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Qualitative Synthesis
Vardenafil (any dose, fixed dose, flexible dose) versus placebo. This section presents
results derived from 21 placebo-controlled trials that compared the efficacy and harms profile of
vardenafil (any dose) to that of placebo. 180-184,189,191-201,203-206 One trial 190 that explored a doseresponse
effect of vardenafil, without using a placebo arm, is reviewed in a later section
(vardenafil dose 1 versus vardenafil dose 2).
Harms. Of the 21 trials, harms-related data were reported in all but one. 180 Therefore, this
section describes harms reported in 20 trials. 181-184,189,191-201,203-206
Any all-cause adverse events. This outcome was reported in eight trials, where it was shown
that the incidence of any adverse events (number of patients with one or more adverse event ), 182­
184,189,191,193,200,203 was higher (either numerically or with statistical significance) in vardenafil
groups (regardless of vardenafil dose or dose regimen) than in placebo groups. The proportions
of patients with one or more adverse event in vardenafil groups across the trials ranged from
about 27 percent (10 mg dose) 182 to 74 percent (20 mg dose). 189 The corresponding proportion
for the placebo groups ranged from about 17 percent 200 to 52 percent. 189
Specific adverse events. In general, vardenafil was described as well tolerated. Most adverse
events were reported as mild or moderate in nature and followed a profile similar to that seen in
other medications of the PDE–5 class (e.g. sildenafil, tadalafil). Most commonly, patients in the
vardenafil arms experienced headache, flushing, rhinitis, and dyspepsia.
Withdrawals due to adverse events. Two 200,206 of the 20 trials 181-184,189,191-201,203-206 did not
report the proportion of withdrawals due to adverse events. Overall, the rate of withdrawals due
to adverse events (i.e., the proportion of patients) in vardenafil and placebo-treated groups of
patients were numerically similar. The withdrawal rate in vardenafil groups across the 18
trials 181-184,189,191-199,201,203-205 ranged from 0 percent 193,195,198 to 5 percent. 192 The corresponding
rate for the placebo-treated patients ranged from 0 percent 193,195,203 to 6 percent. 189 Some of the
reported specific events leading to the withdrawals were myocardial infarction, proctalgia, aortic
bifurcation graft, 212 abnormal liver enzyme levels, 182,192 myalgia, flushing, 181,182 nausea, 192
headache, 181,191,192 kidney calculus, 192 abnormal vision, and rhinitis. 181
Serious adverse events. The absence or occurrence of serious adverse events could not be
ascertained for three trials. 189,199,206 The specific serious adverse events observed across the trials
in patients after random assignment to vardenafil therapy were: skin ulcer, 198 reflux disease, 198
unstable angina, 197 myocardial infarction, 198,201 syncope and encephalitis 198 aortic bifurcation, 201
facial palsy, and appendicitis. 182 Serious adverse events that occurred in 10 trials were not
specified. 181,183,184,191,192,194,196,203-205 In three trials 193,195,200 reportedly no serious adverse events
occurred. In general, judging from the results of these trials, there were no obvious numerical or
statistical differences in the occurrence of serious adverse events between patients randomly
assigned to receive vardenafil and those assigned to placebo.
Vardenafil (fixed dose: 5 mg, 10 mg, 20 mg, 40 mg) versus placebo. In 11 trials vardenafil
was administered at a fixed dose (5 mg, 10 mg, 20 mg, and/or 40 mg). 180-183,189,192-195,198,205
The results of all trials demonstrated statistically significant improvements for patients who
received vardenafil (5 mg, 10 mg or 20 mg) compared with those treated with placebo after 12
weeks of treatment (or longer followup) with respect to the mean IIEF scores for the “EF
domain,” 181-183,189,192,194,198,205 IIEF–Q3/Q4, 189,194 SEP–Q2/Q3, 181,182,192,198,205 GAQ–Q1, 181,182,189,
192,194 and the mean IIEF scores for the domains of “Intercourse Satisfaction,” “Overall
Satisfaction,” “Sexual Desire,” and “Orgasmic Function.” 183,194
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