Table 4 Impact of patient-characteristics and comorbidities on EF and treatment-satisfaction during tadalafil OaD treatment (N = 778; MMRM)
IIEF domain scores (n = 646) | EDITS total score (n = 165)a | |||||
|---|---|---|---|---|---|---|
Erectile function | Orgasmic function | Sexual desire | Intercourse satisfaction | Overall satisfaction | ||
Change from baseline at Visit 2 | ||||||
LS mean | +6.17* | +1.06* | +0.38* | +2.70* | +2.26* | +14.17* |
95 % CI | +4.82 to +7.51 | +0.54 to +1.57 | +0.03 to +0.74 | +2.02 to +3.38 | +1.77 to +2.75 | +1.00 to +27.34 |
p-value | <0.001 | <0.001 | 0.034 | <0.001 | <0.001 | 0.035 |
Change from baseline at Visit 3 | ||||||
LS mean | +7.11* | +1.36* | +0.48* | +3.18* | +2.56* | +14.83* |
95 % CI | +5.76 to +8.47 | +0.83 to +1.88 | +0.12 to +0.84 | +2.48 to +3.87 | +2.06 to +3.06 | +1.64 to +28.02 |
p-value | <0.001 | <0.001 | 0.010 | <0.001 | <0.001 | 0.028 |
Fixed effects | ||||||
Age group (18–65 vs >65 years) | ||||||
LS mean effect | +0.45 | −0.11 | +0.15 | +0.20 | +0.04 | +11.25* |
95 % CI | −0.98 to +1.88 | −0.66 to +0.44 | −0.23 to +0.53 | −0.53 to +0.92 | −0.49 to +0.56 | +2.96 to +19.54 |
p-value | 0.539 | 0.707 | 0.444 | 0.592 | 0.896 | 0.008 |
PDE5-I pretreatment (yes vs no) | ||||||
LS mean effect | −2.13* | −0.69* | −0.10 | −0.93* | −0.74* | +7.11 |
95 % CI | −3.33 to −0.94 | −1.15 to −0.23 | −0.41 to +0.22 | −1.54 to −0.33 | −1.17 to −0.30 | −12.5 to +26.74 |
p-value | <0.001 | 0.003 | 0.548 | 0.003 | 0.001 | 0.475 |
ED etiology | ||||||
Psychogenic vs mixed | ||||||
LS mean effect | −0.25 | +0.17 | +0.04 | −0.03 | +0.06 | −4.69 |
95 % CI | −1.75 to +1.26 | −0.41 to +0.75 | −0.35 to +0.44 | −0.79 to +0.74 | −0.49 to +0.62 | −15.2 to +5.79 |
p-value | 0.747 | 0.558 | 0.825 | 0.944 | 0.817 | 0.378 |
Organic vs mixed | ||||||
LS mean effect | −0.63 | −0.17 | −0.13 | −0.44 | −0.39 | −1.70 |
95 % CI | −1.97 to +0.71 | −0.69 to +0.34 | −0.48 to +0.23 | −1.12 to +0.24 | −0.88 to +0.10 | −9.31 to +5.92 |
p-value | 0.359 | 0.507 | 0.479 | 0.205 | 0.116 | 0.661 |
ED severity (investigator assessment) | ||||||
Mild vs moderate | ||||||
LS mean effect | −2.00* | −0.06 | −0.45* | −0.56 | −0.97* | −4.52 |
95 % CI | −3.54 to −0.46 | −0.66 to +0.53 | −0.86 to −0.05 | −1.35 to +0.22 | −1.53 to −0.41 | −16.4 to +7.35 |
p-value | 0.011 | 0.833 | 0.029 | 0.156 | <0.001 | 0.453 |
Severe vs moderate | ||||||
LS mean effect | +0.99 | +0.93* | −0.21 | +0.30 | +0.30 | +3.99 |
95 % CI | −0.37 to +2.34 | +0.41 to +1.45 | −0.57 to +0.15 | −0.39 to +0.99 | −0.20 to +0.80 | −3.37 to +11.35 |
p-value | 0.154 | <0.001 | 0.260 | 0.395 | 0.237 | 0.285 |
Comorbidities | ||||||
BPH (yes vs no) | ||||||
LS mean effect | −2.77* | −0.87* | −0.72* | −1.08 | −0.52 | +5.78 |
95 % CI | −4.98 to −0.55 | −1.73 to −0.02 | −1.30 to −0.13 | −2.21 to +0.04 | −1.34 to +0.29 | −8.38 to +19.94 |
p-value | 0.014 | 0.044 | 0.017 | 0.058 | 0.206 | 0.421 |
Diabetes (yes vs no) | ||||||
LS mean effect | +2.28* | +0.81* | +0.06 | +0.92* | +0.81* | +5.62 |
95 % CI | +0.64 to +3.92 | +0.17 to +1.44 | −0.38 to +0.50 | +0.09 to +1.76 | +0.20 to +1.41 | −3.62 to +14.71 |
p-value | 0.007 | 0.013 | 0.787 | 0.030 | 0.009 | 0.223 |
CVD (yes vs no) | ||||||
LS mean effect | −1.78 | −1.93 | 0 | −0.97 | −0.49 | +3.48 |
95 % CI | −7.53 to +3.96 | −4.14 to +0.29 | −1.52 to +1.52 | −3.88 to +1.95 | −2.60 to +1.62 | −2.70 to +33.97 |
p-value | 0.542 | 0.088 | 0.997 | 0.515 | 0.648 | 0.822 |
Hypertension (yes vs no) | ||||||
LS mean effect | +1.62 | +1.91 | +0.29 | +0.77 | −0.04 | −1.33 |
95 % CI | −4.14 to +7.39 | −0.31 to +4.13 | −1.24 to +1.81 | −2.16 to +3.69 | −2.15 to +2.07 | −31.7 to +29.00 |
p-value | 0.580 | 0.091 | 0.711 | 0.606 | 0.969 | 0.931 |
Dyslipidemia (yes vs no) | ||||||
LS mean effect | −0.05 | −0.19 | −0.31 | +0.02 | −0.17 | −4.26 |
95 % CI | −1.61 to +1.51 | −0.79 to +0.41 | −0.72 to +0.11 | −0.78 to +0.81 | −0.74 to +0.41 | −13.1 to +4.60 |
p-value | 0.946 | 0.528 | 0.145 | 0.966 | 0.568 | 0.343 |