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. Author manuscript; available in PMC: 2017 May 2.
Published in final edited form as: J Sex Med. 2016 May;13(5):860–875. doi: 10.1016/j.jsxm.2016.02.171

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.