Table 1.
Characteristics of Randomized Participants Selected for Plasma Metabolomics Study, by Aspirin Treatment Group (N=523)
| Placebo (N=180) |
81 mg Aspirin (N=177) |
325 mg Aspirin (N=166) |
Pa | |
|---|---|---|---|---|
| Baseline Characteristics: | ||||
| Age at Enrollment, Mean ± SD | 58.5 ± 9.5 | 57.5 ± 9.3 | 58.4 ± 9.2 | 0.55 |
| Female, N (%) | 62 (34.4) | 63 (35.6) | 59 (35.5) | 0.97 |
| Race/ethnicity, N (%) | 0.26 | |||
| White, Non-Hispanic | 152 (84.4) | 149 (84.2) | 151 (91.0) | |
| Black, Non-Hispanic | 12 (6.7) | 12 (6.8) | 3 (1.8) | |
| Hispanic | 10 (5.6) | 10 (5.7) | 5 (3.0) | |
| Other | 6 (3.3) | 6 (3.4) | 7 (4.2) | |
| Body-Mass Index, kg/m2, mean ± SD | 27.1 ± 4.1 | 27.2 ± 4.2 | 27.8 ± 4.5 | 0.28 |
| Current Smoker, N (%) | 25 (13.9) | 23 (13.1) | 22 (13.3) | 0.76 |
| Alcohol Use, N (%) | 119 (68.4) | 106 (62.0) | 101 (64.3) | 0.45 |
| Family History of Colorectal Cancer, N (%) | 51 (37.2) | 58 (39.5) | 60 (45.8) | 0.33 |
| Dietary Linoleic Acid Intake, gr/day, mean ± SD | 12.3 ± 6.8 | 10.9 ± 6.2 | 11.8 ± 7.1 | 0.17 |
|
| ||||
| Study and Follow-up Characteristics: | ||||
| Allocated to Folate Treatmentb, N (%) | 81 (49.1) | 85 (53.8) | 78 (53.1) | 0.66 |
| Study Follow-Up Time, Mean ± SDc | 32.7 ± 3.7 | 32.3 ± 2.5 | 32.5 ± 2.6 | 0.58 |
| ≥1 Adenoma at Year 3 Colonoscopy, N (%) | 75 (41.7) | 61 (34.5) | 64 (38.6) | 0.37 |
| ≥1 Advanced Adenoma at Year 3 Colonoscopyd, N (%) | 20 (11.1) | 12 (6.8) | 16 (9.6) | 0.36 |
| High-risk Findings at Year 3 Colonoscopye, N (%) | 29 (16.1) | 17 (9.6) | 20 (12.1) | 0.17 |
| Baseline plasma thaw history | 0.18 | |||
| 0 times | 71 (39.4) | 92 (52.0) | 72 (43.6) | |
| 1 time | 106 (58.9) | 83 (46.9) | 91 (55.2) | |
| 2 times | 3 (1.7) | 2 (1.1) | 2 (1.2) | |
| Year 3 plasma thaw history | 0.12 | |||
| 0 times | 33 (18.3) | 30 (17.0) | 33 (19.9) | |
| 1 time | 147 (81.7) | 146 (82.5) | 128 (77.1) | |
| 2 times | 0 | 1 (0.6) | 5 (3.0) | |
N’s for missing data for smoking status: 1 aspirin (81 mg), 1 aspirin (325 mg); alcohol use: 6 placebo, 6 aspirin (81 mg), 9 aspirin (325 mg); family history of colorectal cancer: 43 placebo, 30 aspirin (81 mg), 35 aspirin (325 mg); dietary linoleic acid intake: 5 placebo, 6 aspirin (81 mg), 8 aspirin (325 mg); baseline plasma thaw history: 1 aspirin (325 mg).
P-values for comparisons among the three treatment groups: Pearson chi-square tests for categorical variables and analysis of variance tests for continuous variables. Fisher’s exact test used for number of thaws.
Enrolled in study before randomization to folate began: 15 placebo, 19 aspirin (81 mg), 19 aspirin (325 mg).
Time in months from enrollment to year 3 end of treatment colonoscopy
Advanced adenomas are those with cancer, high-grade dysplasia, >25% villous component, or diameter ≥1 cm.
High-risk findings refers to ≥1 advanced adenomas or ≥3 adenomas of any type.