Table 1.
Baseline Characteristics of the Patients According to CYP2C9 Genotype a
| Characteristics |
All (n =1660) |
Wild-type (n = 1102) |
CYP2C9*2 (n = 357) |
CYP2C9*3 (n = 201) |
P valueb |
|---|---|---|---|---|---|
| Age, median y, (range) | 59 (31, 88) | 59 (31, 84) | 59 (34, 88) | 60 (38, 80) | .09 |
| Women (%) | 31.9 | 32.4 | 29.7 | 33.3 | .57 |
| Race or ethnic group (%)c | |||||
| Non-hispanic White | 92.2 | 89.7 | 96.9 | 98.0 | <.001 |
| Non-hispanic Black | 5.2 | 7.0 | 2.0 | 1.0 | |
| Hispanic | 1.8 | 2.3 | 1.0 | 0.5 | |
| Asian/Pacific Islander/Other | 0.8 | 1.0 | 0.3 | 0.5 | |
| Current cigarette smoker (%) | 16.6 | 17.4 | 16.3 | 12.4 | .25 |
| Body-mass indexd | |||||
| Men | 28.8 (0.1) | 28.8 (0.2) | 28.7 (0.3) | 28.8 (0.4) | .99 |
| Women | 29.0 (0.3) | 28.8 (0.3) | 29.6 (0.7) | 29.0 (0.8) | .56 |
| Colorectal cancer in a parent (%) | 21 | 20.3 | 25.2 | 17.9 | .08 |
| Findings at baseline colonoscopy | |||||
| No. of adenomas | 2.1 (0.04) | 2.1 (0.05) | 2.1 (0.08) | 2.1 (0.11) | .96 |
| At least one adenoma ≥ 1cm (%) | 42.6 | 44.1 | 39.2 | 43.8 | .26 |
| Multiple adenomas (%) | 55.9 | 56.7 | 55.5 | 52.0 | .47 |
| Adenoma burden, cm.e | 1.50 (0.03) | 1.50 (0.04) | 1.45 (0.06) | 1.51 (0.09) | .81 |
| History of cardiovascular events (%)f | 14.2 | 14.0 | 17.1 | 10.5 | .09 |
| History of hypertension (%) | 40.4 | 37.8 | 46.5 | 43.8 | .01 |
| History of diabetes (%) | 9.3 | 9.0 | 8.7 | 12.4 | .27 |
| Use of low-dose aspirin (%)g | 32.0 | 29.7 | 37.0 | 35.8 | .02 |
| Randomized to placebo (%) | 33.7 | 34.5 | 33.9 | 29.4 | -- |
| Randomized to celecoxib, 200 mg twice daily (%) | 33.1 | 32.7 | 32.5 | 36.3 | -- |
| Randomized to celecoxib, 400 mg twice daily (%) | 33.2 | 32.9 | 33.6 | 34.3 | -- |
Data are expressed as mean (SD) unless otherwise indicated. 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.
Test of difference between wild-type, CYP2C9*2, and CYP2C9*3 genotype groups was calculated by analysis of variance for continuous variables, χ2 for categorical variables.
Race or ethnic group was determined by the investigator using predefined categories.
Body-mass index is the weight in kilograms divided by the square of the height in meters.
The adenoma burden was defined as the sum of the diameter of all adenomas reported during colonoscopy at baseline.
Cardiovascular events were defined as myocardial infarction, cerebrovascular disease, congestive heart failure, angina, and atherosclerotic heart disease.
Low-dose aspirin was defined as 325 mg or less every other day or 162.5 mg or less every day.