New Study Shows LEVITRA Successfully Treats Erectile Dysfunction (ED) In Men With Dyslipidemia, Including High Cholesterol

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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Oily fish protect Japanese men against clogged arteries

Men’s Health News
If you’re fishing for ways to reduce the risk of heart disease, you might start with the seafood-rich diet typically served up in Japan. According to new research, a lifetime of eating tuna, sardines, salmon and other fish appears to protect Japanese men against clogged arteries, despite other cardiovascular risk factors.
The research, published in the August 5, 2008, issue of Journal of the American College of Cardiology (JACC), suggests that the protection comes from omega-3 fatty acids found in abundance in oily fish. In the first international study of its kind, researchers found that compared to middle-aged white men or Japanese-American men living in the United States, Japanese men living in Japan had twice the blood levels of omega-3 fatty acids-a finding that was independently linked to low levels of atherosclerosis.
"The death rate from coronary heart disease in Japan has always been puzzlingly low," said Akira Sekikawa, M.D., Ph.D, an assistant professor of epidemiology at the University of Pittsburgh, PA, and an adjunct associate professor at Shiga University of Medical Science, Otsu, Japan. "Our study suggests that the very low rates of coronary heart disease among Japanese living in Japan may be due to their lifelong high consumption of fish."
Japanese people eat about 3 ounces of fish daily, on average, while typical Americans eat fish perhaps twice a week. Nutritional studies show that the intake of omega-3 fatty acids from fish averages 1.3 grams per day in Japan, as compared to 0.2 grams per day in the United States.
Earlier studies by Dr. Generique viagra pilules bon marche Sekikawa’s team showed that Japanese men had significantly less cholesterol build-up in their arteries when compared to white men living in the United States-despite similar blood cholesterol and blood pressure readings, similar rates of diabetes and much higher rates of cigarette smoking. It was unclear, however, whether Japanese men were protected by strong genes, a high-fish diet or some other factor.
To answer that question, the ERA JUMP (Electron-Beam Tomography, Risk Factor Assessment Among Japanese and U.S. Men in the Post-World War II Birth Cohort) Study enrolled 868 randomly selected men aged 40 to 49. Of these, 281 were Japanese men from Kusatsu, Shiga, Japan; 306 were white men from Allegheny County, Pennsylvania; and 281 were third- or fourth-generation Japanese-American men from Honolulu, Hawaii.
All study participants had a physical examination, completed a lifestyle questionnaire, and had standard blood tests to evaluate cardiovascular health. Laboratory tests also measured total blood levels of fatty acids and the omega-3 fatty acids that come from fish (specifically, eicosapentaenoic, docosahexaenoic and docosapentaenoic acids).
In addition, researchers used two techniques to measure the level of cholesterol build-up in the arteries. In the first test, ultrasound waves gauged the thickness of the walls of the carotid arteries in the neck, a test known as intimal-medial thickness (IMT). In the second test, an electron-beam CT scanner measured calcium deposits, or "hardened" cholesterol, in the arteries of the heart, a test known as coronary artery calcification (CAC). Both have been shown to identify people at high risk for heart disease.
Dr. Sekikawa and his colleagues found that the total level of fatty acids was similar in the three groups, but the percentage represented by fish-based omega-3 fatty acids was two-fold higher in Japanese men living in Japan (9.2 percent) when compared to white men (3.9 percent) and Japanese-American men (4.8 percent) living in the United States.
The researchers also found that levels of atherosclerosis were similar in Japanese-American and white men, but markedly lower in Japanese men living in Japan. The average IMT was 37 µm less in Japanese than white men after age and cardiovascular risk factors were taken into account, while the average risk-adjusted difference in the proportion of Japanese and white men with positive CAC tests was 11 percent. Both gaps were highly significant, but became statistically insignificant when differences in omega-3 fatty acid levels were taken into account.
In Japanese men living in Japan the investigators also observed that IMT values went down as omega-3 fatty acid levels went up, an inverse relationship that was found to be statistically significant. This relationship between omega-3 fatty acid levels and IMT remained significant even after adjusting for traditional cardiovascular risk factors. (In Japanese men, CAC also went down as omega-3 fatty acid levels went up, but the relationship was not statistically significant.)
No significant inverse association between omega-3 fatty acid levels and atherosclerosis was observed in whites or Japanese-Americans once cardiovascular risk factors were accounted for.
"Our study clearly demonstrated that whites and Japanese-Americans have similar levels of atherosclerosis, which are much higher than in the Japanese in Japan," Dr. Sekikawa said. "This indicates that much lower death rates from coronary heart disease in the Japanese in Japan is very unlikely due to genetic factors."
The importance of the fish-derived omega-3 fatty acids in reducing risk for heart disease is powerfully underscored by this cross-cultural study, said William S. Harris, Ph.D., senior scientist and director of the Metabolism and Nutrition Research Center, Sanford Research/University of South Dakota, Sioux Falls. "Japanese men in Japan have equally bad or worse cardiovascular risk profiles as Americans, but less heart disease? How can this be?" said Dr. Harris, who was not involved in the ERA JUMP study. "What really distinguishes the Japanese men from the Americans is the fact that blood levels of the omega-3 fatty acids are twice as high in Japan as they are in the West.
"The take home message from this important study is this: Traditional risk factors lead to traditional amounts of artery-clogging plaque but only when the background diet, perhaps the lifetime diet, is chronically deficient in omega-3 fatty acids. Increase the omega-3 intake and heart disease rates in the West should begin to move closer to those in Japan. While it may take a high omega-3 diet from birth (as opposed to popping a few fish oil pills) to reach this goal, Dr. Sekikawa and his colleagues tell a compelling story that we would do well to heed."
A follow-up study has recently been funded and will test the association of omega-3 fatty acids with the progression of atherosclerosis in white men, Japanese-American men, and Japanese men living in Japan.

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NexMed Receives FDA Response For Erectile Dysfunction Product

kaufen levitra Ohne Rezept NexMed, Inc. (Nasdaq: NEXM), announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.
Commenting on today’s announcement, Vivian Liu, President and Chief Executive Officer of NexMed said, "The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA’s decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost."
Hem Pandya, Vice President and Chief Operating Officer of NexMed added, "We remain committed to bringing our ED product to market, where there is a real demand from both patients and the urology community at large. As such, we plan to meet with the FDA and come to agreement on the necessary actions required in order to resubmit our NDA and resolve the deficiencies cited." Mr. Pandya further added, "We will also submit to the Agency final reports for two new, two-year carcinogenicity studies in both mice and rats, which were identified in the FDA’s letter as part of the information package needed to resolve the major deficiencies cited."
About NexMed
NexMed, Inc. is leveraging its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. Novartis is completing pivotal Phase 3 trials for NexMed’s NM100060, a novel onychomycosis treatment exclusively licensed to Novartis. In November 2007, the Company signed a U.S. licensing agreement for the ED Product with Warner Chilcott. NexMed’s pipeline also includes a Phase 2 treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information about NexMed, go to
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, obtaining regulatory approval for its products under development, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.
NexMed, Inc.
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New drug for aggressive prostate cancer the best thing in 70 years

Men’s Health News
Scientists say a new drug which treats aggressive prostate cancer is possibly the most significant development in the field for 70 years.
The new drug Abiraterone could they say potentially treat up to 80% of patients with a deadly form of the disease which is resistant to currently available chemotherapy.
Abiraterone works by blocking the hormones which fuel the cancer and is a major step forward in the treatment of end-stage prostate cancer patients.
Prostate cancer is the most common cancer among men and each year, 680,000 men worldwide are diagnosed with the disease and about 220,000 will die from it.
On the assumption that the cancer was driven by sex hormones such as testosterone produced in the testicles, current treatments aim to stop the testicles from producing testosterone.
kaufen levitra Ohne Rezept Now experts have discovered that the cancer can feed on sex hormones from all sources, including supplies of the hormone produced by the tumour itself.
Abiraterone targets an enzyme called CYP17, which plays a key role in this process and works by blocking production of the hormones throughout the body.
An advanced clinical trial involving 1,200 patients around the world is currently under way, with more trials likely later this year.
The latest study is based on just 21 patients with advanced, aggressive prostate cancer who were treated with a ‘once-a-day’ pill.
The study found significant tumour shrinkage, and a drop in tell-tale levels of a key protein produced by the cancer called prostate specific antigen in the majority of patients.
Many of the patients, who have been monitored for up to two-and-a-half years, have reported a significant improvement in the quality of their lives and some were able to stop taking morphine for the relief of pain caused by the spread of the disease to their bones.
Lead researcher Dr. Johann de Bono from the Institute of Cancer Research says while the findings need to be confirmed in larger trials, they believe a major step forward in the treatment of end-stage prostate cancer patients has been made.
Dr. de Bono says men with very aggressive prostate cancer are exceptionally difficult to treat and the disease is almost always fatal.
He hopes that abiraterone will eventually offer them real hope of an effective way of managing their condition and prolonging their lives and that the drug will also help other cancer patients, including those with breast cancer.
Experts say the results are promising but are still at the early stages of clinical development and it will be crucial to carefully examine the balance between its benefits and harms, before reaching a firm conclusion about the new drug.
The researchers say some of the volunteers have been on the drug for as long as two-and-a-half years and were able to control the disease with few side effects.
The drug is now in Phase III trials and Dr. de Bono hopes to have it on the market in 2011.
The research is published in the Journal of Clinical Oncology.
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Men Treated For Prostate Cancer Experience High Levels Of Psychological Distress After Treatment

Generic viagra pills no prescription Men treated for prostate cancer have high levels of psychological distress and many suffer ongoing sexual dysfunction and lower urinary tract symptoms, according to a survey of men in England designed to explore their supportive care needs.
Prostate cancer is the commonest solid cancer in men, accounting for one in every four cancers diagnosed in males in England in 2004. Fortunately, the survival rate for this cancer is improving, reflecting the slow growing nature of the disease and its successful treatment in many men. Nearly three-quarters (71%) of men are still alive five years after being diagnosed with prostate cancer.
A range of treatment options - include surgery, radiotherapy and hormonal treatments - are available for prostate cancer, with the choice being determined by a man’s age, the stage of his cancer and any other conditions that he has. Some of the treatments can have long-term effects on sexual and urological function.
The primary aim of treatment is to optimise cancer control, but some doctors also take into account a man’s urological and sexual function before treatment and the patient’s views on the balance of treatment efficacy against side-effects.
Relatively little is known about the support care needs - the requirements for care arising during illness and treatment to manage symptoms and side-effects - in men treated for prostate cancer. To find out more about how the disease and its treatment affects men, nursing researchers surveyed men with prostate cancer in six areas of England.
The researchers invited 1848 men who had been diagnosed with prostate cancer in the previous three to 24 months, from across six NHS Trusts (geographical regions in the National Health Service) to take part in the research study. Those who replied (820 men) were sent a postal questionnaire asking about their supportive care needs, prostate symptoms, quality of life, their cancer and its treatment; 741 were returned.
Three-quarters of the men taking part in the survey were 65 years old or over, Half (51%) had received hormonal therapy, one-quarter (25%) had radical prostatectomy and 28% had radiotherapy to the prostate. Just under half (46%) of the men said their cancer was in remission.
The survey revealed that the men had significant unmet supportive care needs. The areas of greatest need were related to psychological distress, sexuality-related problems and the management of enduring lowering urinary tract symptoms. The researchers noted: "High levels of psychological distress were reported, and those reporting psychological distress reported greater unmet supportive care needs."
Men who were uncertain of their remission status had higher levels of psychological need, while those not in remission were more likely to have needs for information.
Nearly one-third (30%) of the men taking part in the survey reported moderate or extreme anxiety or depression. A similar number had difficulty with undertaking usual activities. Some or extreme pain was reported by 26% of the men and 22% had problems with mobility.
Virtually all (97%) of the men reported that they had experienced lower urinary tract symptoms, including frequency or needing to urinate during the night, during the month before the survey. Urinary symptoms were affected by treatment, remission status and time since last treatment. They were least severe in men who were in remission, in those who had undergone radical prostatectomy and/or in those who had completed their treatment 19-24 months before the survey.
Unmet needs related to sexuality were more common in younger men and in those who had undergone radical prostatectomy.
The researchers, led by Emma Ream, from the Florence Nightingale School of Nursing and Midwifery, King’s College London, UK, said: "The survey identified high levels of psychological distress within the sample, even though the majority had completed treatment over a year previously." They suggested that need for psychological care was particularly high in men not in remission or whose remission status was uncertain. "The need for systematic assessment and better management of psychological distress in men with prostate cancer was evident in this study," they concluded, adding that sexual dysfunction and lower urinary tract system symptoms also required greater attention by prostate services.
Reference
Supportive care needs of men living with prostate cancer in England: a survey.
Ream E, Quennell A, Fincham L. et al.
British Journal of Cancer advance online publication 2008, 1-7, doi:10.1038/sj.bjc.6604406
Cancer Research Summaries are overviews of important cancer research findings that have been reported in leading cancer publications. The Cancer Research Summaries are provided by the Cancer Media Service (CMS) in collaboration with Nature Clinical Practice Oncology.
"This summary is provided by the European School of Oncology’s Cancer Media Service"
Cancer Media Service
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