Study
shows men with ED favor treatment with Vardenafil
September 20, 2006
Preference trial for ED drugs Sildenafil
vs. Vardenafil attempts unbiased results
Research published in The Journal of Sexual
Medicine and presented at the 12th World Congress
of the International Society for Sexual Medicine
in Cairo, Egypt is unique in that the data is
from a head to head trial of PDE5 inhibitors
used to treat patients with erectile dysfunction
(ED), designed to minimize bias toward either
study drug. The study was a randomized, double-blind,
crossover, head-to-head clinical trial that
compared vardenafil and sildenafil treatment
in men with ED and diabetes, hypertension, and/or
hyperlipidemia. The results demonstrated that
vardenafil achieved nominal statistical superiority
over sildenafil for several frequently used
efficacy measures, and non-inferiority of vardenafil
to sildenafil as measured by various assessments
of patient satisfaction and patient preference.
A total of 1,057 men participated in the study,
which involved treatment using each drug for
four weeks, with a one-week washout period in
between. Patients were asked: "Overall,
which medication do you prefer?" along
with 11 other preference questions relating
to their ED
treatment. Additional efficacy assessments
using established scales were also used in analysis.
Data showed that 38.9% preferred vardenafil
compared to 34.5% sildenafil (26.6% had no preference).
Vardenafil was significantly superior to sildenafil
in terms of erectile function, intercourse satisfaction
and overall satisfaction. There were also a
significant higher percentage of positive responses
for vardenafil with regards to erection hardness
for penetration, maintenance of erection, maintenance
until completion, and erection confidence.
"This study represents an important step
forward in our understanding of the clinical
differences between PDE5 inhibitors, confirming
the efficacy of vardenafil for men with erectile
dysfunction," explains Irwin Goldstein,
study co-author and Editor-in-Chief of The Journal
of Sexual Medicine.
There are currently three PDE5 inhibitors available
to treat ED: sildenafil, tadalafil and vardenafil,
all of which have previously demonstrated efficacy
and tolerability in a range of patient populations,
according to researchers.
Data from head-to-head clinical trials, like
this one, are scarce. However, results from
studies such as this should help clinicians
to differentiate among Sildenafil,
vardenafil, and tadalafil and to select the
most appropriate for individual patients.
Source: http://www.eurekalert.org/pub_releases/2006-09/bpl-ssm092006.php |
