Table 2

Baseline characteristics of the patients who have at least one grade ≥3 cardiovascular adverse event, defined as myocardial infarction, coronary artery disease, congestive heart failure, cerebrovascular accident, and chest pain

Placebo (n = 9)DFMO/sulindac (n = 16)
Age (y)
 Mean ± SD64 ± 1062 ± 10
 Range49-7441-76
Age >75 y, n (%)01 (6)
Use of low-dose aspirin, n (%)2 (22)10 (63)
History of cardiovascular disease, n (%)*7 (78)9 (56)
History of high blood pressure or hypertension or medication taken, n (%)*6 (67)5 (31)
History of hyperlipidemia or medication taken, n (%)*3 (33)6 (38)
History of diabetes or medication taken, n (%)*1 (11)4 (25)
Current or prior cigarette smoker, n (%)*,1/5 (20)3/7 (43)
Risk score*,,:
 Low risk score, n (%)3 (33)3 (19)
 Moderate risk score, n (%)3 (33)4 (25)
 High risk score, n (%)3 (33)9 (56)
  • *The denominator is the number of subjects for whom information was recorded in either medical history form or concomitant medication form. Missing values are not included.

  • Self-reported information.

  • Risk score, derived from Solomon et al. (7): low—no known risk factors; moderate (one of the following)—age > 75 y, HTN or medication taken, hyperlipidemia or medication taken, current or prior smoker, or use of low dose ASA; high—diabetes or medication taken, prior history of cardiovascular disease (coronary artery disease, myocardial infarction, congestive heart failure, cerebrovascular accident), or ≥2 risk factors from moderate category.