Results of the first
prospective trial specifically designed to evaluate erectile function in
erectile dysfunction (ED) patients with dyslipidemia show that LEVITRA(R)
(vardenafil HCl), used in treating ED, significantly improves the ability
of men with ED and dyslipidemia to achieve and maintain an erection for
successful sexual intercourse. These data were presented at the Sexual
Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to
measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who
all had ED and dyslipidemia. Results from the study of 395 men show that
LEVITRA significantly increased rates of penetration (as measured by SEP2
scores) and the ability to maintain an erection (as measured by SEP3
scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not
treating ED, a life-changing condition," said Dr. Martin Miner, Clinical
Associate Professor of Family Medicine at Brown University’s Warren Alpert
School of Medicine. "This study provides further support that LEVITRA can
successfully treat ED, even in men with a serious common condition like
high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States
who have ED also have other common conditions such as dyslipidemia
(including high cholesterol), hypertension, or diabetes, which may lead to
erectile dysfunction. Previous studies have demonstrated the efficacy and
safety of LEVITRA in men with ED who also have high blood pressure or
diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64
that had ED and dyslipidemia were randomized to treatment with LEVITRA or
placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically
relevant improvements in SEP2 scores (a rating system that measures
penetration) and SEP3 scores (a rating system that measures maintenance of
erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs.
51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index
of Erectile Function) scores also were significantly higher for the LEVITRA
group compared to the placebo group. These scores are evaluated based on a
patient questionnaire and their daily diary response to specific questions
about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects
(occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for
placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for
placebo).
Background: Erectile dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a
man to attain and/or maintain a penile erection sufficient for sexual
performance. ED can be a total inability to achieve an erection, an
inconsistent ability to do so, or a tendency to sustain only brief
erections. It is estimated that some degree of ED affects up to 30 million
men in the United States.
Some of the most common treatments for ED include adjustments to
lifestyle and better control of concomitant medical conditions as well as
the use of oral medications or other forms of therapy. Treating related
health conditions or reducing stress may help maintain erectile function.
About LEVITRA
LEVITRA (vardenafil HCl) is a prescription medicine that is indicated
to treat erectile dysfunction (ED). Consistent with the effects of PDE5
inhibition, administration of LEVITRA with nitrates and nitric oxide donors
is contraindicated.
Caution is advised when PDE5 inhibitors, including LEVITRA, are used
concomitantly with stable alpha-blocker therapy, because of the potential
for lowering blood pressure.
LEVITRA is not recommended for patients with uncontrolled hypertension
(>170/110 mmHg).
In men for whom sexual activity is not recommended because of their
underlying cardiovascular status, any treatment for erectile dysfunction,
including LEVITRA, generally should not be used.
In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir,
saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and
clarithromycin), lower doses of LEVITRA are recommended, and time between
doses of LEVITRA may need to be extended. See prescribing information for
LEVITRA for dosing guidance.
In clinical trials, the most commonly reported adverse events with
LEVITRA were headache, flushing, and rhinitis. Adverse events were
generally transient.
Nonarteritic anterior ischemic optic neuropathy (NAION) has been
reported rarely postmarketing in temporal relationship with the use of PDE5
inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with
tinnitus and dizziness, also has been reported rarely in temporal
association with the use of PDE5 inhibitors, including LEVITRA. It is not
possible to determine if these events are related to PDE5 inhibitors or to
other factors. Physicians should advise patients to stop use of PDE5
inhibitors, including LEVITRA, and seek prompt medical attention in the
event of sudden loss of vision or hearing.
The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg
or down to 5 mg based on efficacy and side effects.
The maximum recommended dosing frequency is once daily.
LEVITRA is available in 2.5-mg, 5-mg, 10-mg and 20-mg tablets.
For Prescribing Information please visit
About GlaxoSmithKline
GlaxoSmithKline - one of the world’s leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline at
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough’s vision is to "To Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
approximately 50,000 people around the world. The company is based in
Buy cipro without prescription Kenilworth, N.J., and its Web site is
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release contains certain "forward-looking" statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
related to the potential market for LEVITRA. Forward-looking statements
relate to expectations or forecasts of future events. Schering-Plough does
not assume the obligation to update any forward-looking statement. Many
factors could cause actual results to differ materially from
Schering-Plough’s forward- looking statements, including market forces,
economic factors, product availability, patent and other intellectual
property protection, current and future branded, generic or
over-the-counter competition, the regulatory process, and any developments
following regulatory approval, among other uncertainties. For further
details about these and other factors that may impact the forward-looking
statements, see Schering-Plough’s Securities and Exchange Commission
filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough’s
third quarter 2007 10-Q.
Schering-Plough
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