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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 ± SD 64 ± 10 62 ± 10 
 Range 49-74 41-76 
Age >75 y, n (%) 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 (%) 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.

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