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higher dose. In one multicenter North American study, for example, after 26 weeks of treatment
with 5 mg, 10 mg, or 20 mg of vardenafil or placebo 19, 33, 42 and 7 percent of patients,
respectively, experienced at least one adverse event. 192 In a trial of similar design of 12 weeks’
duration, these proportions were 57, 63, 74, and 52 percent, respectively. 189 The similar trend
was observed in a trial that compared 20 mg and 40 mg doses of vardenafil (47.6 versus 60.9
percent, respectively). 193 Statistical test results for these differences were not reported.
Specific adverse events. The most frequently observed adverse events in the 10 trials were
headache, flushing, dyspepsia, or rhinitis. In one trial, 190 eight and 13 patients developed visual
disturbance(s) in the 10 mg and 20 mg groups, respectively. In another trial, 189 two patients (one
patient in each 5 mg and 20 mg groups) were observed to have visual disturbances (sensory,
abnormal vision, and brightening).
Withdrawals due to adverse events. In three trials, 193,195,198 none of the patients treated with
vardenafil withdrew because of adverse events. For the remaining seven trials, 181,183,189,190,192,194,
205 the rate of withdrawals was numerically similar between treatment arms using 10 mg versus
20 mg of vardenafil. 181,183,189,190,192,194,205
Serious adverse events. There was no apparent numerical or statistically significant
difference in the occurrence of serious adverse events across the treatment arms of various doses
of vardenafil. For example, one trial reported 4, 1, and 1.4 percent of patients with at least one
serious adverse event in 5 mg, 10 mg, and 20 mg vardenafil groups, respectively. 194 In another
study, the corresponding proportions of patients with at least one serious adverse event were 5, 3,
and 4 percent. 192 Four deaths were reported during one trial; 190 one death resulted from suicide
(10 mg group), while the other three (in the 20 mg group) occurred after myocardial infarction,
coronary angioplasty, and ischemic cardiomyopathy. None of the deaths was attributed to the
effects of vardenafil.
Efficacy. In three trials, 189,192,194 at 12 weeks after randomization, a dose-related effect of
vardenafil with respect to the mean IIEF “EF” domain score was observed. Specifically, patients
in either 10 mg or 20 mg vardenafil groups had statistically significant higher mean IIEF “EF”
domain scores compared with those in the 5 mg vardenafil groups. Although for five trials 189,190,
192,194,198 the differences in the mean IIEF “EF” domain scores observed between the 10 mg and
20 mg were not statistically significant, patients receiving 20 mg of vardenafil had numerically
greater scores than those receiving 10 mg vardenafil.
In two trials, 181,205 patients treated with 20 mg had statistically significantly higher mean IIEF
“EF” domain scores compared with those treated with 10 mg vardenafil: 19.0 versus 17.1 181 and
22.9 versus 21.8. 205 In another trial, 183 the mean IIEF “EF” domain score was similar for patients
receiving 10 mg and 20 mg of vardenafil (7.7 versus 7.2, respectively).
After 12 weeks of treatment, there was a numerical increase (a statistically nonsignificant
improvement) in the mean scores of IIEF–Q3/Q4 189,194 and SEP–Q2/Q3 181,190,192 across the three
doses of vardenafil (5 mg versus 10 mg versus 20 mg), the highest being observed in the 20 mg
group. For the mean SEP–Q2/Q3, one trial 205 demonstrated a statistically significant difference
between the two doses of vardenafil (10 mg and 20 mg) in favor of the 20 mg dose.
In one trial, 194 the proportion of participants with improved erections (i.e., who answered
“yes” to GAQ–Q1) was shown to be statistically significantly greater in the 20 mg versus 5 mg
(80 versus 66 percent, p <0.01). Results from two other trials 189,192 demonstrated trends of a
numerical increase in the rate of improved erections across 5 mg, 10 mg, and 20 mg doses of
vardenafil. The highest proportion of patients with improved erections was observed in the 20
mg groups (range 80.7–86.4 percent). 189,192 In another trial, 181 the proportion of participants with
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