Table 3.

Risk of adenoma according to aspirin use, stratified by celecoxib treatment and UGT1A6 genotypea

Non-aspirin userAspirin user
All genotypes
All patients, no. at riskb1,010474
 Cumulative incidence, 3 y, % ± SE45.6 ± 1.648.8 ± 2.4
 RR (95% CI)c1.00.98 (0.86–1.15)
Pd0.79
Randomized to placebo, no. at riskb331162
 Cumulative incidence, 3 y, % ± SE59.2 ± 2.861.0 ± 4.0
 RR (95% CI)e1.00.96 (0.79–1.16)
Pd0.68
Randomized to celecoxib 200 mg twice daily, no. at riskb337160
 Cumulative incidence, 3 y, % ± SE42.0 ± 2.846.0 ± 4.1
 RR (95% CI)e1.01.02 (0.80–1.31)
Pd0.86
Randomized to celecoxib 400 mg twice daily, no. at riskb342152
 Cumulative incidence, 3 y, % ± SE36.0 ± 2.738.7 ± 4.1
 RR (95% CI)e1.00.97 (0.72–1.30)
Pd0.83
Patients with wild-type genotypes
All wild-type genotypes, no. at riskb434212
 Cumulative incidence, 3 y, % ± SE45.9 ± 2.548.3 ± 3.6
 RR (95% CI)f1.00.96 (0.79–1.18)
Pd0.73
Randomized to placebo, no. at riskb13874
 Cumulative incidence, 3 y, % ± SE61.4 ± 4.264.3 ± 6.0
 RR (95% CI)g1.00.96 (0.73–1.26)
Pd0.76
Randomized to celecoxib 200 mg twice daily, no. at riskb14469
 Cumulative incidence, 3 y, % ± SE41.0 ± 4.344.0 ± 6.2
 RR (95% CI)g1.00.97 (0.66–1.43)
Pd0.88
Randomized to celecoxib 400 mg twice daily, no. at riskb15269
 Cumulative incidence, 3 y, % ± SE36.5 ± 4.035.7 ± 6.1
 RR (95% CI)g1.00.97 (0.62–1.50)
Pd0.89
Patients with variant genotypes
All variant genotypes, no. at riskb576262
 Cumulative incidence, 3 y, % ± SE45.4 ± 2.249.0 ± 3.2
 RR (95% CI)f1.01.00 (0.83–1.19)
Pd0.96
Randomized to placebo, no. at riskb19388
 Cumulative incidence, 3 y, % ± SE57.6 ± 3.758.4 ± 5.4
 RR (95% CI)g1.00.96 (0.74–1.25)
Pd0.77
Randomized to celecoxib 200 mg twice daily, no. at riskb19391
 Cumulative incidence, 3 y, % ± SE42.6 ± 3.747.4 ± 5.1
 RR (95% CI)g1.01.06 (0.77–1.47)
Pd0.72
Randomized to celecoxib 400 mg twice daily, no. at riskb19083
 Cumulative incidence, 3 y, % ± SE35.6 ± 3.640.7 ± 5.6
 RR (95% CI)g1.00.97 (0.66–1.43)
Pd0.86
  • aCumulative risk of adenoma through follow-up colonoscopy at year 3. Patients were stratified at study entry according to the use or nonuse of low-dose aspirin (≤325 mg every other day or ≤162.5 mg every day). Patients not taking aspirin at baseline were required to abstain from taking it during the trial. Wild-type UGT1A6 genotypes include individuals with no T181A or R184S alleles. Variant UGT1A6 genotypes include individuals with ≥1 variant (T181 or R184S) allele.

  • bNo. at risk includes patients who underwent a follow-up colonoscopy at year 1 and/or 3.

  • cRisk ratio is estimated by the Mantel–Cox method, with stratification for treatment, genotype, time, age, and sex, with non-aspirin users as the referent group.

  • dP value is the Cochran–Mantel–Haenszel test of general association compared with the non-aspirin user group.

  • eRisk ratio is estimated by the Mantel–Cox method, with stratification for genotype, time, age, and sex, with non-aspirin users as the referent group.

  • fRisk ratio is estimated by the Mantel–Cox method, with stratification for treatment, time, age, and sex, with non-aspirin users as the referent group.

  • gRisk ratio is estimated by the Mantel–Cox method, with stratification for time, age, and sex, with non-aspirin users as the referent group.