Results Presented to the American Geriatrics Society Show Improved Scores For
Older Men Similar to Those for Younger Men
WEST HAVEN, Conn., May 9 /PRNewswire/ -- Men over age 65 experienced
improved erections after taking vardenafil, Bayer's investigational treatment
to improve erectile function. The results presented this week at the annual
American Geriatrics Society meeting in Chicago also showed vardenafil was
generally well tolerated.
"Vardenafil enhanced erectile function in older men," said Christopher P.
Steidle, M.D., a clinical associate professor of urology at Indiana University
School of Medicine and co-author of the analysis. "This is an important
finding because men over age 65 are more likely to suffer from impaired
erectile function and also are more difficult to treat."
According to the Massachusetts Males Aging Study, the prevalence of
erectile dysfunction increases dramatically with age. In fact, according to
the study, 57 percent of men in the U.S. ages 60-69 experience some type of
ED(1).
The latest analysis of the large Phase II vardenafil study compared 65
older men (> 65 years) and 134 younger men (18 to 45 years). All had reported
mild to severe impaired erectile function for more than six months. The
patients were randomized into four groups and were given 5 mg, 10 mg, or 20 mg
doses of vardenafil (a phosphodiesterase 5 [PDE-5] inhibitor) or placebo on
demand.
The study participants were evaluated using the erectile function domain,
part of the International Index of Erectile Function (IIEF), a standard sexual
function questionnaire used by urologists. The men answered the questionnaire
after a four-week pre-treatment period and again after 12 weeks of treatment.
Each answer is assigned a points value, with a maximum of 30 points possible.
Anyone scoring between 26 and 30 points is considered to have normal sexual
function.
In this study, the average change in scores for patients taking vardenafil
was similar among the older and younger age groups. The average improvement
for older patients on vardenafil was between 2.5 and 10.3 points, depending on
the dose they were given. The average improvement for younger patients on
vardenafil was between 7.9 and 8.4 points, depending on dose. In contrast,
there was very little improvement in scores for the placebo-treated patients.
The average improvement for older patients on placebo was 0.5 points, the
average improvement for younger patients on placebo was 1.1 points.
The occurrence of adverse events also was similar in older and younger
patients. Those adverse events included headache, nasal congestion, upset
stomach, and flushing.
An earlier, separate pharmacokinetic (PK) study evaluated vardenafil
clearance in the same age groups. A 40 mg dose was given -- higher than that
used in the Phase II trial. Peak levels were reached at a similar time in
both older and younger subjects (mean times of 30 minutes and 36 minutes,
respectively). Vardenafil took slightly longer to clear from the blood in
older men than in younger men. The drug's half-life was six hours for older
men and 4.8 hours for younger men.
"This study suggests that vardenafil is cleared from the body in a similar
timeframe for older and younger men. That is especially important for older
men because you don't want any drug remaining in their bodies longer than
needed," said Dr. Steidle.
Last month at the European Association of Urology meeting in Geneva,
Switzerland, data was presented showing vardenafil improved erectile function
in men regardless of age, cause, or the severity of erectile impairment. In
addition, the study showed vardenafil not only improved erections in up to 80
percent of men, but also increased their ability to complete sexual
intercourse with ejaculation(2).
Vardenafil is an oral treatment currently under investigation to improve
erectile function. Bayer plans to submit a new drug application (NDA) for
this compound to the U.S. Food and Drug Administration later this year.
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. 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 a 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 .
References
(1) Feldman H, Goldstein I, Hatzichristou D, Krane R, and McKinlay J.
Impotence and its medical and psychosocial correlates: Results of the
Massachusetts Male Aging Study. Journal of Urology, 1994: 151:54-61
(2) Porst H, Rosen R, Padma-Nathan H, Goldstein I, Giuliano F, and the
International Vardenafil study group. "Vardenafil, a new highly
selective PDE-5 inhibitor, improves erectile function irrespective of
the baseline severity and etiology of ED or age of patient." (Poster
presented at EAU, 2001.)
SOURCE Bayer Corporation
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Related links:
http://www.viadur.com
CONTACT:
Mary Sawyers of Bayer Corporation,
203-812-3321, or Wendy Blackburn of Fleishman-Hillard for Bayer
Corporation, 816-512-2295
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