Beste apotheek van Nederland

Clinically homogenous groups of patients. Seven trials included ED patients who
additionally presented with diabetes Types I and II, 181,204,205 nerve-sparing retropubic
prostatectomy, 183 renal transplantation, 206 untreated mild major depression, 199 or arterial
hypertension. 196 Only three trials 181,204,205 including diabetic patients were potentially suitable for
meta-analysis.
Efficacy. Meta-analyses for efficacy outcomes in diabetes patients were not performed in
view of missing qualitative or quantitative information (i.e., the outcome was not reported at all
or no numerical data were given on measures of variability).
Harms.
Patients with serious adverse events (all-cause). This meta-analysis included results from
three trials. 181,204,205 There was a statistically nonsignificant finding of a 40 percent increased risk
of a serious adverse event in patients who received vardenafil versus those who received placebo
(RR = 1.40, 95 percent CI: 0.59–3.29) (Figure 50).
Patients who withdrew due to adverse events. This meta-analysis included results from three
trials of patients with diabetes. 181,204,205 The difference in the withdrawal rates resulting from
adverse events between these patients in vardenafil and placebo groups was not statistically
significant (RR = 1.80, 95 percent CI: 0.66–4.91) (Figure 51).
Dose-response effect of vardenafil (20 mg versus 10 mg). There were 10 trials with two or
more dose-specific arms of vardenafil. 181,183,189,190,192-195,198,205 The analysis in this section
excluded trials of distinct clinical groups of patients 181,183,205 and crossover trials. 193,195 Therefore,
five potentially eligible trials remained for the analyses. 189,190,192,194,198 Meta-analysis could be
performed with respect to only one efficacy outcome, the IIEF “EF” domain endpoint score. For
other efficacy outcomes (IIEF–Q3/Q4, SEP–Q2/Q3) quantitative data necessary for metaanalysis
were missing. 189,190,192,198
Efficacy.
Mean IIEF “EF” domain score. This meta-analysis incorporated two trials. 190,194 The estimate
of pooled mean difference for the IIEF “EF” domain score observed between the two groups of
patients at weeks 12–104 was not statistically significant (WMD = 0.92, 95 percent CI: -0.03 to
1.87) (Figure 52).
Proportion of patients with improved erection (GAQ–Q1). This meta-analysis incorporated
results of four trials. 189,190,192,194 The proportion of patients with improved erection at week 12
was similar in the 20 mg and 10 mg vardenafil treatment groups (RR = 1.03, 95 percent CI:
0.99–1.08) (Figure 53).
Harms.
Proportion of patients with any adverse events (all cause). The result of this meta-analysis,
incorporating two trials, 189,190 indicated a marginally statistically significant increase in risk for
any adverse event for patients treated with 20 mg vardenafil compared with those treated with 10
mg vardenafil (RR = 1.15, 95 percent CI: 1.06–1.25) (Figure 54).
Proportion of patients with serious adverse events (all cause). This meta-analysis was based
on results of three trials. 190,192,198 The occurrence of serious adverse events could not be
ascertained for two trials. 189,194 The pooled estimate of relative risk indicated that the risk of
developing any serious adverse event did not differ between the groups of patients receiving 20
mg and 10 mg doses of vardenafil (RR = 1.02, 95 percent CI: 0.37–2.82) (Figure 55).
Patients who withdrew due to adverse events. This meta-analysis included five
trials. 189,190,192,194,198 The difference in withdrawal rates resulting from adverse events observed
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