Table 2.
Proportion of patients achieving minimal clinically important difference (change ≥ 4 from baseline to end point) at end point (week 12, last observation carried forward) in the international index of erectile function erectile function domain*
| Variable | PRN
|
OAD
|
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low dose (10 mg; n = 527)
|
High dose (20 mg; n = 1,816)
|
Low dose (2.5 mg; n = 96)
|
High dose (5 mg; n = 617)
|
|||||||||
| N | n | OR (TAD vs PBO) | N | n | OR (TAD vs PBO) | N | n | OR (TADA vs PBO) | N | n | OR (TAD vs PBO) | |
| Age (y) | ||||||||||||
|
| ||||||||||||
| <50 | 139 | 96 | 3.34§ | 597 | 456 | 4.24§ | 21* | 13 | 3.00† | 191 | 151 | 5.27§ |
|
| ||||||||||||
| 50–64 | 219 | 146 | 5.20§ | 813 | 613 | 6.72§ | 35* | 22 | 4.25§ | 299 | 207 | 4.65§ |
|
| ||||||||||||
| ≥65 | 128 | 82 | 4.99§ | 298 | 217 | 6.56§ | 37* | 16 | 2.47 | 103 | 68 | 6.22§ |
|
| ||||||||||||
| Baseline BMI (kg/m2) | ||||||||||||
|
| ||||||||||||
| <30 | 408 | 279 | 4.68§ | 1,368 | 1,027 | 5.70§ | 71 | 42 | 3.84§ | 427 | 314 | 5.64§ |
|
| ||||||||||||
| ≥30 | 78 | 45 | 3.47§ | 341 | 260 | 5.73§ | 22* | 9 | 1.37 | 166 | 112 | 3.62§ |
|
| ||||||||||||
| Baseline diabetes | ||||||||||||
|
| ||||||||||||
| Yes | 88 | 51 | 3.93§ | 372 | 246 | 4.41§ | 17* | 9 | 3.78† | 93 | 55 | 3.78§ |
|
| ||||||||||||
| No | 398 | 273 | 4.61§ | 1,337 | 1,041 | 6.30§ | 76 | 42 | 2.99§ | 500 | 371 | 5.34§ |
|
| ||||||||||||
| Baseline cardiovascular disorder | ||||||||||||
|
| ||||||||||||
| Yes | 174 | 100 | 3.32§ | 596 | 434 | 5.51§ | 47* | 26 | 3.70§ | 244 | 163 | 5.15§ |
|
| ||||||||||||
| No | 312 | 224 | 5.36§ | 1,113 | 853 | 5.79§ | 46* | 25 | 2.31† | 349 | 263 | 4.88§ |
|
| ||||||||||||
| Baseline hypertension | ||||||||||||
|
| ||||||||||||
| Yes | 127 | 68 | 2.80§ | 477 | 345 | 5.35§ | 38* | 18 | 2.84† | 193 | 126 | 4.90§ |
|
| ||||||||||||
| No | 359 | 256 | 5.36§ | 1,232 | 942 | 5.87§ | 55* | 33 | 3.04§ | 400 | 300 | 5.00§ |
|
| ||||||||||||
| Baseline hyperlipidemia | ||||||||||||
|
| ||||||||||||
| Yes | 59† | 42 | 6.05§ | 193 | 141 | 5.77§ | 23* | 12 | 3.64† | 105 | 72 | 5.92§ |
|
| ||||||||||||
| No | 427 | 282 | 4.30§ | 1,516 | 1,146 | 5.69§ | 70 | 39 | 2.86§ | 488 | 354 | 4.70§ |
|
| ||||||||||||
| Smoking | ||||||||||||
|
| ||||||||||||
| Yes | 144 | 100 | 4.32§ | 455 | 346 | 4.94§ | 11* | 5 | 1.04 | 81 | 58 | 2.44† |
|
| ||||||||||||
| No | 342 | 224 | 4.50§ | 1,247 | 937 | 6.02§ | 82 | 46 | 3.50§ | 210 | 148 | 5.57§ |
|
| ||||||||||||
| Alcohol use | ||||||||||||
|
| ||||||||||||
| Yes | 286 | 197 | 5.07§ | 893 | 681 | 6.28§ | 66 | 34 | 2.95§ | 235 | 172 | 5.62§ |
|
| ||||||||||||
| No | 200 | 127 | 3.87§ | 804 | 597 | 5.20§ | 27* | 17 | 2.94† | 114 | 79 | 3.03§ |
BMI = body mass index; N = number of subjects with baseline and end-point results; n = number of subjects achieving minimal clinically important difference at study end point; PBO = placebo; OAD = once a day; OR = odds ratio; PRN = as needed; TAD = tadalafil.
Fewer than 64 patients in subgroup.
P ≤ .05.
P ≤ .001.