Table 1.

Baseline characteristics

Nonusers (N = 3,169; 50%)Aspirin (N = 1,368; 21%)NSAIDs (N = 1,176; 18%)Aspirin and NSAIDs (N = 677; 11%)P valuea
Age<0.001
 Mean (SD)62.7 (6.0)63.9 (5.8)61.5 (6.0)62.7 (6.1)
 Median (Q1, Q3)63.0 (58.0, 67.0)64.0 (60.0, 68.0)61.0 (57.0, 66.0)63.0 (58.0, 67.0)
Ethnic group0.004b
 White2,910 (92%)1,266 (93%)1,057 (90%)635 (94%)
 Black50 (2%)33 (2%)22 (2%)12 (2%)
 Other209 (6%)69 (5%)97 (8%)30 (4%)
Geographic region<0.001
 US/Canada457 (14%)535 (39%)255 (22%)299 (44%)
 Europe2,195 (69%)675 (49%)656 (56%)243 (36%)
 Other517 (16%)158 (12%)265 (23%)135 (20%)
BMI (kg/m2)<0.001
 Mean (SD)26.9 (3.6)27.7 (3.9)27.5 (3.8)28.4 (4.2)
 Median (Q1, Q3)26.5 (24.5, 28.9)27.3 (25.1, 29.5)27.1 (25.1, 29.4)27.8 (25.5, 30.6)
Suspicious DRE89 (3%)59 (4%)53 (5%)40 (6%)<0.001b
Prostate volume (cc)<0.001
 Mean (SD)45.4 (17.5)47.1 (17.3)44.6 (17.7)45.1 (17.2)
 Median (Q1, Q3)43.3 (33.0, 56.3)45.3 (34.6, 58.3)42.3 (32.0, 55.4)43.2 (33.2, 55.1)
PSA (ng/mL)0.007
 Median (Q1, Q3)5.8 (4.5, 7.4)5.6 (4.3, 7.2)5.6 (4.3, 7.4)5.5 (4.3, 7.1)
Biopsy Gleason score0.742b
 2–6520 (69%)197 (69%)180 (72%)103 (70%)
 3+4160 (21%)66 (23%)49 (20%)35 (24%)
 ≥4+373 (10%)23 (8%)21 (8%)9 (6%)
Smoker<0.001b
 Yes1,588 (50%)590 (43%)488 (41%)257 (38%)
 No469 (15%)182 (13%)184 (16%)88 (13%)
 Former1,112 (35%)596 (44%)504 (43%)332 (49%)
Alcohol (drinks/week)0.012
 Median (Q1, Q3)3 (1, 7)2 (0, 7)3 (0, 10)3 (0, 10)
Statin user ever534 (17%)759 (55%)272 (23%)360 (53%)<0.001b
Hypertension698 (22%)475 (35%)225 (19%)183 (27%)<0.001b
Coronary artery disease135 (4%)266 (19%)49 (4%)97 (14%)<0.001b
Diabetes168 (5%)110 (8%)52 (4%)43 (6%)<0.001b
Treatment arm0.645b
 Placebo1,626 (51%)676 (49%)598 (51%)351 (52%)
 Dutasteride1,543 (49%)692 (51%)578 (49%)326 (48%)
  • aP value by Kruskal–Wallis, except where noted.

  • bP value by χ2.