Table 1.
Baseline demographics, intervention adherence, and adverse events by intervention arm.
| Arm A Placebo (n = 20) | Arm B Low-dose aspirin (n = 20) | Arm C High-dose aspirin (n = 20) | Total (n = 60) | p value | |
|---|---|---|---|---|---|
| Age (y) | 0.7185a | ||||
| Mean (S.D.) | 61.7 (12.0) | 58.1 (12.6) | 60.2 (11.1) | 60.0 (11.8) | |
| Median | 61.0 | 59.5 | 62.0 | 61.0 | |
| Range | (32.0–86.0) | (34.0–79.0) | (35.0–80.0) | (32.0–86.0) | |
| Sex, n (%) | 0.8998b | ||||
| Female | 2 (10.0%) | 4 (20.0%) | 3 (15.0%) | 9 (15.0%) | |
| Male | 18 (90.0%) | 16 (80.0%) | 17 (85.0%) | 51 (85.0%) | |
| ECOG performance score, n (%) | 1.0000b | ||||
| 0 | 19 (95.0%) | 20 (100.0%) | 20 (100.0%) | 59 (98.3%) | |
| 1 | 1 (5.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.7%) | |
| Length of Barrett's segment, n (%) | 0.6822b | ||||
| < 5 cm if circumferential involvement | 9 (45.0%) | 9 (45.0%) | 12 (60.0%) | 30 (50.0%) | |
| > = 5 cm of circumferential involvement | 11 (55.0%) | 11 (55.0%) | 8 (40.0%) | 30 (50.0%) | |
| BMI | 0.1715a | ||||
| Mean (S.D.) | 28.0 (2.7) | 29.0 (4.5) | 30.3 (5.1) | 29.1 (4.3) | |
| Median | 27.5 | 28.6 | 29.1 | 28.1 | |
| Range | (25.3–36.5) | (22.4–40.4) | (23.4–43.8) | (22.4–43.8) | |
| Prior history of NSAID use, n (%) | 0.3103b | ||||
| No | 20 (100.0%) | 19 (95.0%) | 17 (85.0%) | 56 (93.3%) | |
| Yes | 0 (0.0%) | 1 (5.0%) | 3 (15.0%) | 4 (6.7%) | |
| Intervention Adherence: | |||||
| No. of Esomoprazole run-in pills | 0.5812a | ||||
| Mean (S.D.) | 55.7 (3.5) | 56.8 (3.8) | 56.4 (4.5) | 56.3 (3.9) | |
| Median | 55.5 | 57.0 | 56.0 | 56.0 | |
| Range | (49.0–62.0) | (49.0–66.0) | (46.0–64.0) | (46.0–66.0) | |
| Esomeprazole run-in compliance | 0.8022a | ||||
| Mean (S.D.) | 99.9 (0.4) | 99.8 (0.5) | 99.3 (2.6) | 99.7 (1.6) | |
| Median | 100.0 | 100.0 | 100.0 | 100.0 | |
| Range | (98.1–100.0) | (98.2–100.0) | (88.5–100.0) | (88.5–100.0) | |
| No. of Esomoprazole intervention pills | 0.9126a | ||||
| Mean (S.D.) | 55.9 (3.9) | 56.3 (5.6) | 56.0 (6.7) | 56.1 (5.4) | |
| Median | 56.0 | 56.0 | 56.5 | 56.0 | |
| Range | (49.0–64.0) | (48.0–68.0) | (37.0–68.0) | (37.0–68.0) | |
| Esomeprazole intervention compliance | 0.4615a | ||||
| Mean (S.D.) | 99.4 (1.9) | 99.8 (0.9) | 98.6 (6.5) | 99.3 (3.9) | |
| Median | 100.0 | 100.0 | 100.0 | 100.0 | |
| Range | (91.7–100.0) | (96.2–100.0) | (71.2–100.0) | (71.2–100.0) | |
| No. of Aspirin 81 mg/placebo intervention pills | 0.8260a | ||||
| Mean (S.D.) | 27.8 (1.7) | 28.1 (2.7) | 28.2 (2.3) | 28.0 (2.2) | |
| Median | 28.0 | 28.0 | 28.0 | 28.0 | |
| Range | (25.0–32.0) | (24.0–34.0) | (25.0–33.0) | (24.0–34.0) | |
| Aspirin 81 mg/placebo compliance | 0.3555a | ||||
| Mean (S.D.) | 99.0 (3.7) | 99.8 (0.9) | 100.0 (0.0) | 99.6 (2.2) | |
| Median | 100.0 | 100.0 | 100.0 | 100.0 | |
| Range | (83.9–100.0) | (96.0–100.0) | (100.0–100.0) | (83.9–100.0) | |
| No. of Aspirin 325 mg/placebo intervention pills | 0.9346a | ||||
| Mean (S.D.) | 27.8 (1.8) | 28.2 (2.7) | 28.1 (2.2) | 28.0 (2.2) | |
| Median | 28.0 | 28.0 | 28.0 | 28.0 | |
| Range | (25.0–32.0) | (24.0–34.0) | (25.0–33.0) | (24.0–34.0) | |
| Aspirin 325 mg/placebo Compliance | 0.9989a | ||||
| Mean (S.D.) | 99.8 (0.8) | 99.8 (0.9) | 99.8 (0.8) | 99.8 (0.8) | |
| Median | 100.0 | 100.0 | 100.0 | 100.0 | |
| Range | (96.4–100.0) | (96.0–100.0) | (96.6–100.0) | (96.0–100.0) |
a
Kruskal Wallis.
b
Fisher Exact.