Table 4.

Risk of adenoma at 5 years according to discontinuation of celecoxib treatment, stratified by aspirin use and UGT1A6 genotypea

Prior placeboPrior celecoxib, 200 mg twice dailyPrior celecoxib, 400 mg twice daily
All genotypes
All patients, no. at riskb183166189
 No. with adenoma, (%)c68 (37)64 (39)81 (43)
 RR (95% CI)d1.01.04 (0.79–1.36)1.14 (0.88–1.47)
Pe0.800.31
Aspirin users, no. at riskb635560
 No. with adenoma, (%)c19 (30)24 (44)29 (48)
 RR (95% CI)f1.01.45 (0.89–2.34)1.59 (1.00–2.53)
Pe0.130.05
Non-aspirin users, no. at riskb120111129
 No. with adenoma, (%)c49 (41)40 (36)52 (40)
 RR (95% CI)f1.00.88 (0.64–1.23)0.98 (0.72–1.32)
Pe0.460.87
Patients with wild-type genotypes
All wild-type genotypes, no. at riskb797384
 No. with adenoma, (%)c30 (38)27 (37)38 (45)
 RR (95% CI)g1.00.97 (0.64–1.46)1.16 (0.81–1.68)
Pe0.890.42
Aspirin users, no. at riskb322727
 No. with adenoma, (%)c10 (31)11 (41)10 (37)
 RR (95% CI)h1.01.30 (0.66–2.59)1.19 (0.58–2.41)
Pe0.450.64
Non-aspirin users, no. at riskb474657
 No. with adenoma, (%)c20 (43)16 (35)28 (49)
 RR (95% CI)h1.00.82 (0.49–1.37)1.15 (0.76–1.76)
Pe0.440.51
Patients with variant genotypes
All variant genotypes, no. at riskb10493105
 No. with adenoma, (%)c38 (37)37 (40)43 (41)
 RR (95% CI)g1.01.09 (0.76–1.56)1.12 (0.79–1.58)
Pe0.640.52
Aspirin users, no. at riskb312833
 No. with adenoma, (%)c9 (29)13 (46)19 (58)
 RR (95% CI)h1.01.60 (0.81–3.15)1.98 (1.06–3.70)
Pe0.170.02
Non-aspirin users, no. at riskb736572
 No. with adenoma, (%)c29 (40)24 (37)24 (33)
 RR (95% CI)h1.00.93 (0.61–1.42)0.84 (0.55–1.29)
Pe0.740.43
  • aRisk of adenoma on the colonoscopy at year 5 among 538 patients enrolled in the double-blinded extension of the APC trial. At the time of the year 5 colonoscopy, 94% had been off study drug for at least 1 year. 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 the year 5 colonoscopy.

  • cNo. with adenoma includes the results of the colonoscopy at year 5 without considering adenomas found at earlier time points.

  • dRisk ratio controlling for genotype and aspirin use among patients who underwent year 5 colonoscopy with placebo as the referent group.

  • eP value is the Cochran–Mantel–Haenszel test of general association compared with the placebo group.

  • fRisk ratio, controlling for genotype among patients who underwent year 5 colonoscopy with placebo as the referent group.

  • gRisk ratio, controlling for aspirin use among patients who underwent year 5 colonoscopy with placebo as the referent group.

  • hRisk ratio among patients who underwent year 5 colonoscopy with placebo as the referent group.