Beste apotheek van Nederland

Given that the fourth trial 79 looked at ED patients who had depression but were not being treated
with antidepressants at the time of their enrollment (this being one of the exclusion criteria),
SSRI use could not be considered the cause of the ED, and the trial was therefore not combined
with the other three for meta-analysis. 91,115,167
The results for the following efficacy outcomes (i.e., numerical effect estimates and standard
deviations [SDs]) were ascertained from the three trials: percentage of successful intercourse
attempts, 115,167 patients with improved erection (GEQ–Q1), 115,167 and mean IIEF–Q3/Q4
score. 91,115 The mean IIEF–Q3/Q4 scores and the corresponding SDs were ascertained
graphically from one trial. 115 Separate meta-analyses for these efficacy outcomes are presented
(see Figures 16–19). No meta-analysis for adverse events could be performed, due to a lack of
sufficient detail for the adverse events definitions provided in the trials. Note that one trial 91
included younger patients (mean: 45, range 18–55 years) compared with the other trial (mean:
53, range 24–75 years). 115
Efficacy. Percentage of successful intercourse attempts, proportion of patients with improved
erection, mean IIEF–Q3/Q4 score.
The pooled effect estimates of meta-analyses based on participants with depression were
statistically significant, favoring the use of sildenafil over placebo with respect to: increasing the
percentage of successful intercourse attempts (RR = 2.44, 95 percent CI: 1.87–3.18); improving
erection, GEQ–Q1 (RR = 2.40, 95 percent CI: 1.87–3.06); improving penile penetration ability,
IIEF–Q3 (mean difference 1.26, 95 percent CI: 0.82–1.70); and improving erectile maintenance
frequency, as assessed by IIEF–Q4 (mean difference 1.48, 95 percent CI: 0.96–1.99) (Figures
18–21).
Two sildenafil versus placebo trials conducted in participants with chronic congestive heart
failure (CHF) were potentially combinable. 102,109 However, no meta-analysis was performed in
view of the fact that the only common outcome reported in both trials was the mean IIEF “EF”
domain score, for which numerical values of the measures of variability—SD or standard error
(SE) could not be ascertained. One of the trials 102 used a crossover design; it reported precrossover
results graphically, without presenting numeric measures of the variability. In the same
trial, no participant had any adverse events; therefore, no meta-analysis for adverse events was
performed.
There were two trials that looked at patients with chronic renal failure on peritoneal dialysis.
Although they were both eligible for meta-analysis (with respect to the mean IIEF “EF” domain
score), 108,123 they could not be pooled in view of a lack of complete numerical data (i.e., a SD or
SE) in one of the trials. 108 A meta-analysis for adverse events was also not feasible, since in one
of the trials 108 only one event was observed.
Meta-analysis was possible for sildenafil versus placebo trials involving hypertensive
patients using multiple antihypertensive drugs (i.e., two or more different classes). 143,147 The
meta-analyses were performed for efficacy outcomes (i.e., mean IIEF–Q3/Q4, GEQ–Q1,
percentage of successful intercourse attempts) as well as all-cause and treatment-related specific
adverse events (headache, flushing, and dyspepsia) (Figures 22–29).
Efficacy. Mean IIEF–Q3/Q4, GEQ–Q1, percentage of successful intercourse attempts.
The mean IIEF–Q3/Q4 scores with respective SDs were ascertained from the reports of both
trials, as well as for GEQ–Q1, along with the percentage of successful intercourse attempts (see
Figures 20–23). The pooled effect estimates indicate a statistically significant improvement in
patients receiving sildenafil in comparison with those receiving placebo with respect to:
improving penile penetration ability, IIEF–Q3 (mean difference 1.09, 95 percent CI: 0.59–1.58);
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