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 ± SD | 64 ± 10 | 62 ± 10 | ||
Range | 49-74 | 41-76 | ||
Age >75 y, n (%) | 0 | 1 (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) |
. | Placebo (n = 9) . | DFMO/sulindac (n = 16) . | ||
---|---|---|---|---|
Age (y) | ||||
Mean ± SD | 64 ± 10 | 62 ± 10 | ||
Range | 49-74 | 41-76 | ||
Age >75 y, n (%) | 0 | 1 (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.