February 26, 2002
Patients Reported Vardenafil
Significantly Improved Erectile Function Following Radical Prostatectomy
First Study of its Kind of Treatment to
Improve Erectile Function in Prostatectomy Patients
In the first clinical study of its kind examining the use of drug therapy
to improve erectile function in men who had undergone nerve-sparing radical
prostatectomy (removal of the prostate gland), patients taking vardenafil
reported statistically significant improvement in erectile function. Among
men who had undergone bilateral nerve-sparing surgery, 71 percent of those
taking vardenafil 20 mg experienced improved erections.
Vardenafil is an investigational treatment for erectile dysfunction (ED)
discovered by Bayer AG and will be co-promoted and co-developed with
GlaxoSmithKline plc (GSK). Vardenafil is being evaluated in a broad range of
patient populations, including difficult-to-treat patients.
The new data, presented at the 17th Annual Congress of the European
Association of Urology (EAU), are important because at least one third of
men with prostate cancer who undergo nerve-sparing radical prostatectomy
experience ED. Since 1991, radical prostatectomy has been the most common
treatment for localized and regional cancers.(1) According to the American
Cancer Society, 189,000 new cases of prostate cancer will be diagnosed this
"Men who have had a radical prostatectomy generally experience very severe
ED, as was seen in this study population," said Gerald Brock, MD, Associate
Professor, Department of Surgery, Division of Urology at St. Joseph's Health
Care in London, Ontario, Canada. "The response rates seen in this study are
impressive considering the severe level of ED."
First Study of its Kind Evaluating ED Drug Following Prostatectomy The
multi-center, randomized, double-blind, placebo-controlled, fixed-dose
prospective study was designed to evaluate the effect of vardenafil (a
phosphodiesterase-5 [PDE-5] inhibitor) on erectile function as compared to
placebo in men who had undergone either unilateral or bilateral
nerve-sparing radical retropubic prostatectomy six months to five years
prior to screening. The majority of men (70 percent) enrolled in the study
presented with severe ED.
Following a four-week baseline period, 444 men were randomized to treatment
with vardenafil 10 mg, vardenafil 20 mg or placebo for 12 weeks.
Participants were evaluated using the erectile function (EF) domain of the
International Index of Erectile Function (IIEF), a standard sexual function
questionnaire used by urologists that includes questions about the ability
to achieve and maintain erections to the completion of sexual intercourse.
Participants were also asked to track success in partner penetration and
ability to maintain an erection in a patient diary. In addition, the global
assessment question (GAQ) was used for those men completing the 12-week
study to evaluate if patients experienced improved erections.
Positive Results Seen in Study Population
Patients at all ED severity levels -- mild, moderate, severe -- taking
vardenafil 10 or 20 mg reported statistically significant improvement in
erectile function. Results included:
-- Nearly half of men reported successful penetration compared to
only 22 percent in the placebo group (p<0.0001).
-- An almost four-fold increase in the ability to maintain an erection
was reported compared with the placebo group (p<0.0001).
-- Both doses of vardenafil were significantly superior to placebo
for the EF domain score.
For the 20mg group:
-- 65 percent reported improved erections compared to 13 percent in
the placebo group (p<0.0001).
-- Among the men with severe ED, a seven-fold improvement in
successful intercourse was reported.
The most commonly reported drug related adverse events were headache,
flushing and nasal congestion.
ED and Vardenafil
Erectile dysfunction -- the inability to sustain an erection sufficient for
sexual intercourse -- is a major medical condition among men that is largely
untreated. There are a number of causes for ED, including prostatectomy,
medical conditions, such as diabetes and cardiovascular disease, as well as
psychological factors. Although ED affects an estimated 30 million men in
the United States(2), research shows only 11 percent of men are being
treated for the condition(3), demonstrating the clear need for additional
therapies in this area.
Vardenafil is a PDE-5 inhibitor being researched and developed by Bayer. Its
clinical development program to date has included eight phase III trials
involving approximately 4,000 patients. In a published phase III study in a
broad population, up to 85 percent of patients taking vardenafil reported
statistically significant improvements in erectile function versus
A new drug application for vardenafil was submitted in September 2001 and
accepted for filing by the U. S. Food and Drug Administration (FDA). In
November 2001, Bayer and GSK signed a worldwide co-promotion agreement for
vardenafil. Vardenafil has been submitted for regulatory review for
marketing approval in all major regions worldwide, including the United
States, Europe and Japan.
Bayer Committed to Men's Health
Bayer is committed to improving men's health. Bayer Corporation already has
established itself as a credible force in men's health with Cipro(R)*
(ciprofloxacin HCl) to treat chronic bacterial prostatitis due to E. coli
and P mirabilis. Bayer also is marketing Viadur(TM)**, the first and only,
once- yearly, continuous testosterone suppression therapy to treat symptoms
of advanced prostate cancer. Other men's health products include One-A-Day(R)
Men's High Potency Multivitamin/Multimineral Supplement, One-A-Day(R)
Prostate Health, and Bayer Immuno 1(TM) System Complexed Prostate Specific
Antigen (cPSA) -- an assay used to measure prostate-specific antigen levels
at the time of diagnosis and to monitor them over time.