Table 2—

Effects of tadalafil on efficacy variables

Change in efficacy end points*Treatment group
PlaceboTadalafil 10 mgPTadalafil 20 mgP
n717372
ΔIIEF EF domain0.16.4<0.0017.3<0.001
 By HbA1c level0.5068§
  Good: <7.0%−1.09.78.3
  Fair: 7.0–9.5%−0.96.06.7
  Poor: >9.5%3.93.88.3
 By concomitant antihypertensive medication use<0.001
  Yes−1.83.99.5
  No1.17.95.5
ΔSEP-Q2 (%)−4.122.2<0.00122.6<0.001
 By HbA1c level0.649§
  Good: <7.0%−13.721.030.6
  Fair: 7.0–9.5%−3.324.121.0
  Poor: >9.5%3.713.021.2
 By concomitant antihypertensive medication use0.004
  Yes−4.216.433.8
  No−4.125.813.4
ΔSEP-Q3 (%)1.928.4<0.00129.1<0.001
 By HbA1c level0.793¶
  Good: <7.0%4.435.734.2
  Fair: 7.0–9.5%−1.727.828.8
  Poor: >9.5%9.721.126.8
 By concomitant antihypertensive medication use0.085
  Yes−4.521.931.9
  No5.432.526.9
  • Data are % unless otherwise indicated.

  • *

    * Changes from baseline to end point in mean erectile function domain scores (unitless) or in proportions (%) of “yes” responses to SEP-Q2 (“Were you able to insert your penis into your partner’s vagina? [yes/no]”) or SEP-Q3 (“Did your erection last long enough to have successful intercourse? [yes/no]”).

  • P for comparison of tadalafil 10 mg vs. placebo;

  • P for comparison of tadalafil 20 mg vs. placebo;

  • §

    § interaction P for difference in response to therapy by baseline HbA1c level;

  • interaction P for difference in response to therapy by antihypertensive medication status.