Table 2.

Risk of adenoma according to serum hsCRP levels

hsCRP ≤1 mg/LhsCRP 1–3 mg/LhsCRP ≥3 mg/L
All patientsa
No. at risk533529453
 Cumulative incidence, 3 y, % ± SE42 ± 243 ± 241 ± 2
 RR (95% CI)1 (ref)1.02 (0.85–1.22)1.10 (0.90–1.34)
P0.860.36
By celecoxib treatment
Patients randomized to placebo, no. at risk179177148
 Cumulative incidence, 3 y, % ± SE54 ± 453 ± 457 ± 4
 RR (95% CI)1 (ref)0.98 (0.74–1.3)1.22 (0.9–1.64)
P0.910.20
Patients randomized to celecoxib 200-mg-bid, no. at risk163190153
 Cumulative incidence, 3 y, % ± SE36 ± 441 ± 437 ± 4
 RR (95% CI)1 (ref)1.18 (0.84–1.64)1.13 (0.79–1.62)
P0.340.50
Patients randomized to celecoxib 400-mg-bid, no. at risk191162152
 Cumulative incidence, 3 y, % ± SE35 ± 334 ± 430 ± 4
 RR (95% CI)1 (ref)0.89 (0.63–1.27)0.94 (0.64–1.38)
P0.520.76
Pinteraction0.530.58
By low-dose aspirin stratab
Patients taking aspirin, no. at risk171183129
 Cumulative incidence, 3 y, % ± SE40 ± 449 ± 441 ± 4
 RR (95% CI)1 (ref)1.34 (0.98–1.82)1.24 (0.87–1.78)
P0.070.23
Patients not taking aspirin, no. at risk362346324
 Cumulative incidence, 3 y, % ± SE43 ± 340 ± 341 ± 4
 RR (95% CI)1 (ref)0.89 (0.71–1.11)1.04 (0.82–1.31)
P0.290.77
Pinteraction0.050.80
By sex
Men, no. at risk395391249
 Cumulative incidence, 3 y, % ± SE45 ± 246 ± 248 ± 3
 RR (95% CI)1 (ref)1.01 (0.82–1.23)1.11 (0.88–1.40)
P0.950.37
Women, no. at risk138138204
 Cumulative incidence, 3 y, % ± SE34 ± 434 ± 433 ± 3
 RR (95% CI)1 (ref)1.05 (0.70–1.57)1.03 (0.71–1.50)
P0.810.86
Pinteraction0.890.81
By postmenopausal hormone usec
Patients taking hormones, no. at risk2949110
 Cumulative incidence, 3 y, % ± SE30 ± 829 ± 635 ± 4
 RR (95% CI)1 (ref)1.02 (0.44–2.37)1.25 (0.60–2.59)
P0.970.55
Patients not taking hormones, no. at risk1098994
 Cumulative incidence, 3 y, % ± SE35 ± 537 ± 530 ± 5
 RR (95% CI)1 (ref)1.12 (0.70–1.79)0.95 (0.59–1.54)
P0.630.83
Pinteraction0.740.56
By body mass indexd
Patients with high body mass index, no. at risk175279297
 Cumulative incidence, 3 y, % ± SE48 ± 441 ± 341 ± 3
 RR (95% CI)1 (ref)0.90 (0.68–1.19)0.98 (0.74–1.30)
P0.440.91
Patients with low body mass index, no. at risk358250156
 Cumulative incidence, 3 y, % ± SE39 ± 345 ± 341 ± 4
 RR (95% CI)1 (ref)1.12 (0.87–1.43)1.16 (0.86–1.56)
P0.370.33
Pinteraction0.240.49
By statin use
Patients taking statins, no. at risk14214398
 Cumulative incidence, 3 y, % ± SE46 ± 442 ± 451 ± 5
 RR (95% CI)1 (ref)0.96 (0.68–1.36)1.22 (0.84–1.78)
P0.810.30
Patients not taking statins, no. at risk391386355
 Cumulative incidence, 3 y, % ± SE41 ± 243 ± 238 ± 3
 RR (95% CI)1 (ref)1.05 (0.85–1.3)1.05 (0.83–1.32)
P0.660.68
Pinteraction0.670.52
  • aNo. at risk includes patients who underwent a follow-up colonoscopy at years 1 and/or 3. A patient with a colonoscopy at year 3 but with no colonoscopy at year 1 was included in the analysis through year 1, with the assumption that the patient had no adenoma at year 1, and was then included in the analysis through year 3 according to the findings of the colonoscopy at year 3. The analyses at year 3 excluded patients with an adenoma at year 1 colonoscopy and patients with no adenoma at year 1 and no colonoscopy at year 3 (4). All RRs are multivariate-adjusted as described in the methods. P values for interaction were assessed by using cross-product terms for each celecoxib treatment group and each risk factor strata.

  • bAt the time of randomization, patients were stratified according to use of low-dose aspirin, defined as ≤325 mg/every other day or ≤162.5 mg/y.

  • cAnalyses were restricted to women.

  • dHigh body mass index defined as ≥ median (28 mg/kg2) and low body mass index defined as < median.