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improved erections was higher in participants who received 20 mg compared with those who
received 10 mg of vardenafil (72 versus 57 percent, p < 0.03).
In one trial, 193 the difference in the mean change of the duration of penile rigidity (>60
percent) between the 20 mg and 40 mg doses of vardenafil was not statistically significant (42.9
versus 49.3).
Quantitative Synthesis - Meta-Analysis of Trials
Series of meta-analyses were performed using efficacy and harms data obtained from the
reports of 21 trials 180-184,189,191-201,203-206 that were conducted in:
1) Clinically heterogenous groups of patients
2) Clinically homogenous groups of patients
Clinically heterogenous groups of patients - vardenafil (any dose: 5 mg, 10 mg, 20 mg,
40 mg) versus placebo. The analyses presented in this section did not include 10 trials for the
following reasons: distinct clinical groups of patients (e.g. those with diabetes, prostatectomy,
renal transplant, depression, hypertension); 181,183,196,199,204-206 crossover design in which no precrossover
data were reported); 193,195 and lack of measurement or reporting of relevant clinical
outcomes. 180,195 Thus, there remained 11 trials that were potentially eligible for metaanalysis.
182,184,189,191,192, 194,197,198,200,201,203
Efficacy. Mean IIEF “EF” domain score.
This meta-analysis incorporated three trials 182,194,200 in which the pooled estimate of mean
difference at 12 weeks after randomization was 7.35 (95 percent CI: 6.43–8.27), indicating a
statistically significant improvement in the mean IIEF “EF” domain score in participants on
vardenafil (any dose) compared with those on placebo. (Figure 38)
Mean per-patient proportion of successful intercourse attempts (SEP–Q2). This metaanalysis
was based on two trials of flexible vardenafil dose. 184,200 The estimated mean difference
between vardenafil- and placebo-treated participants after 12 weeks of treatment was statistically
significant in favor of vardenafil (WMD = 27.59, 95 percent CI: 17.06–38.11). One of the
trials 184 was restricted to patients who were nonresponders to previous treatment with sildenafil.
This difference between the populations of the two trials might have led to the high degree of
statistical heterogeneity that was found (I 2 = 61 percent) (Figure 39).
Mean per-patient proportion of successful intercourse attempts (SEP–Q3). This meta-analysis
was based on two trials 184,200 and yielded a statistically significant pooled estimate of mean
difference for erectile maintenance (SEP–Q3) (WMD = 33.19, 95 percent CI: 26.04–40.33),
indicating that the treatment with vardenafil was associated with greater improvements in erectile
maintenance frequency compared with placebo. (Figure 40)
Proportion of patients with improved erection (GAQ–Q1). Two separate meta-analyses were
performed (Figures 41–42). The first incorporated results of 9 trials (Figure 41). 182,184,189,191,192,
194,200,201,203 There was a statistically significantly higher rate of improvement at week 12 in
erection among participants who received vardenafil compared with those who received placebo
(RR = 2.50, 95 percent CI: 2.19–2.86). The trial that included only participants who did not
respond to sildenafil 184 had an outlying value of larger effect estimate size (RR = 4.1), leading to
a high degree of statistical heterogeneity across the trials (I 2 = 51.5). The second meta-analysis,
which did not incorporate the trial of sildenafil nonresponders 184 (see Figure 42), yielded a
substantially lower degree of heterogeneity (I 2 = 3.7) and a pooled RR of 2.38 (95 percent CI:
2.16–2.61). The vardenafil effect size may have been modified by the previous response to
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