Beste apotheek van Nederland

escalation for another 6 weeks) and, compared with those receiving placebo, had a statistically
significant greater mean change in the IIEF “EF” domain score at 6 and 12 weeks of treatment
(12 weeks: 7.7 versus 1.4, p < 0.001). Furthermore, results of two trials 235,238 indicated that
patients receiving even lower doses of tadalafil (2.5 mg and 5 mg) compared with those in the
placebo group had greater statistically significant improvements in erectile functioning with
respect to the mean score changes in the IIEF “EF” domain (19.1–20.8 versus 14.6, p < 0.001)
and the per-patient proportion of “yes” answer to SEP Q2–3 (for Q2: 65.3–70.7 versus 51.1, p <
0.001 and for Q3: 50.0–57.0 versus 31.3, p < 0.001). 235 Compared with the placebo group, in
both tadalafil dose-groups there was a significantly greater proportion of patients who answered
“yes” to GAQ1–2 (5 mg: 70.7–72.8 percent, versus 2.5 mg: 58.5–62.8 percent, versus placebo:
23.9–26.1 percent). 235
Furthermore, patients who received tadalafil compared with those who received placebo had
statistically significant greater improvements in erectile function as measured by the mean IIEF
score change from baseline to endpoint for the IIEF “Intercourse Satisfaction” and “Overall
Satisfaction” domains. 216,217,223,224,226,227,229,234-240,243
In several trials, there was a statistically significant greater mean per-patient percentage of
successful intercourse attempts measured at different intervals after dosing in tadalafil arms
compared with placebo arms. 217,219,220,224,225,230
The mean overall EDITS score in patients who received tadalafil showed a statistically
significant improvement compared with that in patients who received placebo. 217,222,223 The mean
overall EDITS score values in tadalafil arms across the trials were 66.8, 217,243 58.0, 222 and 77. 223
The corresponding values for placebo arms in these trials were 35.6, 34.0, and 46.0, respectively.
In one of these trials, 223 patients treated with tadalafil had a median EDITS score of 84,(95
percent CI: 80–86) as opposed to those treated with placebo, who had a median EDITS score of
41 (95 percent CI: 32–59). The difference between the two median scores was statistically
significant (p <0.001).
The mean change measured on individual IIEF Q3–4 scores (Q3, penetration ability; Q4,
maintenance ability) was reported in 8 trials (out of the 23 placebo-controlled trials), 217,220,226,234­
237,240 all of which showed highly statistically significant improvements for patients treated with
tadalafil patients compared with those treated with placebo (p < 0.001).
The authors of one trial 218 showed that after a 4-week therapy, patients treated with tadalafil
experienced greater improvements in endothelial function as measured by brachial artery flowmediated
dilation (FMD) than patients treated with placebo. For example, in the tadalafil arm,
the mean change in FMD from baseline to the end point was statistically significant (9.3 versus
4.2 percent, p < 0.01), whereas in the placebo arm the mean FMD did not change (4.1 versus 4.3,
p >0.05).
Four studies examined the efficacy according to severity of ED. 216,235,237,238 The number of
patients achieving normal scores in IIEF–EF were higher in mild ED compared with moderate or
severe ED. 216,235,237,238 Similarly higher end scores of IIEF–EF were achieved in patients with
mild compared with moderate or severe ED. 216,235,237,238 (Table 11)
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