Aug. 5, 2004 — Erectile dysfunction apparently isn’t just an older man’s problem anymore. Young men, even some who are , are leading the surge in Viagra use.

New research indicates that the use of Viagra skyrocketed 312% among men aged 18-45 between 1998 and 2002. There’s also been a twofold increase — 216% — among men between ages 45 and 55, says Tom Delate, PhD, whose research analyzed data on medical insurance claims by some 5 million patients across the country.

“We tried to see if these patients had an underlying medical condition and we couldn’t identify one in the majority,” says Delate, director of research for Express Scripts, Inc., a St. Louis-based firm that conducts pharmaceutical research for insurers, managed care organizations, and other companies.

“What we found was that problems typically seem to start in a man’s 40s and affected only about 40% of the men in these age groups.”

Enhancer Rather Than Remedy?

Does this suggest a growing trend in using the drug for recreational rather than medical purposes — such as for a sex enhancer?

“That would be my guess,” Delate tells WebMD.

While Delate notes that men older than age 56 continue to fill the lion’s share of prescriptions for Viagra, his study — published in the August issue of the International Journal of Impotence — also shows a 13% increase in Viagra prescriptions for women between ages 18 and 45. While some studies indicate that Viagra can increase sex drive and levels in women, especially before menopause, this is not a finding.

Delate also finds that two in three prescriptions came from primary care physicians, rather than urologists.

“One suggestion about what may be going on: It could be that patients are coming in, asking for the drug, and the prescriber wants to please the patients and meet their expectations,” he tells WebMD. “It could be the primary care physician doesn’t have a lot of time to spend with them, and may not be asking questions.”

July 10, 2000 — In the two years since it rocketed onto the market — and
became, almost overnight, a household word — the impotence drug Viagra has
helped men with erection problems enjoy satisfying sex. The little blue pill
fired the male with the notion of an enduring and youthful virility
that could last into the golden years.

But truth is, Viagra is not the sexual cure-all that many men who have
problems with erectile dysfunction believed it to be. As many as two in five
men who try the drug don’t get the desired results. And at least 39 Viagra
users have died, mostly men who were also taking other drugs, or who had
serious heart disease (see the November-December 1998 issue of Clinical
Therapeutics).

No wonder that early reports of another, perhaps better, drug were so
— both to the media and to men who got no satisfaction from
Viagra. The very name of the new drug — Uprima — conjured up images of
supremacy and conquest.

Then, last week, came the news that threw a splash of cold water on these
oh-so-fond hopes: TAP Pharmaceuticals, the maker of Uprima, unexpectedly –
perhaps temporarily — withdrew its for approval by the Food and
Drug (FDA).

Why did the company pull a product that just weeks ago had been widely
expected to gain FDA approval and give Viagra a run for its money in the
billion-dollar impotence market? Experts speculate that the agency may, in
fact, have been poised to reject the drug’s application or to severely restrict
its recommended use. The reason: serious questions about the drug’s safety at
higher doses and its efficacy at lower ones.

Before submitting its application to the drug agency, TAP Pharmaceuticals
tested Uprima on more than 2,700 men in final clinical trials. The experience
of two of those men, interviewed by WebMD, offers a glimpse at the drug’s
possibilities — and drawbacks.

Aug. 30, 2000 –The popular drug Viagra has improved the lives
of millions, but regular exercise could make it obsolete, according to a report
in the journal Urology.

In the first study of its kind, showed that
physically active men have a lower risk of developing erectile (ED)
than inactive men, even if they don’t begin exercising until midlife. But
surprisingly, the study found that reducing tobacco and alcohol use and losing
weight in midlife didn’t reduce a man’s risk of developing erectile
dysfunction.

“Our study showed that men who burn 200 calories a day,
often by walking briskly for about two miles, can lower their risk of ED
significantly,” says study co-author Irwin Goldstein, MD, a professor of
urology at Boston University School of Medicine. “And men who burn more
than 200 calories a day can lower their risk even more.”

Defined as the inability to have or maintain an erection,
erectile dysfunction affects over half of all men between 40 and 70 years of
age, but isn’t necessarily part of aging.

For their study exploring the effects of lifestyle changes on
ED, Goldstein and colleagues nearly 600 healthy men ranging from
40-70 years of age. After their body mass was calculated, the participants were
polled about their physical activity, smoking habits, alcohol use, and sexual
function. Eight years later, the process was repeated.

Unlike regular exercise, smoking cessation, alcohol reduction,
and weight loss in midlife didn’t reduce the risk of developing erectile
dysfunction, according to the study. “This suggests that midlife changes
are too late to reverse their effects,” Goldstein cautions, “and
highlights the importance of adopting healthy behaviors early in life.”

One of the major causes of erectile dysfunction is hardening of
the arteries, which reduces the amount of blood that can enter and enlarge the
penis. “That’s why we say that good heart health is needed for good
sexual health,” says William Steers, MD, professor and chairman of urology
at University of Virginia in Charlottesville.

“In fact, ED may be an early warning sign of a future heart
attack or stroke,” Steers tells WebMD. “So think about some other ways
to reduce your risk of heart disease and diabetes,” he urges. For example,
men should:

• Stop smoking cigarettes and cigars
• Get their blood pressure under control
• Reduce dietary fat to lower their cholesterol
• Lose excess weight for their height
• Limit alcohol to one or two drinks a day

But even men who get started on a healthy lifestyle early in
life may experience impotence occasionally. “Psychological factors like
depression and anxiety can put the brakes on sexual function, but stress is
probably a bigger issue,” says Drogo Montague, MD, director of the Center
for Sexual Function at Ohio’s Cleveland Clinic and chairman of the American
Urological Association’s ED Guidelines Panel. “It can even lead to
persistent difficulty, so look for ways to relax and clear your mind.”

He also advises that men looking to avoid ED:

• Get adequate sleep to reduce fatigue
• Plan some time together with their partner, away from the kids
• Avoid alcohol before sex

Also, “a common cause of permanent impotence is physical
trauma like spinal cord injuries and pelvic fractures, so remember to wear your
seat belt,” Montague says.

The study was supported by the National Institutes of
Health.

March 24, 2005 — Web sites touting herbal “Viagra” for erectile
dysfunction draw criticism in a new British study.

It’s easy and confidential to find such sites, say the researchers. But
“patients should be cautious as safety and
reliability of this approach is poor,” they write.

They’re particularly concerned that some sites may not provide all the facts
about the products or warn patients to get their heart checked out.

Erectile
dysfunction (ED) may be a sign of heart disease or blood vessel
problems.
These conditions could go undetected and untreated in
patients using herbal treatments, say the researchers. Without knowing the
ingredients or side effects of such treatments, patients could unwittingly put
their health at risk.

ED Affects Millions of Men

Erectile dysfunction (ED) affects nearly 30 million men in the U.S., say the
researchers. ED may stem from physical or psychological issues or a combination
of both factors. It doesn’t mean that men lack desire or sexual interest, and
it’s not a normal, occasional problem. Instead, ED is a man’s consistent
inability to maintain an erection to have sex.

The risk of erectile dysfunction increases with age:

• About 40% of men in their 40s report at least occasional problems getting
  and maintaining erections.
• 52% of men between ages 40 and 70 report erection problems.
• About 70% of men in their 70s report erection problems.

Doctors can prescribe treatments to help, but many men don’t discuss ED with
their doctors. “It is estimated that close to 90% of ED sufferers are still
reluctant to visit their family doctors because of embarrassment,” says the
study.

With Internet access common, some men may go online to look for solutions.
But they may not always get what they bargained for, the study suggests.

Looking at 33 web sites selling herbal substitutes for Viagra, the
researchers spotted red flags including:

• No information from medically trained staff (79% of the sites)
• No statement that the site’s information doesn’t replace medical advice
  (76% of the sites)
• No warning about ED-associated heart disease (None of the sites posted this
  warning.)
• No information about contraindications (64% of the sites)
• No information on side effects (79% of the sites)
• Lack of referenced information (82% of the sites)
• Lack of disclaimers (67% of the sites)
• No information about ingredients (30% of the sites)
• No information on effectiveness of the herbs (18% of the sites)

“All sites fell short of the Health on the Net ,” says
the study.

The Health on the Net (HON) Foundation is a medical and health web site
organization supported by the World Health Organization. HON
provides standards that it recommends health information web sites adhere
to.

What’s in the Bottle?

Herbal treatments aren’t regulated by the government. The most common
ingredients cited in the study were yohimbe,ginseng, and ginkgo
biloba.

Yohimbe can cause headaches, sweating, and high blood pressure, making it
inappropriate for patients with heart and neurological disease, say the
researchers. Reports of diarrhea, vomiting, headaches, and allergic skin
reactions have been linked to gingko biloba, they say.

That’s not to say that those herbs might not have an effect on ED. But the
pros and cons of any treatment — herbal or not — should be made clear, the
study suggests.

Health experts recommend that patients tell their doctors about any
supplements they take (including herbal products and vitamins). That could help
avoid interactions between treatments.

Herbal or Not?

Two years ago, the FDA cracked down on a supposedly all-natural herbal
treatment marketed to men and women to enhance sexual experience. The FDA
learned that the product, called Vinarol,Vinarol, actually contained Viagra’s active
ingredient, says the study.

“It is unknown how many other treatments for ED marketed as
“herbal” supplements actually contain active and potentially dangerous
compounds,” write the researchers, who included Ramesh Thurairaja of the
urology department at England’s Bristol Royal Infirmary.

The study appears in the March/April issue of the International Journal
of Impotence Research.

April 1, 2005 — Fourteen men reportedly have had vision loss while taking the erectile dysfunctionerectile dysfunction drug Viagra, say ophthalmologists at the University of Minnesota.

The men lost only part of their vision. Cases appear to be very rare.

Most of the affected men had other health problems and the structure of their optic nerve (the nerve that handles vision) raised their risk of the condition.

“The number of cases is extremely small,” says Howard Pomeranz, MD, PhD, who details seven of those cases in a new report. The condition is called nonarteritic anterior ischemic optic neuropathy (NAION).

“The likelihood of this happening in an individual is pretty small. It’s a question of weighing the relative risks,” Pomeranz tells WebMD. He suggests that men taking or considering Viagra might want to check with their doctors about any risks.

Pomeranz adds that he’s also heard of three similar cases with another erectile dysfunction drug,erectile dysfunction drug, Cialis. “I don’t know of any with Levitra yet,” he tells WebMD.

The Maker of Viagra Responds

Viagra has been used by 23 million men, says Daniel Watts, a spokesman for Pfizer, which makes Viagra. He says that 103 clinical trials of Viagra have not had any reports of NAION.

“We would say that there does not appear to be sufficient evidence to suggest a single identifying association of these events with Viagra therapy,” says Watts. “We rest with all the data and will continue to monitor the database.”

“I have no reason to doubt their statement,” says Pomeranz. Still, he says that problems not seen in clinical trials later show up after a drug has been widely used for some time.

Pomeranz - in his new report — describes seven new cases since his last report in 2001. He says he’s seen most of the 14 patients himself over the years. The study appears in the Journal of Neuro-Ophthalmology’s March issue.

The seven men experienced partial loss of central and/or peripheral vision, says Pomeranz. The loss wasn’t total, meaning the men didn’t go blind, but it was “permanent in all cases,” says Pomeranz. One man described it as “a shade coming down,” according to the report.

One man had problems in both eyes; in the rest of the men, only one eye was affected, says Pomeranz. The men said the problems started within 24-36 hours of taking Viagra, according to the study.

Risk Factors

The men were all 50-69 years old. Almost all had health problems including high blood pressure, diabetes, high cholesterol, and/or a history of smoking, Pomeranz tells WebMD.

A rare structural problem in the optic nerve was also noted.

“One of the major risk factors identified in this paper was the small cup-to-disk ratio of the optic nerve,” says Pomeranz. “We know that a relatively small percentage of the population as a whole has this small cup-to-disk ratio.” That could raise the risk of NAION. The cup-to-disk ratio is a way doctors measure the small where the optic nerve connects to the retina in the back of the eye. This can be measured during an eye exam.

“One thing people could do is see if they have this risk factor and decide ,” says Pomeranz. He also advises patients to consult a doctor about any eye problems, ” optic nerve problems.”

About 15% of people with NAION in one eye eventually develop it in the other eye, he notes.

March 29, 2004 — Men have high of Viagra, and if the drug fails them the effects can be devastating to their ego, a new study suggests.

found that men are more distressed about erectile dysfunction than previously thought, and the media frenzy surrounding the launch of Viagra has dramatically raised their expectations of treatment.

The study shows that impotence has a considerable impact on men, “with most more deeply shocked than generally realized, their masculinity and self-esteem being particularly affected.”

When treatment with Viagra was successful, men’s self-confidence surged. But if the drug did not work on the first try, the study showed the psychological blow was severe and led to depression in some cases.

Impact of Erectile Dysfunction

Researchers say much attention has been given to the causes of erectile dysfunction, but little is known about the impact of the disorder and its subsequent treatment.

In this study, published in the current issue of the British Medical Journal, researchers interviewed 40 men who attended a men’s health clinic in the U.K. and were prescribed Viagra for erectile dysfunction. The average age of the participants was 52.

The study shows the most common initial reaction to erectile dysfunction was a sense of emasculation.

“For many men, the ability to perform sexually and to satisfy their partner was an important maker of their masculinity,” write researcher John Tomlinson, of the Men’s Health Clinic at Royal Hampshire Country Hospital in Winchester, U.K., and colleagues.

This decline in self-confidence not only affected their sexual relationships, but it also had a negative effect on day-to-day relationships with co-workers and friends. Many men said they felt “old before their time.”

Impact of Treatment With Viagra

Most of the men had first heard about Viagra on television or in newspaper articles and had high expectations of the drug before taking it. Researchers found many men expected to gain an instant erection easily and immediately before sexual intercourse.

Men who were treated with Viagra experienced a boost in self-confidence.

But if the drug failed to work on the first try, the psychological blow was severe. Most tried the drug again, but a second failure just confirmed their negative feelings.

Researchers found all the men who thought the treatment had been unsuccessful expressed a considerable degree of disappointment, and they often attributed it to the media hype that raised their expectations of Viagra.

Many also thought the treatment was unsuccessful because it took the spontaneity out of their sex or because their sex life now depended on medical treatment.

Researchers say the findings suggest that health-care providers need to be sensitive to the effects of erectile dysfunction as well as the impact of its treatment.

“Erectile dysfunction has a major psychosocial impact on men, and health professionals might well also anticipate an impact on personal relationships,” write the researchers. “The media have had a major effect on expectations of the effects of Viagra, and in retrospect, less sensational reporting would have lowered those expectations to the patients’ benefit.”

SOURCES: Tomlinson, J. British Medical Journal, March 29, 2004; vol 328.

Oct. 21, 2003 (Salt Lake City) — With prostate cancer treatment success often comes at a heavy price: erectile . But, a new study shows that Viagra will work in nearly 70% of the men who have erectile dysfunction for years to come.

Michael Zelefsky, MD, of Memorial Sloan-Kettering Cancer Center, N.Y., tells WebMD that the radiation-associated erectile dysfunction usually “begins about six months after they have concluded therapy, but it can occur at any time during or after treatment.” He says that he has already reported that “about 70% of men initially respond to Viagra. However, they didn’t know if the response would be durable.”

In the new study, which was presented at the 45^th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, Zelefsky and his colleagues studied the “durability” of response by following 360 men with radiation-induced erectile dysfunction who initially responded to the drug. He followed the group for an average of nearly four years after their surgery to see if they were still taking Viagra for erectile dysfunction.

The results, he says, were surprising. “I didn’t really expect them to still be taking the drug and I expected that for many men the effect would diminish with time.” But after almost four years, 96% of the men who initially responded to Viagra were still taking the drug and all but six of those men said the drug was still effective.

All of the men in the study had prostate cancer that was confined to the prostate gland. They received radiation therapy by either external beam treatment or by brachytherapy, in which radioactive “seeds” implanted in the prostate deliver radiation directly to the tumor.

The external radiation is done while the patient lies in a special box that allows multiple radiation beams to be directed directly to the prostate gland from all sides, while the rest of the body is protected from the radiation.

Prostate cancer is mainly found in older men. After prostate cancer has been diagnosed, tests are done to determine if it has spread outside the gland. Because there are different available, determining how much the cancer has spread this will help in deciding what treatment is best for the cancer.

Surgery to remove the cancer is one option that is used to treat prostate cancer. Radiation is another therapy used in treating this cancer. Erectile dysfunction can occur in men treated with either one of these treatments.

Zelefsky says the men who reported that Viagra stopped working were those who were treated with extremely high-dose external radiation.

Richard Valicenti, MD, associate professor radiation oncology, at Thomas Jefferson Hospital, in Philadelphia, tells WebMD that the study is “important since it shows that treatment with Viagra can deliver a durable response.” But Valicenti, who wasn’t involved in the study, says that he, too, is a little surprised by the results, because of the fairly large range in the length of treatment and because drug tolerance is common.

“We don’t really know how often they are taking the drug. We know that with repeated use tolerance develops for many drugs and we expect it for this drug as well,” he says.

If tolerance does develop, the new erectile dysfunction drug, Levitra, could be an option says Zelefsky. He says his group is conducting a study with this newly approved drug but notes that it will be sometime before the results are available. Meanwhile, he says that he is trying Levitra in men who don’t initially respond to Viagra.

Jan. 24, 2005 — A drug commonly used to rev up a man’s love life may also eventually be used to help reverse abnormal growth of the heart, according to a new study in mice.

Researchers found Viagra reversed the abnormal growth of heart muscles and restored normal heart function to mice with enlarged hearts.

“A larger-than-normal heart is a serious medical condition, known as hypertrophy, and is a common feature of heart failure that can be fatal,” says researcher David Kass, MD, professor at The Johns Hopkins University School of Medicine and its heart institute, in a news release.

The condition often develops as a result of chronically high blood pressure; this forces the heart to pump harder in order to meet the body’s needs. To adapt to these high forces, the muscles of the heart enlarge.

People with hypertrophy or enlarged hearts have a higher risk of developing heart disease, heart failure, or sudden cardiac death.

Researchers say the findings are the first to show that Viagra may be an effective treatment for a chronic heart condition. The next step will be to conduct a study to see if the drug will have the same beneficial effect in humans that it had in mice.

Viagra May Heal Hearts

In the study, which appears in the Jan. 23 online edition of Nature Medicine, researchers conducted several on mice using Viagra.

In the first experiment, researchers induced the enlarged hearts (hypertrophy) in mice by subjecting their hearts to high blood pressure. But they found mice fed Viagra in their food at a dose similar to those used by humans developed hypertrophy at half the rate as mice that ate regular food.

The mice fed Viagra also showed 67% less scarring of heart muscles, a common seen in enlarged hearts. Researchers say the mice that got Viagra had smaller hearts and better heart function than the untreated mice.

In a second test, researchers used the same dose to examine its effects at reversing pre-existing hypertrophy. The hearts of the mice were exposed to high blood pressure to induce hypertrophy for seven to 10 days, during which they experienced muscle growth and stiffness of nearly 65%.

After two weeks of treatment with Viagra, the muscle stiffness and enlargement almost completely disappeared.

Researchers also found that heart function, which deteriorates with hypertrophy, improved after the muscle growth had been stopped with Viagra treatment.

“This study shows that sildenafil (Viagra) can make hypertrophy go away,” says Kass. “Overall, the results provide a better of the biological pathways involved in hypertrophy and heart dilation, leading contributors to heart failure. They suggest possible therapies in the future, including sildenafil, which has the added benefit of already being studied as safe and effective for another medical condition.”

Kass says “more study is required before we fully understand the benefits of sildenafil on the heart.”