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sildenafil; specifically, this effect might be greater in sildenafil nonresponders compared with
responders or participants naïve to sildenafil or other PDE–5 treatments.
Proportion of patients with IIEF–EF ≥ 26. This outcome was reported for three trials. 184,201,203
The pooled estimate of relative risk in the meta-analysis based on the results of these three trials
indicated that a higher proportion of participants reached at least 26 on the IIEF score in the
vardenafil group compared with the placebo group (RR = 4.05, 95 percent CI: 2.74–6.01 )
(Figure 43).
Harms.
Proportion of patients with any adverse events (all-cause). The result of this meta-analysis,
based on six trials, 182,184,189,191,200,203 showed a statistically significantly higher incidence of
adverse events from any cause among participants who received vardenafil compared with those
who received placebo (RR = 1.61, 95 percent CI: 1.40–1.87) (Figure 44). (Note: “favors” in
forest plots refers to increased frequency of the event for the respective treatment arm, regardless
of desirability of the event)
Patients who withdrew due to adverse events. This meta-analysis incorporated data from 10
trials. 182,184,189,191,192,194,197,198,201,203 Although the pooled effect estimate of RR indicated a 29
percent increase in the rate of withdrawal due to adverse events for patients treated with
vardenafil relative to those treated with placebo, the observed difference in rates between the two
treatment groups was not statistically significant (RR = 1.29, 95 percent CI: 0.78–2.13) (Figure
45).
Patients with serious adverse events (all-cause). This meta-analysis incorporated 9
trials. 182,184,191,192,197,198,200,201,203 Although the pooled effect estimate of RR indicated a 34 percent
increase in the risk of experiencing at least one serious adverse event among patients treated with
vardenafil relative to those treated with placebo, the observed difference in the rates between the
two treatment groups was not statistically significant (RR = 1.34, 95 percent CI: 0.76–2.36)
(Figure 46).
Patients with headache (all-cause). This meta-analysis incorporated the results of nine
trials. 182,191,192,194,197,198,200,203,213 According to the pooled estimate, the use of vardenafil was
associated with a significantly increased risk of headache relative to the use of placebo (RR =
4.10, 95 percent CI: 2.56–6.57) (Figure 47).
Proportion of patients with flushing (all-cause). This meta-analysis included nine trials. 182,
191,192,194,197,198,200,201,203 Patients treated with vardenafil patients were at a statistically significant
increased risk of flushing compared with patients treated with placebo (RR = 10.22, 95 percent
CI: 5.26–19.87). The magnitude of the pooled RR may have been an overestimate of the true RR
because low counts observed in the placebo arms which would cause some instability and
inflation of individual estimates of RR (Figure 48).
Proportion of patients with dyspepsia (all-cause). This meta-analysis included six trials, 182,191,
192,194,197,198 the outcome of dyspepsia was not ascertainable for five trials. 184,189,200,201,203 Patients
who received vardenafil were at a statistically significantly higher risk of dyspepsia compared
with those who received placebo (RR = 6.58, 95 percent CI: 2.61–16.60) (Figure 49).
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