April 1, 2001 — Move over, Viagra: A team of researchers has found that an experimental form of gene therapy can restore over-the-hill male rats to the sexual potency — as measured by their ability to have erections — of studly young rats just a third their age. The therapy was described at the annual Biology meeting in Orlando, Fla.

Although the therapy is far from being ready for prime time in humans, it has potential as a long-acting treatment that could help to restore youthful vigor to men with erectile dysfunction, report Trinity Bivalacqua and colleagues from Tulane University in New Orleans and Johns Hopkins University in Baltimore.

In their study, the researchers injected into the penises of aged rats a cold virus modified to carry a gene that helps blood vessels in the penis to expand and fill with blood, one of the key steps necessary to creating and sustaining an erection.

“We looked at the physiology, asking is this going to help these animals get better erections, which it did,” Bivalacqua, a medical student at Tulane University, tells WebMD.

Erections are controlled by a complex series of events involving nerves and the signals they carry, as well as hormones and other substances that control the expansion of blood vessels, so it’s not surprising that any one of several defects or disruptions of one of the mechanisms involved in sexual performance in men can result in erectile dysfunction.

One method for treating erectile dysfunction has been through direct injection into the penis of substances that stimulate the release of chemicals within the penis that control the relaxation of smooth muscle. When smooth muscles surrounding the blood vessels in the penis relax, they allow more blood to enter, thereby causing an erection. Drugs like Viagra work by interfering with an enzyme that would otherwise prevent relaxation of smooth muscle.

, penile injections and Viagra are one-shot deals and need to be repeated every time a man with erectile dysfunction wishes to have sexual intercourse.

To see whether they could create a treatment for erectile dysfunction, Bivalacqua and colleagues injected into the penises of aged male rats a harmless cold virus, called an adenovirus, that had been modified to carry a gene for an important neurotransmitter, or chemical messenger, involved in erections.

Five days after the injections, the rats underwent nerve stimulation to simulate a normal erection, and their responses were compared with those of other rats one-third their age. The researchers found that older animals that received the adenovirus had erectile responses comparable to those of young rats. In contrast, older rats injected with a different gene not associated with erectile function had no significant in function.

The researchers also found evidence that the virus continued to be present in penile tissue for up to 30 days, suggesting that the therapy, if found to be safe and effective in humans, could be delivered once a month rather than before every episode of sexual intercourse — no doubt a welcome prospect to men who are squeamish about the idea of penile injections.

But a urologist who studies gene therapy for erectile dysfunction tells WebMD that there are several drawbacks to using adenoviruses as carriers for genes.

“As a strategy in humans, I think adenovirus has some drawbacks in that it’s inflammatory, and usually repeated doses will cause an immune system reaction. I think we need to keep trying different genes, and we also need to start looking at long-term strategies for gene expression, because these are temporary and won’t be permanently incorporated into the penis,” says Hunter Wessells, MD, associate professor of urology at the University of Washington School of Medicine in Seattle.

Craig F. Donatucci, MD, a urologist who specializes in research and treatment of erectile dysfunction at Duke University Medical Center in Chapel Hill, N.C., tells WebMD that ” it makes sense, because you fix the problem, but then you have the issue about the dangers of adenoviruses.”

Donatucci points to the 1999 death of a patient at the University of Pennsylvania who was undergoing experimental gene therapy with an adenovirus for correcting a lifelong metabolic disorder. “If you’re talking just about erectile failure, what’s your safety level? Where do you set that?” he asks. “From a general philosophical viewpoint, it’s very attractive to think of gene therapy in the future, putting in some form of gene therapy, but realistically, it’s a long way from happening.”

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Sept. 23, 2002 — The long-awaited competitor to Viagra — christened Levitra today — inches its way to final FDA approval. Two early studies suggest it’s longer lasting, has fewer side effects, and is safe for virtually everyone, including those with heart problems. Similar drugs approved in this class of medication carry warnings for men with heart disease.

However, one urologist advises men not to get their hopes up. “That’s not to say new drugs won’t be exciting and wonderfully worthwhile,” Larry Lipshultz, MD, professor of urology at Baylor College of Medicine in Houston. “The data is interesting. Let’s see if the drug holds up to the claims.”

Levitra was developed by Bayer and GlaxoSmithKline and is scheduled for U.S. launch in 2003.

Viagra, produced by Pfizer Inc., revolutionized the treatment of male sexual dysfunction, allowing men for the first time to pop a pill to get an erection — rather than trying various devices, having a drug injected into the penis, or having a pellet inserted into it.

By some estimates, some degree of ED affects more than 50% of men over the age of 40. In the U.S., alone 30 million men are affected.

However, statistics show that only about 10% of men seek help. So 90% of men out there still aren’t getting treated for impotence, says Irwin Goldstein, MD, director of the Institute for Sexual Medicine at the Boston University Medical Center and a leader of the Male Aging Study.

“In the early days of Viagra, many men got turned off — largely because reports of heart attacks that were shown later not to be related to the drug,” Goldstein tells WebMD. Today, Viagra carries only an advisory for people with high blood pressure who are taking particular types of blood pressure-lowering medication, and patients with angina or heart disease who take nitrates.

The preliminary data on Levitra:

A phase III clinical trial enrolled 440 men with erectile dysfunction between 44 and 77 years old, most of whom had undergone nerve sparing six or more months before entering the study. (About a third of men who have had a prostatectomy — removal of the prostate gland — develop ED.) After 12 weeks of Levitra, 71% of the men had improved erections. And a subset of men depression related to their impotence reported fewer symptoms of depression after taking Levitra.

In a 26-week phase III trial of 805 men, about 74%-77% of men taking 10-20 mg of Levitra reported successful penetration on their first attempt, compared with 46% of men taking placebo. Also, the men who were successful the first time reported successful penetration in about 85%-91% of subsequent attempts, compared with 77% of those taking placebo. Side effects were mild to moderate headache, flushing, and nasal congestion — “mild stuff,” says Goldstein.

Both Viagra and Levitra work by inhibiting the PDE5 enzyme. “That means that if you take a pill, then have sexual stimulation, the drug can magnify the natural erectile response. It allows the reaction to be more like sex should be.”

The biochemical between the two drugs mark the difference, he says. “Levitra contains a more efficient enzyme inhibitor, so only a very small amount of the drug is necessary,” Goldstein tells WebMD. “That’s the thing that’s cool about Levitra — it’s biochemical potency is distinctly different from Viagra and Cialis another impotence treatment drug being developed by Lilly.”

All three drugs — plus several more still in development — have their place in a physician’s armamentarium, says Goldstein. “Several other companies are also working on drugs with PDE5 inhibitors.”

When it starts to work and how long it lasts are big issues in impotence medicine: Viagra takes effect in about 30 minutes and the effects last about 4 hours. Cialis reaches maximum concentration in 24 hours, and the effects last for about 3 days, says Goldstein. Levitra is faster-acting, reaching maximum concentration in 30 to 40 minutes, with the effects lasting about 16 hours.

Also, Levitra doesn’t carry one disconcerting visual problem that many men report with Viagra: “If you take Viagra, you get a weird blue vision,” he says.

Just don’t expect miracles with Levitra, says Lipshultz.

“The strength of the drugs will probably be comparable — they’re all supposed to inhibit the enzyme PDE5,” Lipshultz tells WebMD. “Whatever dose you take inhibits it completely. So I don’t think we’re going to be seeing a whole lot of advertising based on ‘take this drug because it’s stronger.’”

Also, if you didn’t have success with Viagra, it’s doubtful that Levitra will work any better, says Lipshultz. “I don’t think we’re going to see people who fail one drug do a whole lot better on another drug. I think where the difference will be — if any — is onset of action, duration of action, and side effects.”

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May 19, 2004 (New Orleans) — New medicines — ranging from a
relative of Viagra to an arthritis drug — target the haywire immune responses
that underlie inflammatory bowel disease (IBD).

bowel disease is the umbrella term for a number of
conditions that cause inflammation of the bowel. The two most common ones are
ulcerative colitis and Crohn’s disease. Both of these conditions occur when the
immune system goes awry and attacks the lining of the colon. The disorders take
a toll on their victims - affecting more than 1 million in the U.S. alone –
causing belly aches, diarrhea, and other symptoms that are often severe enough
to interfere with daily activities, says James B. Lewis, MD, associate director
of the inflammatory disease program at the University of Pennsylvania in
Philadelphia.

“We’re seeing many different approaches to treat this
inflammation,” says Stephen B. Hanauer, MD, professor of medicine and
clinical pharmacology at the University of Chicago Pritzker School of Medicine.
“For example, already used to treat IBD, are effective
agents but they affect all tissues, causing many side
effects.”

Many of the new drugs, on the other hand, selectively target
the defects associated with IBD — an approach that promises better results
with fewer side effects, he tells WebMD.

There were a number of new approaches discussed here at
Digestive Disease Week, a major medical meeting of gastroenterologists.

Arthritis Medication Combats Crohn’s, too

The rheumatoid arthritis drug Humira helped patients with
moderate Crohn’s disease to go into remission, Hanauer says.

A man-made biological substance called a monoclonal antibody,
Humira works by blocking an protein called tumor necrosis
factor alpha, or TNF-alpha, that has been implicated in both rheumatoid
arthritis and Crohn’s disease.

In a study of nearly 300 patients who did not improve despite
treatment with standard medications, 30% of those given higher doses of Humira
were in remission by four weeks later, compared with only 12% on placebo,
Hanauer reports.

Humira is an injectable drug and was extremely well tolerated,
he says.

New Immune System Drug Antibody Prevents Crohn’s Flare-Ups

In another new study, the drug Antegren helped prevent
flare-ups associated with Crohn’s disease in people who were in remission,
reports Brian G. Feagan, MD, professor of medicine in the department of
epidemiology and biostatistics at the University of Western Ontario in
London.

The drug has already been shown to induce remission in Crohn’s
sufferers.

Antegren works by keeping immune system cells from leaving the
bloodstream. In Crohn’s patients, this appears to prevent the immune system
attack on the gut that occurs with the disease, Feagan says. “If we can
prevent that, white blood cells would stay in the where they
belong.”

The researchers studied 339 adults with Crohn’s disease who had
improved or gone into remission after receiving three infusions of Antegren.
The patients were randomly assigned to continue to receive Antegren for up to
12 additional monthly infusions, or to placebo.

Six months later, 44% of patients given Antegren were still in
remission, compared with 26% on placebo, Feagan says. Also, 61% of those taking
the drug continued to show an improvement in symptoms, compared with 29% on
placebo.

People who took Antegren were no more likely to suffer side
effects than those on placebo, he explains.

June 12, 2000 — The gods of sex have blessed men with Viagra, but what good is it if their female partners have lost interest?

Traditionally, men’s sexual problems have gotten the lion’s share of attention, prompting remedies from Viagra to vacuum erection pumps to penile implants. The focus has been mainly on men despite the fact that women are more likely to have sexual troubles. A survey published in the February 10, 1999 issue of the Journal of the American Medical Association found that 43% of 1,749 women had complaints about sexual functioning, compared with 31% of the 1,410 men surveyed. Subjects ranged in age from 18 to 59. The women reported low sexual desire, problems with arousal, and pain during intercourse. And these problems increase with age, experts say.

A Changing Picture

Why has research on women’s sexual dysfunction, as it’s medically known, lagged in the first place? It’s partly due to the difficulty of defining the problem. Even though impotence in men can be organic or emotional, the inability to obtain or maintain an erection is often the target for therapy. In women, sexual problems can get more . They can include, for instance, a lack of desire, lubrication, an inability to reach orgasm, or pain during intercourse. The causes can be physical, such as poor circulation, or emotional, such as stress or depression.

Finding remedies has also been a challenge because drugs that boost men’s sex lives may do nothing for women’s. A recent study of Viagra in women, released at the annual meeting of the American College of Obstetricians and Gynecologists, showed that it worked no better than a placebo in improving sexual response.

Lately, however, as have discovered more about the types and causes of women’s sexual problems, the outlook is becoming brighter. New drugs are in development specifically for women’s sexual problems. And a new clitoral suction device, meant to enhance blood flow, has been approved by the FDA.

Though many of these remedies for women’s sexual problems are months or even years away from druggists’ shelves, there are still avenues to relief right now — if a woman doesn’t give up easily and finds the right doctor.

One Woman’s Story

Peggie is one of those women who don’t give up easily. She and her husband of 25 years had always enjoyed an active sex life. Then, at age 51, she started experiencing hot flashes and, along with them, something she never expected — a loss of sexual desire.

“No one told me that when you hit menopause, forget about sex,” she says. “It was a shock to me.” Other women confided that their libidos had plummeted, too, with menopause. They told Peggie, “That’s just the way it is when women age.”

But like other women who came of age during the sexual revolution, Peggie felt that women’s sexual pleasure is as important as men’s. So she went looking for help.

, and more another.