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Table 4 Impact of patient-characteristics and comorbidities on EF and treatment-satisfaction during tadalafil OaD treatment (N = 778; MMRM)

From: Tadalafil 5 mg once daily for the treatment of erectile dysfunction during a 6-month observational study (EDATE): impact of patient characteristics and comorbidities

  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
  1. BPH benign prostatic hyperplasia, CI confidence interval, CVD cardiovascular disease, ED erectile dysfunction, EDITS Erectile Dysfunction Inventory of Treatment Satisfaction, IIEF International Index of Erectile Function, LS mean least-square mean, MMRM Mixed Model for Repeated Measures, N number of patients, n number of patients included in the model, OaD once a day, PDE5-I phosphodiesterase type 5 inhibitor
  2. aEDITS scores at baseline were collected only in patients pretreated with PDE5-I
  3. *95 % confidence interval does not include zero and p-value statistically significant (<0.05)