Table 2. Patient demographics and baseline characteristics.
| Characteristic |
Total |
Placebo |
10 mg Tadalafil |
20 mg Tadalafil |
P-value |
|---|---|---|---|---|---|
| (N = 1 046) | (N = 351) | (N = 185) | (N = 510) | ||
| Mean age, years (range) | 53 (22–82) | 53 (22–81) | 55 (29–82) | 52 (24–79) | 0.069 |
| Age > 65, n (%) | 175 (17) | 55 (16) | 49 (26) | 71 (14) | < 0.001 |
| Ethnicity, n (%) | < 0.001 | ||||
| Caucasian | 1 (0) | 0 (0) | 0 (0) | 1 (0) | |
| East/Southeast Asian | 917 (88) | 310 (88) | 184 (99) | 423 (83) | |
| West Asian | 127 (12) | 41 (12) | 1 (1) | 85 (17) | |
| Other | 1 (0) | 0 (0) | 0 (0) | 1 (0) | |
| Mean body mass index, kg m−2 (range) | 25.0 (13.8–50.4) | 25.0 (16.9–37.5) | 25.0 (17.2–50.4) | 25.1 (13.8–38.5) | 0.956 |
| Smokers, n (%) | 354 (34) | 114 (32) | 74 (40) | 166 (33) | 0.232 |
| Prior sildenafil use, n (%) | 483 (46) | 162 (46) | 61 (33) | 260 (51) | < 0.001 |
| Duration of ED ≥ 12 months, n (%) | 920 (88) | 321 (91) | 171 (92) | 428 (84) | < 0.001 |
| ED etiology, n (%)a | 0.063 | ||||
| Psychogenic | 180 (17) | 72 (21) | 23 (12) | 85 (17) | |
| Organic | 517 (49) | 169 (48) | 87 (47) | 261 (51) | |
| Mixed | 349 (33) | 110 (31) | 75 (41) | 164 (32) | |
| Erectile dysfunction severity, n (%)b,c | 0.686 | ||||
| Mild (IIEF: 17–30) | 408 (39) | 134 (38) | 67 (36) | 207 (41) | |
| Moderate (IIEF: 11–16) | 344 (33) | 115 (33) | 59 (32) | 170 (33) | |
| Severe (IIEF: 1–10) | 294 (28) | 102 (29) | 59 (32) | 133 (26) | |
| Medical history, n (%) | |||||
| Cardiovascular disease | 294 (28) | 91 (26) | 47 (25) | 156 (31) | 0.218 |
| Coronary artery disease | 31 (3) | 14 (4) | 4 (2) | 13 (3) | 0.368 |
| Depression | 8 (1) | 2 (1) | 2 (1) | 4 (1) | 0.810 |
| Diabetes mellitus | 273 (26) | 93 (26) | 22 (12) | 158 (31) | < 0.001 |
| Hypertension | 259 (25) | 80 (23) | 38 (21) | 141 (28) | 0.092 |
| Hyperlipidaemia | 83 (8) | 32 (9) | 12 (6) | 39 (8) | 0.533 |
Abbreviations: ED, erectile dysfunction; IIEF, International Index of Erectile Function; N, number of randomized patients per treatment group; n, number of patients.
a
The cause of erectile dysfunction was defined subjectively according to each investigator's clinical opinion.
b
Erectile dysfunction severity categories were based on a modified version of the definition by Cappelleri et al. 18.
c
The subsequent assessment of erectile function by the IIEF at baseline indicated that a small percentage of patients had an erectile function domain score in the normal range (26–30).