Beste apotheek van Nederland

Results obtained from two trials 193,195 showed a statistically significant increase in the mean
duration (in minutes) of penile tip/base rigidity (>60 percent) in patients randomly assigned to
receive vardenafil at a dose of 10 mg, 195 20 mg, 193,195 or 40 mg, 193 as compared with those
randomly assigned to receive placebo.
In one trial, 180 patients treated with vardenafil (20 mg), in comparison with those treated with
placebo, experienced a statistically significant improvement in endothelial function measured by
the degree of brachial artery flow-mediated dilation (13.0 percent versus 10.7 percent).
The beneficial effects of vardenafil use relative to that of placebo observed in trials of
homogeneous clinical groups such as diabetes, 181,205 nerve-sparing retropubic prostatectomy, 183
and no previous ED treatment 180 were consistent with those of other trials conducted in
participants with ED and a wide spectrum of diseases. 182,189,192-195,198
Treatment efficacy subgroup analyses (i.e., stratified efficacy results) were reported for five
trials with respect to the origin of ED, 180,194 baseline severity of ED, 182,192,194 age groups, 194 and
previous sildenafil use. 194,198 The results of these analyses indicated numerically greater
improvements associated with milder forms of ED, 192,194 no previous use of sildenafil (i.e.,
sildenafil-naïve patients), 198 and arteriogenic ED (versus organic nonarterial or psychogenic
ED). 180 In one of these trials, 194 the degree of improvement in IIEF “EF” domain scores was not
modified by age, previous sildenafil use or the origin of ED (organic, mixed, or psychogenic).
Vardenafil (flexible dose: 5 mg- 10 mg- 20 mg) versus placebo. Ten trials administered
vardenafil with a flexible daily dose (5 mg, 10 mg, 20 mg). 184,191,196,197,199-201,203,204,206 The results
of all trials demonstrated statistically significant improvements for patients receiving a flexible
dose of vardenafil compared with those treated with placebo after 12 weeks of treatment (or
184,191,197,199-201,203, 204, 206
longer followup) with respect to the mean IIEF scores for “EF domain,”
IIEF–Q3/Q4, 200,206 SEP–Q2/Q3, 184,191,196,197,199-201,203,204 and GAQ–Q1. 184,191,196,199-201,203
Statistically significant improvements in vardenafil-treated patients, relative to those on placebo,
were also observed with respect to mean scores for the following IIEF domains: “Intercourse
Satisfaction,” “Overall Satisfaction,” “Orgasmic Function” 199,200 and/or “Sexual Desire.” 199,204
In four trials, 184,201,203,204 at followup after 12 weeks of treatment, a statistically significant
greater proportion of patients with an IIEF “EF” domain score ≥26 was found in groups treated
with vardenafil compared with those who received placebo.
The relative beneficial effects of vardenafil use with respect to the above-mentioned
outcomes observed in trials of homogeneous clinical groups, such as patients with diabetes, 204
renal transplant, 206 untreated mild major depressive disorder, 199 or arterial hypertension, 196 as
well as sildenafil nonresponders 184 and sildenafil- naïve patients 201,204 were consistent with those
of other trials conducted in participants with ED and a wide spectrum of diseases. 191,197,200,203
Treatment efficacy subgroup analysis (i.e., stratified efficacy results) was reported for only
one trial 191 with respect to dose-sequence, in which patients who received a stable dose of 10 mg
vardenafil over 12 weeks experienced greater improvements on the mean scores for IIEF “EF
domain,” SEP–Q2/Q3, and the proportion for GAQ–Q1 compared with those who gradually
increased their vardenafil dose to 20 mg over the followup of 8 weeks.
Vardenafil dose 1 versus vardenafil dose 2. There were 10 trials with two or more dosespecific
arms of vardenafil. 181,183,189,190,192-195,198,205 None of the trials were designed to compare
flexible and fixed dosage regimens of vardenafil.
Harms. Any all-cause adverse events.
In seven 183,189,190,192,193,195,205 of the 10 dose-response studies, 181,183,189,190,192-195,198,205 the
incidence of any adverse events was shown to be numerically dose-dependent, increasing with a
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