Beste apotheek van Nederland

investigated. 78-91,93-99,101,102,104,105,107-111,115,122,123,125,126,128,130-135,137,138,142,143,146,147,
149,151,156,160,164,168, 171,175
The quantitative analysis was considered separately for two groups of trials (n = 62), as
follows:
Trials conducted in clinically heterogeneous groups of participants with ED (with no
established specific organic cause) (n = 34)
Trials conducted in clinically homogenous groups of participants with ED (participants
diagnosed additionally with specific clinical conditions (2a-2e) (n = 28)
The 34 clinically heterogenous trials were potentially eligible for the meta-analyses (24 parallelarm
and 10 crossover).
80,82,83,85-90,95-97, 105, 110,111,122,125,126,130,132,134,135,137,138,142,146, 149,151,156, 166,171
None of the 10 crossover trials 85,89,105, 130,132, 134,146,149 however, were incorporated in the metaanalyses
(pre-crossover phase data were not reported), leaving 24 trials for further
consideration. 80,82,83,86-88,90,95-97,110,111,122,125,126,135,137,138,142,151,156,166,171
Efficacy. Absolute endpoint mean IIEF “EF” domain score. The meta-analysis was based on
two trials. 88,126 The pooled estimate of mean difference was 6.39 (95 percent CI: 2.89–9.90),
indicating a statistically significant improvement in the mean IIEF “EF” domain score for
participants receiving sildenafil (any dose) compared with those receiving placebo (Figure 3).
Absolute endpoint mean IIEF–Q3/Q4 scores. The two meta-analyses yielded statistically
significant pooled estimates of mean differences for both IIEF–Q3 (mean difference 1.46, 95
percent CI: 1.26–1.65) and IIEF–Q4 (mean difference 1.52, 95 percent CI: 1.21–1.82). Thus, the
use of sildenafil was associated with statistically significant improvements with respect to
penetration and erectile maintenance frequency (Figures 4–5).
Proportion of participants with improved erection (GEQ–Q1). This meta-analysis included
17 trials including two trials reported in Young et al. (2002). 80,82,83,86-88,90,95,97,125,
126,137,138,142,151,156 The pooled estimate of relative risk (RR) of 2.61 (95 percent CI: 2.34–2.91)
indicated a greater proportion of participants experiencing improved erection (i.e., those who
answered “yes” to GEQ–Q1) in the sildenafil than in the placebo treatment groups (Figure 6).
Sensitivity analysis was performed with respect to the duration of sildenafil treatment. The
duration of sildenafil treatment in 11 trials lasted 12 weeks. 80,83,87,97,125,126,137,138,142,151,156 The
duration of treatment in the remaining trials was 6 weeks, 90 (studies a and b) 8 weeks, 82 16
weeks, 95 and 26 weeks. 86,88 The meta-analysis restricted to trials with 12-week treatment did not
appreciably affect the magnitude of the effect estimate and the degree of I 2 test for heterogeneity,
which decreased from 51.9 percent to 50.0 percent.
Harms. 24 trials (including trials with participants with psychogenic ED), 96,110 were
80,82,83,86-88,90,95-97,110,111,122,125,126,135,137, 138,142,
considered for the meta-analysis of adverse events. 151,156,166,171 (note that “favors” in forest plots refers to increased frequency of the event for the
respective treatment arm, regardless of the desirability of the event).
Proportion of participants with at least one adverse event (all cause). The pooled estimate of
RR suggested that participants randomly assigned to receive sildenafil were at a higher risk of
developing any all-cause adverse event than those receiving placebo (RR = 1.51, 95 percent CI:
1.32–1.72) (Figure 7).
Proportion of participants with at least one adverse event (treatment-related). This metaanalysis
incorporated 11 trials. 80,82,83,87,90,97,125,135,137,156 The meta-analysis yielded a pooled RR of
2.56 (95 percent CI: 2.17–3.03), indicating that participants randomly assigned to receive
sildenafil were at a higher risk of developing any treatment-related adverse event than those
receiving placebo (Figure 8).
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