Table 1.
Baseline Characteristics of Men in the Cardiovascular Trial
| Characteristic | Treatment Group | |
|---|---|---|
| Testosterone (n = 73) | Placebo (n = 65) | |
| Demographics | ||
| Agea | ||
| Mean (SD), y | 70.5 (5.7) | 72.0 (5.7) |
| No. (%) | ||
| ≤75 y | 63 (86.3) | 51 (78.5) |
| >75 y | 10 (13.7) | 14 (21.5) |
| Race, No. (%) | ||
| White | 60 (82.2) | 52 (80.0) |
| Black | 7 (9.6) | 8 (12.3) |
| Otherb | 6 (8.2) | 5 (7.7) |
| Ethnicity, No. (%) | ||
| Hispanic | 5 (6.8) | 2 (3.1) |
| Non-Hispanic | 68 (93.2) | 63 (96.9) |
| College graduate, No. (%) | 41 (56.2) | 36 (55.4) |
| Married or living with partner, No. (%) | 48 (65.8) | 48 (73.8) |
| Study site, No. (%)a | ||
| Albert Einstein College of Medicine | 5 (6.8) | 8 (12.3) |
| Baylor College of Medicine | 9 (12.3) | 9 (13.8) |
| Boston University Medical Center | 1 (1.4) | 0 |
| Northwestern University | 6 (8.2) | 10 (15.4) |
| Harbor-UCLA Medical Center | 21 (28.8) | 16 (24.6) |
| University of Florida | 4 (5.5) | 5 (7.7) |
| University of Pittsburgh | 8 (11.0) | 6 (9.2) |
| VA Puget Sound Health Care System | 7 (9.6) | 2 (3.1) |
| Yale School of Medicine | 12 (16.4) | 9 (13.8) |
| Main trial participation, No. (%)a | ||
| Sexual Function Trial | 49 (67.1) | 39 (60.0) |
| Physical Function Trial | 34 (46.6) | 35 (53.8) |
| Vitality Trial | 51 (69.9) | 40 (61.5) |
| Concomitant conditions | ||
| BMI | ||
| Mean (SD) | 30.6 (3.8) | 30.4 (3.5) |
| >30, No. (%) | 45 (61.6) | 37 (56.9) |
| Alcohol use, No. of drinks/wk, median (IQR) | 0 (0–2) | 1.0 (0–2) |
| Smoking, No. (%) | ||
| Current smoker | 4 (5.5) | 10 (15.4) |
| Ever smoker | 48 (65.8) | 43 (66.2) |
| Diabetes, No. (%) | 23 (31.5) | 19 (29.2) |
| Hypertension, No. (%) | 49 (67.1) | 42 (64.6) |
| High cholesterol, No. (%) | 46 (63.0) | 42 (64.6) |
| History of myocardial infarction, No. (%) | 6 (8.2) | 6 (9.2) |
| History of stroke, No. (%) | 0 | 2 (3.1) |
| Sleep apnea, No. (%) | 14 (19.2) | 12 (18.5) |
| Coronary artery revascularization, No. (%) | 4 (5.5) | 6 (9.2) |
| ACC/AHA risk score, mean (SD), %c | 24 (10.9) | 27 (10.5) |
| Coronary artery calcium score in Agatston units, No. (%)d | ||
| 0 | 7 (9.6) | 3 (4.8) |
| >0 to <300 | 34 (46.6) | 22 (34.9) |
| ≥300 | 32 (43.8) | 38 (60.3) |
| Medication use, No. (%) | ||
| Antidiabetics | 20 (27.4) | 18 (27.7) |
| Statins | 45 (61.6) | 40 (61.5) |
| Antihypertensives | 46 (63.0) | 39 (60.0) |
| Antidepressantsa | 8 (12.3) | 12 (16.4) |
| PDE5 inhibitorsa | 3 (4.1) | 4 (6.2) |
| Sex hormones | ||
| Testosteronea | ||
| Mean (SD), ng/dL | 225.0 (56.8) | 252.3 (56.4) |
| No. (%) | ||
| ≤200 ng/dL | 23 (31.5) | 12 (18.5) |
| >200 ng/dL | 50 (68.5) | 53 (81.5) |
| Free testosterone, mean (SD), pg/mL | 59.1 (18.2) | 67.6 (22.9) |
| Dihydrotestosterone, mean (SD), ng/dL | 22.7 (16.0) | 21.6 (10.0) |
| Estradiol, mean (SD), pg/mL | 19.7 (5.2) | 21.2 (6.2) |
| Sex hormone–binding globulin, mean (SD), μg/mL | 3.4 (1.7) | 3.3 (1.5) |
Abbreviations: ACC/AHA, American College of Cardiology/American Heart Association; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); IQR, interquartile range; PDE5, phosphodiesterase type 5.
SI conversion factors: To convert testosterone to nanomoles per liter, multiply by 0.0347; estradiol to picomoles per liter, multiply by 3.671; and sex hormone–binding globulin to nanomoles per liter, multiply by 8.896.
Factor used to balance the treatment assignment using the minimization procedure.
Includes Asian, North American Indian/Alaska Native, multiracial, and other.
The 10-year risk of heart disease or stroke by the ACC/AHA risk calculator (http://www.cvriskcalculator.com).24
Higher scores indicate more coronary artery calcium.