Beste apotheek van Nederland

In nine trials, mean EDITS scores indicated that participants exhibited a statistically
significant higher degree of treatment satisfaction after being treated with sildenafil compared
with placebo. 84,90,109,143,147,156,160,167
The beneficial effect of sildenafil use found in trials of participants with psychogenic ED 96,110
or distinct clinical subgroups (e.g. spina bifida, depression, diabetes, stable coronary artery
disease, Parkinson’s disease, congestive heart failure, multiple sclerosis, prostate cancer) 78,79,81,84,
91,93,94,98,99,101,102,104,107-109,115,123,128,131,133,143,147,160,164,165,167,168,175 were consistent with those of
other trials conducted in patients with ED of mixed etiology or those with clinically
heterogeneous conditions.
Reports of only four trials provided treatment efficacy subgroup analyses (i.e., stratification
of efficacy results) with respect to baseline severity of ED. 81,90,128 The evidence from these trials
indicated that participants with mild/moderate ED (IIEF score 11–25) after taking sildenafil
tended (statistically nonsignificant trends) to experience a greater degree of improvement in
erectile function as measured by mean scores for responses to “EF domain” and Q3–Q4 of the
IIEF questionnaire and the proportion of patients with improved erections (i.e., those who
responded “yes” to GEQ–Q1) compared with those with severe ED (IIEF ≤10).
Efficacy subgroup analyses with respect to duration of ED (0–3, 3–6, and >6 years) and age
(18–49, 50–64, and ≥65 years) were reported in two trials. 94,101 In both trials sildenafil was
shown to have improved erectile function (i.e., mean IIEF–Q3/Q4 scores and percentage of
patients who responded “yes” to GEQ–Q1) regardless of the participants’ age and the duration of
ED. The results of analyses provided for these trials did not reveal any treatment effect
modification by the above-mentioned factors. In another trial, younger age (p = 0.034) and a
shorter duration of ED (p = 0.028) were found to be predictive of a greater baseline-to-endpoint
improvement in erectile function (i.e., mean scores for the IIEF “EF” domain and “Intercourse
Satisfaction” domain). 156
Reports of five trials provided the treatment efficacy stratification analyses by ED origin (i.e.,
organic, psychogenic, and mixed). 86,88,96,134,142 The improvements in erectile function (mean
scores for IIEF “EF” domain and percentage of patients who responded “yes” to GEQ–Q1) were
observed regardless of the origin of ED in patients receiving sildenafil compared with those
receiving placebo, without identifying the origin of ED as a treatment effect modifier or
predictor.
Sildenafil dose/dosing 1 versus sildenafil dose/dosing 2. Six studies assessed the efficacy
and harm profiles for different doses (i.e., 10 mg, 25 mg, 50 mg, and 100 mg) of sildenafil
monotherapy. 78,85,86,93,96,137 Additionally, two other trials 157,161 examined and compared two
different dosage regimens of sildenafil (i.e., fixed versus flexible, different timing of
administration).
Harms. In one trial, 137 which reported the incidence of any adverse events, specifically,
events in >5 percent of participants in one or more treatment groups, the proportions of
participants experiencing at least one adverse event (due to all causes) in either the sildenafil 25
mg, 50 mg, and 100 mg treatment groups were 49, 61, and 72 percent, respectively. The
corresponding dose-specific proportions observed in another trial, 86 a were 32, 69, and 86
percent, respectively. Both trials indicated a numerically increasing trend in the incidence of any
adverse events observed with the higher dose of sildenafil. In one trial, 96 the proportion of
patients with any adverse events (i.e., events in >5 percent of patients) observed in the 25 mg and
50 mg sildenafil groups were numerically higher (59 and 45 percent, respectively) compared
with the 10 mg sildenafil group (24 percent). None of these three trials 86,96,137 reported any
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