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New impotence drugs: In the zone?

The recently released impotence drug Levitra has had enormous success, although doctors say there is little difference between Levitra and market leader Viagra. Still many health experts hope the drug’s arrival could help end the stigma of impotence.
The drug Levitra, shown here, is one of several new pharmaceutical options for men struggling with impotency.
The drug Levitra, shown here, is one of several new pharmaceutical options for men struggling with impotency.
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The Chicago office of urologist Dr. Kevin McVary has been crowded over the last month with men anxious to try the new erectile dysfunction drug, Levitra. McVary’s patients — many of whom were disappointed by their experiences with the so-called wonder drug Viagra — have high hopes the little orange pill that just hit the market will help them with their impotence problems.

“All those guys are coming in looking for the magic bullet,” said McVary, associate professor of urology at Northwestern University in Evanston, Ill. “Many men who failed with Viagra are wondering if Levitra will be better, if there will be fewer side effects.”

McVary estimates that the number of prescriptions he’s written for the new drug outnumber requests for Viagra by five-to-one, a result of the multi-million-dollar marketing blitz from Levitra’s manufacturers Bayer and GlaxoSmithKline.

But Dr. James Cummings, director of urology at St. Louis University School of Medicine, hasn’t yet written any prescriptions for the new drug. None of his male patients have requested it, so the urologist continues to give out free samples and prescriptions of Viagra, the little blue pill that has revitalized the sex lives of millions of men for the last 5 years.

“I don’t see any reason to recommend Levitra and nobody has asked for it by name,” Cummings said.

While some doctors like Cummings see enzyme-blockers such as Levitra (vardenafil HCl) and Viagra (sildenafil citrate) as “basically interchangeable” in the way they treat erectile dysfunction, the newcomer is off to a blockbuster start in the United States following its approval by the Food and Drug Administration in August. In less than a month, Levitra captured half of all new prescriptions written for impotence problems.

An end to the stigma?
Levitra’s out-of-the-gate success says as much about the widespread nature of erectile dysfunction as it does about the racy advertising that’s accompanied the tablet’s arrival.

For example, in one Levitra commercial a handsome 40-something man repeatedly tries to throw a football through a tire hanging from a tree. When he finally succeeds, he’s joined by a beautiful, smiling woman. The voice-over says, “Sometimes you need a little help staying in the game. When it gets in the zone, it’s good.”

Even though the phenomenal publicity around Viagra has made it synonymous with sexual potency, most men who suffer erection problems don’t get help for them.

Over half of all males between 40 and 70 years of age experience erectile dysfunction, making it the most common chronic condition affecting men. ED can be caused by diabetes, blood pressure medications, prostate cancer surgery or numerous other conditions.

Whether because of embarrassment or lack of information about treatment, as many as 90 percent of men with the condition don’t get help, experts say.

“One of the most difficult things for a doctor is to ask patients about their sexual health,” said Cummings.

That’s why doctors are supportive of Levitra. Whatever gets those men who can’t throw the football through the tire to ask their doctors for help is good thing, they say.

“The more marketing there is, the more normalizing it is,” says Dr. Drogo Montague, an expert on male sexual health at The Cleveland Clinic. “It says that erectile dysfunction is just another medical condition. That’s all good.”

McVary agrees that Levitra’s arrival could help end the stigma of impotence.

“There will be more talk about the condition and less reluctance for men to seek help,” he said.

Viagra was hailed as a medical miracle for older men when it landed on pharmacy shelves in 1998. Not since the launch of the birth control pill had there been an event with such a revolutionary impact on sexual behavior, Dr. Abraham Morgentaler writes in his new book, “The Viagra Myth.”

But as much as Viagra did to kick start many men’s erections, it also left plenty of dashed expectations.

Half of men who were given Viagra prescriptions never refilled them, either because the drug didn’t work for them or they took it incorrectly, said Morgentaler, a urologist who specializes in sexual dysfunction at Harvard Medical School.

Then there are the men who got erections with Viagra, but realized the results weren’t what they were expecting.

“Viagra helps blood flow to the penis, but it doesn’t create intimacy, love or desire,” said Morgentaler. “We have a tendency to look for the quick-fix. But for many patients, even if it helps in some ways, it can create dashed expectations.”

Or as McVary sees it, “Some men want the ability to have an erection and it works, but sex isn’t as great as they remember it.”

Similar effects
Will a man who didn’t get consistent erections with Viagra get lucky with Levitra?

“We don’t know because we haven’t tried it, but we expect them to work the same,” said Montague. “If a man had an adequate trial of Viagra and it didn’t work, in all probability, Levitra won’t work either.”

The two drugs haven’t been tested head-to-head yet, but now that Levitra is being marketed in the United States, doctors expect studies will be conducted to compare their effectiveness.

Viagra and Levitra have similar chemical structures and function in very similar ways. They also cost about the same — $8 to $10 per tablet.

Both take effect within a half-hour to an hour after taking the medication and last about 4 to 6 hours. Viagra’s absorption can be slowed by large meals while Levitra seems to be less affected by food.

For some men, Viagra’s side effects of bad headaches, indigestion and blue-tinged vision were enough to turn them off the drug.

Because Levitra is so new to the market, its side effects haven’t been fully noted yet, although clinical trials report flushing, nausea and headaches.

Men who take medicines for hypertension or other heart problems such as alpha-blockers or nitrates shouldn’t use either Viagra or Levitra, the manufacturers caution.

More choices on the way
If Levitra and Viagra aren’t enough, there’s more hope on the way for American men. A long-lasting drug called Cialis is expected to get FDA approval by the end of the year.

Cialis (tadalafil) is already available in 42 countries, including Britain, Mexico and Australia. Like Viagra and Levitra, Cialis encourages blood flow to the penis, but it’s been amusingly nicknamed the “weekender” because it’s supposed to last for 24 to 36 hours — approximately four times longer than Viagra or Levitra.

In other countries, Cialis manufacturer Eli Lilly & Co. promotes the yellow, almond-shaped pill as the solution for men who value spontaneity and want less pressure to perform within a short period of time.

“Spontaneity is a problem for men with erectile dysfunction,” writes Morgentaler in “The Viagra Myth.”

An independent study released in September by a German urologist directly compared Cialis and Viagra. Of 226 men who completed the study, 66 percent patients preferred Cialis to Viagra, mainly because of the duration of its effectiveness and fewer side effects. Erectile function was comparable in men using both drugs, regardless of their preference, the researchers said.

Another drug, called Uprima (apomorphine hydrochloride), which has been available in Britain and Europe for the last 2 years, mimics the effect of dopamine, one of the brain’s main chemical messengers. It’s been called the “thinking man’s Viagra” because it works on the brain and nervous system to trigger an erection rather than stimulating blood flow to the penis.

Uprima’s future in the United States looks doubtful. Its manufacturer, TAP Pharmaceutical Products, a joint venture of Abbott Laboratories and Takeda Chemical Industries Ltd., failed to win FDA approval of the tablet, which is dissolved under the tongue just before intercourse. The government agency had previously denied the drug’s approval because some men who tested the optimal dose fainted or suffered severe low blood pressure.

The company said it would not try again for approval in the United States.

For the time being, Viagra and its new rivals remain the most effective drugs to treat ED, doctors say.

“This whole class of drugs has been a major advance in that it has really allowed a lot of patients who may have been afraid to get treated to get out of their depression,” said Cummings. “The men who take [Viagra or Levitra] and it works for them are extremely grateful patients.”