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Gene Therapy May Treat Erectile Dysfunction

jweiss123 — Sat, 24 May 2008 12:30:46 +0000

TUESDAY, May 20 (HealthDay News) — Gene therapy may be a way to
treat erectile dysfunction in men who do not respond to pills such as
Viagra, researchers report.

Maxi-K gene therapy is a gene transfer that improves erectile
dysfunction. Two studies using the gene were presented Tuesday at the
American Urological 's annual meeting, in Orlando, Fla.

“Gene transfer technology has the potential for long-term improvement
for erectile function,” lead researcher Dr. Arnold Melman, a professor of
medicine at Albert Einstein College of Medicine in New York City, said
during a morning teleconference Tuesday.

“The market for erectile dysfunction is quite large,” Melman said. “And
medications such as Viagra don't work very well in 40 percent of men.”

Melman noted that a recent survey showed that 50 percent of urologists
would consider switching their patients from their current medications to
gene transfer treatment. “So, we think this will be well-accepted by
physicians and patients,” he said.

Results of a phase I trial testing gene transfer in 11 men with
erectile dysfunction who had failed other therapy showed that gene
transfer was safe and also had restorative effects. Four different doses
were tried during the trial. Men receiving the highest dose showed
improvement for up to six months, Melman said.

“These men had normal sexual function for six months and then went back
to the way they were,” Melman said. He added that two doses a year would
be enough for most men to maintain their normal sexual function.

During two years of follow-up, none of the men reported any
abnormalities after the gene transfer. The procedure was safe, and no
adverse effects were seen, Melman said.

Based on these findings, Melman's group is moving on to new trials and
hopes to have a product on the market within two years.

In another trial, four monkeys were fed a high-fat diet, which reduced
their sex drive. After the monkeys received a Maxi-K gene transfer, they
became friskier.

In addition, the number of partial and full erections increased about
fivefold, the researchers found. Also, the frequency of ejaculations
increased among the monkeys that received the gene transfer. Moreover, the
gene transfer affected how the monkeys behaved with female monkeys.

“The most fascinating thing is there was the increased socialization,”
lead researcher George J. Christ, a professor of urology and head of the
Program in Cell Tissue and Organ Physiology at the Wake Forest Institute
for Regenerative Medicine, said during Tuesday's teleconference. “After
receiving a gene transfer and regaining sexual function, they felt better
about themselves.”

More

For more on erectile dysfunction, visit the National Institute of Diabetes and Digestive and Kidney
Diseases.

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Erectile dysfunction predicts heart problems: study

jweiss123 — Fri, 23 May 2008 10:52:49 +0000

NEW YORK (Reuters Health) -
Problems with an
erection may foretell heart trouble ahead for men with type 2
diabetes, two new studies show.

A number of past studies have found a connection between
erectile dysfunction (ED) and heart disease. But the new
findings, published in the Journal of the American College of
Cardiology, confirm that ED often precedes and predicts heart
trouble.

This, say , suggests that men with ED should be
especially vigilant about controlling heart disease risk
factors.

In one study, Italian researchers found that among 291 men
with type 2 diabetes, those who also had ED had twice the risk
of suffering a heart attack, stroke or other cardiovascular
complication over the next four years.

At the start of the study, all of the men had had evidence
of “silent” heart disease — meaning they had plaque buildup in
their arteries on imaging tests, but no heart disease symptoms,
such as chest pain. Having ED seemed to pinpoint those men who
were at particular risk of a complication.

There was some good news as well, however: Taking
-lowering statins appeared to reduce the risks
associated with ED, according to the researchers, led by Dr.
Carmine Gazzaruso of the Clinical Institute “Beato Matteo” in
Vigevano, Italy.

In the second study, Hong Kong researchers found that among
diabetic men with no indications of heart disease at the
outset, those with ED were 58 percent more likely to die of
heart disease, or have a heart attack or other non-fatal
cardiac “event.”

“Erectile dysfunction is an important warning sign of
future adverse heart events or even death,” study chief Dr.
Peter Chun-Yip Tong, of the Chinese University of Hong Kong,
told Reuters Health.

The main reason, he explained, is that ED is an early
manifestation of the blood vessel damage caused by diabetes and
other risk factors for heart disease, such as high blood
pressure.

Tong that all men with diabetes tell their
doctor if they begin to have problems getting or maintaining an
erection. They can then have a comprehensive assessment of
their cardiovascular risk factors — such as measurements of
their blood pressure, cholesterol, waist size and kidney
function — and work on getting those under control.

Indeed, the Italian study suggests that diabetic men with
ED can cut some of their heart risks by using a statin.
Gazzaruso's team found that among patients with ED, those who
were on a statin had a one-third lower chance of suffering a
heart attack or other complication during the study.

There was also evidence that men taking a class of ED drugs
called PDE-5 inhibitors, which includes Viagra, had lower heart
risks. According to the researchers, this may reflect the fact
that the drugs improve the function of the inner lining of
artery walls.

The bottom line, according to Tong, is that men with
diabetes and ED should have all of their modifiable heart risk
factors “identified early and treated aggressively.”

SOURCE: Journal of the American College of Cardiology, May
27, 2008.

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Erectile Dysfunction a Strong Harbinger of Heart Trouble

jweiss123 — Thu, 22 May 2008 01:59:38 +0000

MONDAY, May 19 (HealthDay News) — Findings from two studies of
men with diabetes add to the evidence that erectile dysfunction can be a
powerful early warning sign for serious heart disease.

A Hong Kong study of 2,306 men with diabetes but no signs of heart
disease found that those with erectile dysfunction at the start were 58
percent more likely to have a heart attack or other major cardiac problem
over the next four years than those with adequate sexual function.

And Italian physicians who followed 291 men who had diabetes and early
coronary heart disease for four years reported similar numbers — those
with erectile dysfunction were twice as likely as men without the problem
to have major adverse events, including strokes.

There's a physical connection between male sexual failure and heart
disease, involving the effect of diabetes on the nervous system and the
blood vessels, said Dr. E. Scott Monrad, a professor of clinical medicine
at Albert Einstein College of Medicine in New York City.

“Neuropathy would interfere with the neurogenic responses feeding into
proper erection,” Monrad said. “And of blood flow into the
arteries reduces the pressure needed to achieve erection.”

It has been known that erectile dysfunction shares many risk factors
with coronary heart disease, such as high blood pressure, smoking and
diabetes, according to Dr. Robert A. Kloner, a professor of medicine at
the University of Southern California, who wrote an accompanying editorial
on the reports, which were expected to be published in the May 27 issue of
the Journal of the American College of Cardiology.

“What is new here is that erectile dysfunction remained a significant
risk factor for developing heart disease after for other
cardiovascular risk factors,” Kloner said in a statement.

“These reports add two things to what we already know,” said Dr. R.
Parker Ward, an associate professor of medicine at the University of
Chicago, who led an earlier study linking erectile dysfunction with heart
disease. “One is that they indicate the importance of erectile dysfunction
in diabetic patients in terms of predicting future cardiovascular events.
These studies suggest that the additional presence of erectile dysfunction
places them at incrementally higher risk. Secondly, they show that even
when considered in combination with traditional risk factors, erectile
dysfunction offers incremental information about the risk of future
cardiovascular events.”

Cholesterol-reducing statins lowered the incidence of cardiac events by
a third, the Italian researchers reported, and Viagra and other drugs for
erectile dysfunction also appeared to lower the risk, although the
reduction was not statistically significant, meaning that it could be due
to chance.

“I strongly caution that we do not have enough evidence at this point
that the drugs used for the treatment of erectile dysfunction have any
beneficial effects on the development of heart disease,” Ward said.

Physicians should be more forward in talking about sexual
with men, Monrad said, since “this may prove to be a very sensitive marker
for all the other things we measure for cardiovascular risk, an early and
more sensitive measure if we could get over all our puritanic
inhibitions.”

of erectile dysfunction “should prompt us to be even
more aggressive about lifestyle change, in diet and exercise,” Page said.
“It potentially may suggest more aggressive treatment of risk factors such
as high blood pressure and cholesterol.”

More information

Learn about erectile dysfunction from the National Institute of Diabetes and Digestive and Kidney
Diseases.

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Most Canadian men cut back on fat, but won’t give up meat or try yoga: poll

jweiss123 — Wed, 21 May 2008 00:30:57 +0000

What's this

By The Canadian Press

TORONTO - A new poll suggests the modern Canadian male lifestyle includes cutting back on calories and fat, but very few men are willing to give up their red meat or try yoga.

And it appears more men are worried about their performance in bed instead of the hair from their head.

The Canadian Press Harris-Decima poll asked Canadian men about some of their lifestyle habits and found that a majority were trying to eat healthier.

Seventy-six per cent said they were trying to eat less fat, 63 per cent said they were trying to eat less salt, and 57 per cent were watching their calories.

But only four per cent said they were and only two per cent said they practised yoga.

Only three per cent said they had used a hair-loss medication, while seven per cent of the 1,000 men polled - and 14 per cent of those over 50 - said they had taken medication for erectile dysfunction.

“As Canadian men get older some worry less about hair loss and more about sexual capacity,” said Decima president Bruce Anderson.

“That fully one in seven men over the age of 50 report taking erectile dysfunction medications reveals how large a market has developed for these products in a relatively short period of time.”

The poll was conducted between Feb. 21 and Feb. 24 and is accurate within 3.1 percentage points, 19 times out of 20.

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Canadian men cutting back on fat, but won’t give up meat or try yoga: poll

jweiss123 — Tue, 20 May 2008 00:16:18 +0000

What's this

By Michael Oliveira, The Canadian Press

TORONTO - He’s watching his weight, eating organic and may pop a pill to keep some magic alive in the bedroom, but don’t expect the modern Canadian male to do yoga or give up red meat to stay healthy.

A Canadian Press survey of 1,000 Canadian men suggests there’s a clear trend toward developing better eating habits and a healthier lifestyle.

Seventy-six per cent said they were trying to eat less fat, 67 per cent were eating more fibre, 63 per cent were trying to reduce salt in their diet, and 57 per cent were watching their calorie intake.

But two numbers signal the modern Canadian man will only go so far to attain a better body.

Ninety-six per cent said they eat meat and 98 per cent said no way to yoga.

“We have a very significant number of people who report they’re in pursuit of a healthier food regiment, but what’s interesting is there are far more people who’ll say the approach that they’re taking is looking for more organic foods than (those who) say they’re moving towards vegetarianism,” said Harris-Decima president Bruce Anderson.

“(And while) there are some things that both men and women seem to be pursuing in tandem as part of how they evolve their lifestyles, yoga isn’t one of them.”

The poll results also suggest aging men are more concerned about their in bed rather than going bald.

Only three per cent said they had sought out hair-loss medication, while seven per cent of the 1,000 men polled - and 14 per cent of those over 50 - said they had taken medication for erectile dysfunction.

“As Canadian men get older, some worry less about hair loss and more about sexual capacity,” said Anderson, who thought the numbers were significant erectile dysfunction medications are relatively new to the market.

“That fully one in seven men over the age of 50 report taking erectile dysfunction medications reveals how large a market has developed for these products in a relatively short period of time,” he said. “Obviously these drugs have given lots of people a new lease on at least a part of their life.”

About one in three men - and 53 per cent of men under 25 - also said they wear cologne or after shave on a regular basis.

The poll was conducted between Feb. 21 and Feb. 24 and is considered accurate within 3.1 percentage points, 19 times out of 20.

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Viagra may help heart in muscular dystrophy: study

jweiss123 — Fri, 16 May 2008 03:56:09 +0000

What's this

By Will Dunham

WASHINGTON (Reuters) - A Canadian study involving mice shows that anti-impotence pills might protect the hearts of people with a common form of muscular dystrophy, researchers said on Monday.

Canadian researchers gave sildenafil, the active ingredient in drug maker Pfizer Inc’s Viagra, to mice with an animal version of Duchenne muscular dystrophy, and found that it improved their heart performance.

They said it would be premature to give Viagra to people with the disease, but said the results indicate the drug potentially could be used to prevent or delay heart failure in children with Duchenne muscular dystrophy.

The mice were given doses of the drug comparable to those to treat erectile dysfunction in men. The study, published in the of the National Academy of Sciences, showed that sildenafil cut the levels of damage to contracting heart muscle cells.

“If you don’t give the sildenafil, the heart of these mice doesn’t function as well as normal mice, and they are more susceptible to stress-induced cell death,” said researcher Christine Des Rosiers of the Montreal Heart Institute.

She said in an interview the drug worked to improve heart performance in the mice by preventing the breakdown of a naturally occurring chemical. Called cyclic guanosine monophosphate, or cGMP, it is involved in a number of cellular signaling pathways, the researchers said.

Other impotence drugs also affect the chemical cGMP, including vardenafil, sold by Schering Plough under the brand name Levitra, and tadalafil, sold by Eli Lilly and Co. under the brand name Cialis.

Duchenne muscular dystrophy is an inherited wasting disease characterized by weakness and degeneration of the muscles, including the heart muscle. It begins in the legs and pelvis, and later affects the whole body. Most people with the disease must use a wheelchair by about age 12.

It is caused by a genetic mutation of dystrophin, a protein vital to muscle cells.

Heart problems can appear at around age 10 and they progress quickly, affecting most people with the disease by age 20. These heart problems are an important cause of death among patients with muscular dystrophy.

Sildenafil was developed as a heart drug and is widely prescribed for erectile dysfunction as well as pulmonary . The researchers said discussions are under way about possible future studies using the drug in patients with muscular dystrophy.

“There’s a lot of information on this drug that shows it appears to be relatively safe in adults,” Des Rosiers said, while emphasizing that future human clinical trials are needed before doctors prescribe it for heart trouble in these patients. (Editing by Maggie Fox and Doina Chiacu)

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Health Canada warns against use of product touted to treat erectile dysfunction

jweiss123 — Thu, 15 May 2008 03:11:29 +0000

What's this

By The Canadian Press

OTTAWA - Health Canada is warning consumers not to use an product promoted for the treatment of erectile dysfunction.

In a release issued Friday, officials said the product, Vigoureux, may pose serious health risks, as it was found to contain the prescription drug sildenafil which is not indicated on the product label and should only be used under the supervision of a health-care professional.

Patients with pre-existing medical conditions, including those with heart problems, taking heart medications or at risk for strokes, may be at an increased risk of serious health effects associated with the use of Vigoureux.

Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat.

, the drug may be associated with other side-effects including vision loss, seizure, sudden loss of hearing, dizziness, prolonged erection, headache, flushing, nasal congestion, indigestion and abdominal pain.

Sildenafil should not be used by individuals taking any type of nitrate drug - such as nitroglycerin - due to the risk of developing potentially low blood pressure.

Vigoureux is labelled as being distributed by in Montreal and labelled in French only, but officials said the product may be available at retail outlets across Canada.

Retailers are advised to remove Vigoureux from their shelves, and customers should return the product to the place of purchase. Those who have used it and are concerned for their health should consult with a health-care professional.

Health Canada advises consumers not to use any unauthorized products promoted for the treatment of erectile dysfunction that are advertised as all-natural, as they may contain undeclared pharmaceutical ingredients that may pose serious risks to health.

Consumers requiring more information can contact Health Canada’s public inquiries line at 613-957-2991, or toll-free at 1-866-225-0709.

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Latest product recalls

jweiss123 — Wed, 14 May 2008 00:41:31 +0000

The following recalls have been announced:

_WhiteWave Foods Co. is recalling about 120,000 bottles of Silk Soymilk Chocolate Flavor because they might contain milk protein, which could cause a severe or reaction in people who have milk protein allergies. Four people have had allergic reactions to the product and are now recovering, said spokeswoman Marguerite Copel for the Mount Crawford, Va., company. The recalled 11-ounce single-serve bottles, which were distributed nationwide, have the use-by date of May 7 this year. For more , consumers can call 800-587-2259.

_KG Enterprises LLC is recalling Maxidus supplements, because they may contain active ingredients of FDA-regulated erectile dysfunction drugs that are not declared on the packaging. Samples of the Maxidus supplements contained sildenafil and tadalafil, which could interact with nitrates found in some drugs for diabetes, high blood pressure, high or heart disease. If the active drug ingredients interact with nitrates, it could cause blood pressure to drop to dangerous levels.

The Malasyian-made Maxidus pills were sold online and via mail order until December 2007. They were sold in 10-capsule blister packs inside gold boxes. Details: by phone at 866-373-2488.

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Seller of viagra chocolate faces stiff sentence for mail fraud

jweiss123 — Mon, 12 May 2008 23:53:29 +0000

NEW YORK (AFP) -
A businessman who sold Viagra-laced chocolate as a food called “Boom” was indicted Wednesday for mail fraud by a federal judge, and faces 20 years in jail if found guilty.

Tibor Liska pleaded guilty of selling by mail some 12,000 packets a month of sildenafil — a drug used to treat erectile dysfunction sold under various names, including Viagra — mixed with chocolate and herbs, US Attorney Michael Garcia said.

The “Boom” food supplements were distributed between March 2006 and November 2007 through the Yoi Jin Sei company in the United States, Australia, Colombia, , Russia, Argentina, Japan and Slovakia, Garcia added.

The surrounding the product said it contained food supplements, without that it contained a drug that requires a prescription and could have side effects.

Liska was charged with mail fraud and could be sentenced to a maximum of 20 years behind bars and fined up to 250,000 dollars if found guilty, Garcia said.

He is due for trial on July 25.

Pfizer profit, sales drop after US license losses

jweiss123 — Sun, 11 May 2008 23:03:21 +0000

What's this

NEW YORK (AFP) - Pfizer Inc. said Thursday first-quarter earnings and sales fell due to the expiration of US exclusivity licenses for two key drugs that now face competition from generic versions.

Pfizer reported first-quarter net profit of 2.78 billion dollars, down 18 percent from a year ago, and revenue that fell five percent to 11.85 billion dollars.

The New York City-based drug giant reported adjusted earnings per share (EPS) of 61 cents, falling short of market expectations of 66 cents.

The company forecast for all 2008 adjusted EPS a range of 2.35 to 2.45 dollars, and revenue of 47-49 billion dollars, in line with analysts’ forecasts.

Pfizer attributed the revenue decline to its loss of US exclusivity for anti-hypertension drug Norvasc and antihistamine Zyrtec.

“As we discussed in our fourth-quarter 2007 earnings call and materials, the first-quarter 2008 is not comparable to the year-ago quarter due to the loss of US exclusivity of Norvasc in late March 2007 and Zyrtec in late January 2008,” said Jeff Kindler, the company’s chairman and chief executive.

“These results, however, are in-line with our expectations,” he said in a statement.

In the first three months of the year, sales of Norvasc fell by 556 million dollars from the same period in 2007, and sales of Zyrtec dropped by 344 million dollars.

The lower earnings also were due to an increase of research and development spending linked to the acquisition in 2007 of the laboratories CovX and Coley .

First-quarter revenues were inflated by the declining value of the dollar, which increased sales by approximately 570 million dollars, or five percent.

“Today we are reaffirming our full-year 2008 financial guidance,” Kindler said.

“Many of our new products continued to perform well,” he said, adding that many in-line medicines, such as the erectile dysfunction drug Viagra, showed “steady growth.”

Sales of the anti-cholesterol drug Lipitor fell 18 percent in the US under fierce competition from generics but rose 13 percent in the international markets, the company said.

“We’re continuing to make progress on our cost-reduction initiatives and are well on our way to achieving at least a 1.5 to 2.0 billion dollar reduction in adjusted total costs at the end of 2008 versus 2006, on a constant currency basis,” said Frank D’Amelio, chief financial officer.

“We’re on track to generate 17 to 18 billion dollars in operating cash flow in 2008, and we expect to continue to generate strong operating cash flow beyond 2008.”

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