3 data failed to include one patient in the placebo group. The values provided here reflect this correction.

  • *Defined as adenomas ≥1 cm in diameter, containing villous or tubulovillous histology, high grade dysplasia, carcinoma in situ, or invasive carcinoma.