2001 Annual Fall Meeting, Sexual Medicine Society of North America
WEST HAVEN, Conn., Dec. 8 /PRNewswire/ -- New phase III data for
vardenafil, an investigational phosphodiesterase-5 (PDE-5) inhibitor, reported
statistically significant results in not only achieving improvements in
erectile function for patients with diabetes, but also improved key aspects of
sexual function during the study period. The data were presented today at the
2001 Annual Meeting of the Sexual Medicine Society of North America (SMSNA),
held in Charleston, S.C.
"In the study population, vardenafil patients reported significant
improvement in many aspects of sexual function. Erection quality, frequency
of successful intercourse, as well as significant improvement in intercourse
satisfaction and orgasmic function were reported in many diabetic patients.
Diabetic patients are a characteristically difficult-to-treat population for
erectile dysfunction (ED)," said Irwin Goldstein, M.D., professor of urology
at Boston University School of Medicine, and lead author of the analysis.
"Perhaps the most exciting aspect of our findings is that diabetic patients
who had the most severe ED responded better than those with mild ED. These
results may have significant implications especially in the US, where the
incidence of adult diabetes is at an all-time high."
In this double-blind, placebo-controlled, randomized study of 452 men,
patients taking 20 mg and 10 mg doses of vardenafil reported statistically
significant improvements in erectile function, intercourse satisfaction,
orgasmic function, and overall sexual satisfaction over patients taking
placebo (P<0.0001). In addition, these positive results were noted early and
sustained throughout the 12-week study.
Approximately 7.5 million American males -- more than eight percent of all
men in the United States -- have diabetes. Men with diabetes are three times
more likely to have ED(1) than other men because of complications related to
their condition. Prevalence of ED in men with diabetes over the age of 50 is
reported to be as high as 50 to 60 percent.(2)
Study Design and Findings
The study participants were ages 18 and older with type 1 or type 2
diabetes mellitus and had experienced mild-to-severe ED for six months or
longer. The patients were randomized into three groups and received a 20 mg
or 10 mg oral tablet of vardenafil, or placebo to be taken on demand.
Participants were asked to track their attempts at intercourse in a
patient diary. After a four-week baseline period and again at the end of 12
weeks, the patients were asked if treatment had improved their erections over
the previous four weeks.
In addition to the diary, study participants were evaluated using the
erectile function domain of the International Index of Erectile Function
(IIEF)(3). The IIEF is a 15-question sexual function questionnaire used by
urologists. Questions measure domains of sexual function including erectile
function, intercourse satisfaction, orgasm function, sexual desire, and
overall satisfaction. Scoring is based on a five-point scale, with one being
the most severe. In the erectile function domain, scores 18-25 are classified
as mild ED, 11-17 as moderate ED, and less than 11 are classified as severe
ED.
Positive Results in Improving Erectile Function
Baseline International Index of Erectile Function (IIEF) scores were
similar across all treatment groups and included scores 12.4 for the 20 mg
group, 11.6 for the 10 mg group, and 11.2 for the placebo group, indicating a
study patient population categorized as having moderate to severe ED.
Dr. Goldstein initially presented data which was reported at last summer's
ADA meeting, demonstrating that vardenafil 20 and 10 mg significantly improved
International Index of Erectile Function (IIEF) scores relative to placebo.
Here, Dr. Goldstein showed novel data in which patients were asked to respond
to a diary question relating their ability to achieve successful partner
penetration and completion of intercourse.
In the patient population studied, which exhibited a wide spectrum of
severity of disease, patients having severe ED had a greater improvement in
the percentage of patients achieving successful intercourse (approximately 10-
18 fold) than patients with mild disease (approximately 2-fold).
Positive Result in Improving Intercourse Satisfaction and Orgasmic
Function
Positive findings also were found in other IIEF domains in this study.
Patients in both vardenafil treatment groups reported statistically
significant improvements compared to the placebo group in the intercourse
satisfaction, orgasmic function and overall satisfaction domains.
Side effects associated with this phase III trial were mild to moderate,
transient in nature, and decreased in severity over time. The most common
side effects were headache, upset stomach, vasodilation, and sinusitis.
ED is a largely untreated medical condition
Erectile dysfunction -- the inability to sustain an erection sufficient
for sexual intercourse -- is a major medical condition among men that is
largely untreated. Although ED affects an estimated 30 million men in the
United States(4), research shows only 11 percent of men are being treated for
the condition.(5)
There are a number of causes for ED, including medical conditions, such as
diabetes and cardiovascular disease, as well as psychological factors.
"There is a significant opportunity for additional therapies to treat the
large population of ED patients currently not seeking treatment including many
diabetic men with ED. These findings further demonstrate that vardenafil may
improve key indices of ED in a broad range of ED, regardless of severity,
etiology, and age, even in the most difficult to treat," said Nancy Bryan,
vice president, Marketing in Men's Health, Bayer Corporation.
Committed to vardenafil
A new drug application for vardenafil was submitted and accepted for
filing by the U. S. Food and Drug Administration (FDA). Bayer AG recently
announced a worldwide co-promotion agreement with GlaxoSmithKline plc for
vardenafil, further reinforcing the commitment to bring this treatment to
market successfully.
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.
Best known for its flagship product, Bayer Aspirin, Bayer Corporation
produces a broad range of health care, life sciences, and chemical products
that help diagnose and treat diseases, purify water, preserve local landmarks,
protect crops, advance automobile safety and durability, and improve people's
lives.
Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion
in 2000, and is one of Fortune magazine's Most Admired Companies. The company
employs 23,200 people. It is a member of the worldwide Bayer Group,
a $29 billion international health care and chemicals group based in
Leverkusen, Germany. The Bayer Group (BAYG.DE) stock is a component of the
DAX, and is listed on multiple foreign exchanges.
* View prescribing information for Cipro(R) at ciprousa.com.
** View prescribing information for Viadur(TM) at viadur.com.
This press release contains forward-looking statements, including
statements that include words such as "believe," "anticipate," "expect," or
similar formulations. This forward-looking information contains known and
unknown risks, uncertainties, and other factors that could adversely affect
our businesses or lead the actual results, including the financial situation
and profitability of our company or of the industries in which we compete, to
differ materially from those expressly or implicitly assumed in this forward-
looking information. We assume no liability whatsoever to update this
forward-looking information or to conform such statements to future events or
developments apart from any obligations stipulated by applicable law.
References
(1) Hakim LS, Goldstein I. Chronic complications of diabetes. Endocrinol
Metab Clin1996; 25(2):379-400
(2) American Diabetes Association web site.
(3) Rosen RC, Riley A, Wagner G, Hosterloh I, Kirkpatrick J, Mishra A. The
international index of erectile function (IIEF): a multidimensional
scale for assessment of erectile dysfunction. Urology 1997; 49;
822-30.
(4) Massachusetts Male Aging Study.
(5) Vardenafil market research.
For more information, contact: Ellena Friedman, +1-203-812-2624, cell,
+1-203-464-2758, or Lara Witheril +1-203-812-6558, pager, +1-877-995-2793,
both of Bayer Corporation.
SOURCE Bayer Corporation
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CONTACT:
Ellena Friedman, +1-203-812-2624, cell,
+1-203-464-2758, or Lara Witheril +1-203-812-6558, pager,
+1-877-995-2793, both of Bayer Corporation
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