Table 2.
Risk of Adenoma According to CYP2C9 Genotypea
| Wild-type |
CYP2C9*2 |
CYP2C9*3 |
|
|---|---|---|---|
| All patients, No. at riskb | 996 | 318 | 183 |
| Cumulative incidence, 3 yrs, % ± SE | 44.8 ± 1.6 | 52.1 ± 2.9 | 46.7 ± 3.8 |
| RR (95% CI)c | 1.0 | 1.16 (1.00–1.35) | 1.05 (0.86–1.28) |
| P valued | -- | .05 | .66 |
|
| |||
| By celecoxib treatment | |||
| Patients randomized to placebo, No. at riskb | 338 | 111 | 50 |
| Cumulative incidence, 3 yrs, % ± SE | 57.2 ± 2.8 | 68.4 ± 4.6 | 64.6 ± 7.0 |
| RR (95% CI)e | 1.0 | 1.17 (0.96–1.43) | 1.06 (0.78–1.42) |
| P valued | -- | .13 | .72 |
| Patients randomized to celecoxib 200 mg twice daily, No. at riskb | 330 | 99 | 69 |
| Cumulative incidence, 3 yrs, % ± SE | 39.9 ± 2.8 | 46.0 ± 5.3 | 49.3 ± 6.2 |
| RR (95% CI)e | 1.0 | 1.20 (0.89–1.62) | 1.25 (0.90–1.72) |
| P valued | -- | .24 | .20 |
| Patients randomized to celecoxib 400 mg twice daily, No. at riskb | 328 | 108 | 64 |
| Cumulative incidence, 3 yrs, % ± SE | 37.0 ± 2.8 | 41.0 ± 4.9 | 29.6 ± 5.9 |
| RR (95% CI)e | 1.0 | 1.11 (0.81–1.53) | 0.79 (0.50–1.25) |
| P valued | -- | .50 | .72 |
|
| |||
| By aspirin strata | |||
| Patients taking aspirin,f No. at riskb | 303 | 116 | 62 |
| Cumulative incidence, 3 yrs, % ± SE | 44.6 ± 3.0 | 60.4 ± 4.7 | 47.1 ± 6.6 |
| RR (95% CI)g | 1.0 | 1.44 (1.14–1.81) | 1.15 (0.82–1.60) |
| P valued | -- | .003 | .43 |
| Patients not taking aspirin,f No. at riskb | 693 | 202 | 121 |
| Cumulative incidence, 3 yrs, % ± SE | 44.9 ± 2.0 | 47.4 ± 3.7 | 46.4 ± 4.7 |
| RR (95% CI)g | 1.0 | 1.02 (0.84–1.24) | 1.00 (0.78–1.28) |
| P valued | -- | .82 | .99 |
Wild-type genotypes include individuals with no *2 (R144C) or *3 (I359L) alleles. CYP2C9*2 genotypes include individuals with ≥ one *2 allele. CYP2C9*3 genotypes include individuals with ≥ one *3 allele. Individuals with one *2 allele and one *3 allele were classified as having CYP2C9*3 genotypes.
No. at risk include patients who underwent a follow-up colonoscopy at year 1 and/or year 3.
Relative risk calculated by the Mantel-Cox test, with stratification for celecoxib treatment, aspirin use, time, age and sex, with the wild-type genotype as the referent group.
The P value is the Cochran-Mantel-Haenszel test of general association compared to the wild-type genotype.
Relative risk calculated by the Mantel-Cox test, with stratification for aspirin use, time, age, and sex, with the wild-type genotype as the referent group.
Patients were stratified at study entry according to the use or nonuse of low-dose aspirin (325 mg or less every other day or 162.5 mg or less every day). Patients not taking aspirin at baseline were required to abstain from taking it during the trial.
Relative risk calculated by the Mantel-Cox test with stratification for celecoxib treatment, time, age, and sex, with the wild-type genotype as the referent group.