Table 1

Baseline characteristics of the patients were evenly distributed between arms

CharacteristicPlacebo (n = 184)DFMO/sulindac (n = 191)
Age, y
 Median6060
 Mean ± SD61 ± 8.260 ± 8.6
 Range42-7841-79
Male sex, n (%)138 (75.0)147 (77.0)
Race or ethnic group, n (%)
 White158 (85.9)155 (81.2)
 Black6 (3.3)10 (5.2)
 Hispanic12 (6.5)14 (7.3)
 Asian or Pacific Islander4 (2.2)9 (4.7)
 Other4 (2.2)3 (1.6)
Body mass index (mean ± SD)
 Men28.4 ± 4.529.2 ± 5.5
 Women29.4 ± 7.527.7 ± 5.8
No. reported adenomas*2.51 ± 2.32.49 ± 2.2
Largest adenoma ≥1 cm, n (%)40 (21.7)38 (19.9)
Use of low-dose aspirin, n (%)69 (37.5)77 (40.3)
History of cardiovascular disease, n (%)67/155 (43.2)73/158 (46.2)
History of high blood pressure or hypertension, n (%)47/155 (30.3)48/158 (30.4)
History of diabetes, n (%)21/151 (13.9)25/152 (16.4)
Current or prior cigarette smoker, n (%)‡,§41/99 (41.4)42/100 (42.0)
  • *Placebo, n = 183; DFMO/sulindac, n = 189. Number of polyps reported as “multiple” for three patients.

  • Adenoma is defined as tubular, tubulovillous, villous, cancer in situ, adenoma, or tubular adenoma with high-grade dysplasia.

  • The denominator is the number of subjects for whom information was recorded. Missing values are not included.

  • §Self-reported information.