Viagra vs levitra.

May 28, 2002 — Two new contenders have emerged to challenge Viagra, which has dominated the erectile-dysfunction drug market since its in 1998. The new drugs promise to deliver faster erections for a longer time.

Both Cialis and vardenafil are in the last phase of research before FDA approval. Lilly, one of the developers of Cialis, is a WebMD sponsor. Erectile dysfunction specialists presented the most recent findings on these upstart drugs at a recent meeting.

One group reported that men can get an erection up to 36 hours after a single dose of Cialis. In the study, 348 men took either Cialis or a placebo. They were asked to try to have sex 24 hours after taking the pill on two separate occasions, and then try two more times 36 hours after the dose.

Of the men who took Cialis, 57% were able to have sex 24 hours later, and 60% were able to do so 36 hours after taking the drug. In comparison, Viagra’s effect lasts about four hours. Plus, Cialis starts working about 15 minutes after taking it — compared with 30-60 minutes for Viagra.

“Cialis is a very interesting drug,” says Myron Murdock, MD, who is on the medical advisory boards for Cialis and vardenafil. Although these results show that Cialis works for up to 36 hours, “in reality, it’s probably up to 72 hours,” Murdock says. “Somebody who is going to have a significant amount of sexual activity can take two pills a week, and be prepared for the week.”

The drug might not last so long in all men, according to Cialis researcher Hartmut Porst, MD, of Hamburg, Germany. “It depends on individual circumstances,” he says.

Some fears about such a long-lasting drug have been raised, but dismissed. Do men who take it stay erect for days? No, the say. That does not happen, nor do the drug’s potential side effects — headache, backache, facial flushing — last as long as the effect does. “That was surprising to all of us,” Porst says.

The researchers studying vardenafil emphasized a different angle: It works for men with severe erectile dysfunction.

They presented the results of two studies in which more than 1,300 men took vardenafil or a placebo.

percent of the men with severe erectile dysfunction were able to have sex after taking vardenafil. That’s compared with only 2.5% of the men who took the placebo. Vardenafil worked for men with less severe erectile dysfunction, too. More than 70% of those with mild problems and about half of those with moderate problems had normal erections after taking it.

Vardenafil is more like Viagra than Cialis is. “I think the major advantages of vardenafil over Viagra are really not great,” Murdock says. “They both appear to work about the same.”

Of the two new drugs, vardenafil is closer to hitting the market. Murdock says he expects the FDA to approve it in August or September of this year. Cialis is likely to be approved in mid-2003, he says. That’s because the FDA has asked to see more safety data on the drug. “They’re very concerned about abuse of the drug,” he says. “They want to see what would happen if people took this drug excessively for longer periods of time.”

Pfizer, the company that makes Viagra, is playing it cool. Spokesman Geoff Cook says the company does not feel threatened by the competitors. “We actually think that new therapies coming into the marketplace is going to help grow the market,” he says. Most men with erectile dysfunction have not sought treatment. “More products in the marketplace making noise, men to change their behavior and wake up to the condition, is going to drive them into the doctor’s office.”

Other studies to be presented this week hint at future possibilities for treating erectile dysfunction. Gene therapy is one.

Scientists at the Albert Einstein College of Medicine in New York injected rats with a human gene called maxi-K, which seemed to reverse the effects of aging on rats’ penises. The smooth muscle tissue in the penis must relax to allow an erection, but aging decreases its ability to relax. If this gene were to have the same effect on humans it has on rats, it could become a new treatment for age-related erectile dysfunction.

Nov. 6, 2003 - A new type of erectile dysfunction drug that is delivered by nasal spray shows promise in early clinical trials. Instead of directly blood vessels in the penis as the currently available drugs do, the novel treatment targets the brain — specifically, the region of the brain that regulates sexual response.

In a Thursday morning news conference, officials with New Jersey manufacturer Palatin Technologies Inc. said they plan to study the treatment in men who either don’t respond to or cannot take Viagra or similarly acting drugs for erectile dysfunction. They also plan to test it for sexual dysfunction in women and are searching for a corporate partner to help them develop and market the drug, now known as PT-141.

Few Side Effects at Low Doses

More trials of the drug in men with erectile dysfunction are scheduled for completion late in 2006, and the company hopes to win FDA approval within the following year. If that happens, PT-141 could be the first drug approved for erectile dysfunction that acts on the central nervous system.

Another central nervous drug, Uprima, was slated to become the first real to Viagra until its manufacturer withdrew its application for FDA approval in the summer of 2000. According to news accounts, one in 30 men who took the optimal dosage of Uprima fainted or suffered severe low blood pressure as a result.

Urologist and impotence researcher Harin Padma-Nathan, MD, who led trials for both Uprima and PT-141, says low blood pressure was not seen as a side effect in the 271 men taking part in the newly reported PT-141 trial.

“It was very clear that (PT-141) was very different from any other centrally acting agent,” he said Thursday.

He added that side effects with the lowest doses of PT-141 were very similar to what has been seen with Viagra, Levitra, and another drug expected to win approval for the treatment of erectile dysfunction called Cialis. All three drugs work by blood flow to the penis, creating an erection.

PT-141 is in a new class of drugs that works on the part of the brain involved in sexual function.

The chaste older person. The dirty old geezer. The horny old
broad. Stereotypes all.

“The stereotype is grim,” says Walter M. Bortz II, MD,
author of We Love Too Short and Die Too Long. “The reality is that
older people are a lot sexier than younger people think. The common notion is
that when you are old you don’t — and maybe shouldn’t — have sex. Our
studies have shown that older people are sexier in attitude and performance
than they have been credited for.”

And that performance has some documentation.

“You must realize that in the U.S. the biggest use of
is on the day Social Security checks come out,” says John
Morley, MD, director of the division of geriatric medicine at St. Louis
University.

So who’s for the myth that sex becomes unimportant
as one ages?

“People who are older get very little support from the
younger generation about sex,” says Joani Blank, MPH, author of Still
Doing It: Women and Men Over 60 Write About Their Sexuality. “Young
people identify everyone in the next generation with their parents, and of
course they don’t have sex.”

The danger is that people come to accept these stereotypes as
true. They then risk losing one of the most important parts of their lives –
and their health.

“Sex is good for you,” says the 63-year-old Blank, a
sex educator for more than 25 years. “You should continue to have good sex
for the same reason you should continue to get good exercise: It’s taking care
of yourself. Wake up your body again if it has been shut down. Do it whether
you feel like it or not.”

Bortz, a specialist in internal medicine at the Palo Alto
Medical Clinic in California and a clinical associate professor of medicine at
Stanford University School of Medicine, goes even further:

“We should as a moral continue to be
sexually active,” he says. “Is it OK for a 75-year-old widow to say,
‘Sex is not on my agenda any more?’ I would challenge that and say, ‘Maybe you
should make an overt effort to make the rest of your life as full as you can.’
And that includes being daring, flaunting the stereotype.

“Not infrequently an older woman will tell me, ‘I just
don’t give a damn about sex any more,’” Bortz continues. “I say, ‘You
should, because it is important for your life quality.’ She will say,
“Well, is it OK to stop making love if you feel like it?” And I say,
‘No.’ We agree it is not OK not to exercise. If we agree sex is good for you,
you shouldn’t stop — of apathy.”

May 16, 2000 — They used to be advertised on the backs of muscle magazines,
but ever since the huge popularity of Viagra, makers of herbal supplements for
impotence have been touting their products on TV, radio, and the Internet. Some
have even given their products names somewhat reminiscent of Viagra, like
BioVgA.

Few of these herbal products have been through the rigorous testing required
of FDA-approved drugs. What’s more, no federal agency enforces quality control
over their ingredients. So consumers may not know exactly what they’re buying
– whether a jar labeled “ginseng,” for example, really has ginseng in
it, or even whether ginseng is safe and effective.

Yet, across the herbal supplement industry, change is afoot. “In the
past few years, this industry has been in a fishbowl,” Mark Blumenthal,
founder and executive director of the nonprofit American Botanical Council,
tells WebMD. “We’re not waiting for the FDA to regulate us. We’re doing it
ourselves.”

A case in point: ArginMax, an herbal mix touted to improve sexual function
in men, manufactured by The Daily Wellness Co. of Mountain View, Calif. It’s
one of a growing number of herbal products being tested in controlled
scientific studies.

In Hawaii, Thomas Ito, MD, has conducted preliminary trials of ArginMax,
which contains L-arginine, an ingredient that has been shown to trigger a
buildup of nitric oxide in the bloodstream and thus expand blood vessels.
Ginseng and ginkgo biloba also are in the mix.

“We feel these are critical ingredients … chosen based on extensive
research,” Ito tells WebMD. “About 35 papers back up the
ingredients.” Ito has presented results of his research at regional
meetings of the American Urological Association, and has submitted a paper for
publication in the well-regarded professional journal Urology. Ito, a
former assistant clinical professor of urology at the University of Hawaii
School of Medicine, is now an industry consultant.

One of Ito’s studies involved 48 men, each of whom received a capsule at his
urology clinic daily for four weeks. Half received the herbal formulation; half
received a sugar pill. No one, including Ito, knew who was getting the real
thing, Ito says. “We chose capsules, so no one could smell or taste the
differences,” Ito tells WebMD.

Nearly 88% of the participants who got ArginMax reported achieving better
erections, and 75% said they had an improved sex life overall. Even the placebo
group said they had better sex: 18.75% reported improved erections, and 18%
reported an overall better sex life during the study. All the patients were
checked for blood pressure and appetite changes, but no side effects were
detected, says Ito, who is conducting additional studies at a Veterans’
Hospital in northern California.

For women having sexual problems, a similar ArginMax formulation is being
tested, Mary Polan, MD, PhD, chairman of obstetrics and gynecology at Stanford
University School of Medicine, tells WebMD. She presented results of her
preliminary study of the product at an international meeting on female sexual
dysfunction in Boston last fall.

Her trial involved 49 women either nearing or at menopause, all reporting
sexual dysfunction. “Across the board, there was a significant increase in
sexual in the women on the drug compared to the control
women,” Polan says. Some 76% of the group on the ArginMax formulation
reported improved sexual desire, while 72% had greater satisfaction in their
sex lives, 64% had an improved sexual relationship with their partners, 60% had
better clitoral sensation, and 52% had more frequent orgasms.

The placebo effect definitely came into play, as in the men’s study, Polan
tells WebMD. In one category, for example, “Thirty percent of women got
better on the placebo. But 60% of women get better on the drug. So there’s a
significant difference.”

Polan says she was encouraged by the results. “I take care of a lot of
peri- and women, and probably the second biggest complaint is
decreased or ineffective sexual functioning.” Currently, there is no
similar drug for women nearing menopause, although therapy
is reported to improve sexual functioning in menopausal women. There have been
no large-scale trials of Viagra involving women, Polan tells WebMD.

The women’s compound contains L-arginine, ginseng, ginkgo biloba, and the
herb damiana, which is supposed to promote the relaxed state of mind that is
important for sexuality in women, Polan says. Vitamins and minerals also were
added.

She intends to follow the women in her study to determine the compound’s
long-term effects, and hopes to launch a larger trial. But how does a Stanford
professor become involved in testing an herbal supplement in the first
place?

The theory behind the product made sense to her, she says. “I felt it
was a group of people who understood you need to develop some data. It’s a
small start-up company, so we’re not talking about mega trials, but there
should be some critically evaluated information. … And I think we’ve shown
that.”

As for supplements in general, “who knows what all this stuff out there
does for people?” Polan says. “Of course, if you live in California,
many people use nutritional supplements as their sole source of medication. …
I never know what to tell patients, so when I see medications that at least
have data behind them, I feel more comfortable.”

Buyer beware, says one of the country’s top prostate cancer surgeons,
William Catalona, MD, a urologist with Washington University School of Medicine
in St. Louis. He has seen thousands of men facing sexual dysfunction.

And he’s heard bad reviews of the herbals: “A lot of patients try
these medications. And some feel they help a little bit, but most of the word I
get would not suggest that they are effective. … Patients ask, but I usually
don’t recommend them because they haven’t been tested and approved by the FDA
to show they are safe and effective.”

While the theory about L-arginine “could conceivably work,” says
Catalona, “I’m not sure there’s any practical evidence to show it really
does this. … Even though Ito’s studies look positive, there’s not absolute
proof at this point. With Viagra, it’s been through the FDA, so we know it’s
definitely effective. As for its safety, the safety guidelines are pretty
good.

“What you see in some advertising for herbals is they jump all over
the fact that Viagra is said to cause deaths,” he adds. “So I have a
lot of patients who don’t have heart disease or anything else that would make
Viagra dangerous to them, but their wives won’t let them take it. … So some
people who are afraid of Viagra take these things.”

Those who want to go the natural route sometimes turn to naturopathic
physicians like Don Brown, ND, who tells WebMD, “L-arginine
is pretty safe; there aren’t a lot of concerns. Nitric oxide has a mild blood
vessel expanding effect. We know it does that.” Still, he says, “I
would consider the research on L-arginine at this point to be very, very
preliminary with regard to its effect on erectile dysfunction.”

The problem is that dietary supplements are unregulated, Brown tells WebMD.
“Mechanism of action becomes the way that it’s promoted to the public, and
yet there aren’t any good clinical trials to back up their claims.”

From the offices of the American Botanical Council, Blumenthal takes issue
with that. “One of the biggest myths about the entire botanical/herbal
medicine industry is that it is unregulated.” Although these supplements
are not regulated as drugs, he says, “any claims must be truthful and not
misleading. They have to be backed by scientific evidence.” The Federal
Trade Commission recently obtained large financial settlements from two
supplement companies whose advertising made unsubstantiated claims.

The FDA is expected to issue some new, more stringent regulations for the
manufacturing of herbal supplements later this year. The quality control of
supplement manufacturing will then be required to meet the same standards as
that for foods — “somebody that makes tomato paste or tomato sauce or
apple juice,” Blumenthal says.

His has been trying for seven years to push the supplement
industry toward higher standards, by testing 500 commercial ginseng products.
“We have done it by the book and done it very fair, tested everything twice
to make sure everything is accurate, contacted the manufacturer once we found a
negative finding, and gave the opportunity to rebut our claim or explain the
situation,” Blumenthal says.

“Many manufacturers have told us that either … because they knew we
were testing ginseng or because they got an adverse finding from us, that they
totally overhauled their operation. Now, not only is their ginseng better, but
everything else they produce has a higher degree of reliability of the quality
because they learned a lesson from us on the ginseng.

“And we haven’t even published anything yet. They saw it was inevitable.
The handwriting was on the wall.”

For more information on evaluating herbal supplements, visit www.consumerlab.com or www.healthnotes.com.

Erectile dysfunction (ED), commonly known as impotence, can be
troubling, even devastating, to a man. But it can be equally so for his partner
as well, as Beth (who asked that her real name not be used) found out.

“It really a relationship,” says Beth, who
recently broke off an engagement with a man who suffers from ED. It’s
especially difficult, she adds, if the man blames his partner, as her fianc
did.

“Even though my fianc admitted that he had always had
difficulties with his erections,” says Beth, “he tried to tell me that
it was my fault. After you hear that enough, you start to believe it, and it
can really affect your .”

That’s not unusual, says Karen Donahey, PhD, director of the
Sex and Marital Therapy Program at Northwestern University Medical Center in
Chicago. “A woman may struggle with the notion that she’s no longer
attractive to her man,” says Donahey. “Even if the man assures her it’s
not true, there’s still a worry there.”

The stronger a woman’s self-esteem is, says Donahey, the less
threatened she’ll feel by her partner’s erectile dysfunction and the more
supportive she’ll be able to be.

ED Is Not Uncommon

“It’s important for both men and women to realize that ED
is not at all uncommon,” says Donahey. Indeed, most estimates suggest that
at least 50% of men in the U.S. experience some form of sexual dysfunction at
some point in their lives. ED is one of the most common male sexual problems,
affecting an estimated 30 million men in the U.S. and approximately 140 million
men worldwide.

Though ED may indeed be common, it’s still stressful, and in a
study conducted by Pfizer (which makes the impotence drug Viagra), research
showed that most women, where their quality of life is concerned, rank ED
higher in importance than menopausal symptoms, infertility, allergies, obesity,
and insomnia.

In a series of focus groups, Pfizer researchers found that when
faced with ED, women — and their partners — either acknowledged that they had
a problem or denied the existence of a problem. “While this may be
intuitive, our research showed that there are in how women
acknowledge the problem and how they deny the problem,” says Janice Lipsky,
PhD, senior marketing manager for the sexual health team at Pfizer.