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Like Viagra (sildenafil), all three drugs make it easier for a man with erectile dysfunction (ED) to have an erection after sexual stimulation. But, the new drugs seem to work faster, last longer and have fewer side effects. Here's what we know:
An erection occurs only when genital blood flow is diverted into the central spongy cylinders (corpora cavernosae) of a man's penis, an event that becomes more difficult in men as they age.
Sexual arousal triggers a surge in cyclic GMP, a natural penile blood flow activator that governs the vigor of a man's erection during intercourse. After orgasm under the influence of an enzyme called phosphoediesterase-5 (PDE-5), cyclic GMP levels fall and a man's erection fades. Viagra, Cialis and Vardenafil are all PDE-5 inhibitors and work to bolster cyclic GMP levels so that a man can have a firmer, more rigid erection during sex. But, there is a difference between the drugs.
The developers of Cialis and Vardenafil have tinkered with the original molecule to come up with the next generation of erection enhancing drugs they believe offer advantages over Viagra.
Ease of Use: Viagra does not work well when taken with a big meal or after alcohol. Cialis works just as well with or without a meal and is effective even with moderate alcohol intake.
Onset of action: Patients taking Viagra are instructed to wait at least an hour before attempting to have sex. Cialis is effective within 15-20 minutes.
Duration of action: After one Viagra dose cyclic GMP levels remain elevated for several hours allowing a man to have sex that evening. The effect of Cialis and possibly Vardenafil seems to be more prolonged. After one dose of Cialis multiple episodes of sexual intercourse are possible.
Europeans have nicknamed Cialis "Le Weekend" and boast that one pill taken with wine and a hearty lunch on Friday is all a man needs to keep him sexually potent on Saturday and Sunday. But, for the mortal man a new pill each day he plans to have sex seems more realistic.
Side effects: Enzymes similar to PDE-5 react to PDE-6 inhibitors. For example, Viagra disrupts Phosphodiesterse 6 (PDE-6) a look alike color vision enzyme causing blue vision in some Viagra-treated men. Cialis has been engineered to avoid PDE-6 and does not cause blue vision.
The new PDE-5 inhibitors strengthen erections by increasing penile blood flow, but also widen blood vessels elsewhere in the body causing a small percentage of men to experience headache, nasal congestion or upset stomach. Side effects become less common with continued drug use.
Conclusion: Viagra was not just the first pill for ED, but also made it easier for us to talk about sex. With Cialis and Vardenafil even more options will be open to men with ED once they receive FDA approval. Other products are in development and there is significant progress in another long neglected little discussed problem, female sexual dysfunction. Stay tuned.
Source: Richard F. Spark, M.D., is a Senior
Attending Physician at Beth Israel Deaconess Medical Center and is an
Associate Clinical Professor of Medicine at Harvard Medical School.
Dr. Spark is the author of Sexual Health for Men: The Complete Guide.
He is also a consultant for Pfizer and Lilly ICOS
2 New Viagra Rivals Head For U.S.
Cialis: Cialis Future Competition for
Viagra Men with mild-to-severe erectile dysfunction (ED) may benefit
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Levitra: When a drug's name is designed to conjure up thoughts of men and life and its logo is a symbol of passion, it can only mean one thing: the latest would-be Viagra competitor has been christened.
It's called Levitra, the entry from Bayer AG and GlaxoSmithKline PLC into the erectile dysfunction market, which is virtually owned by Viagra. The Pfizer Inc. drug sales totaled dlrs 1.5 billion last year.
Levitra's name was to be released Monday at a medical meeting in Montreal along with data that may find its way into what is expected to be a very expensive marketing campaign set to begin next year, when the drug is introduced.
The companies declined to say how much they'll spend to promote Levitra, but the drug will get "whatever it takes" to resonate with consumers and doctors, said David Pernock, Glaxo's senior vice president and general manager of the pharmaceutical business unit.
Last year, Pfizer spent dlrs 101 million marketing Viagra to consumers, making it the fourth most heavily promoted drug in the United States. And that's when Viagra had the market all to itself. Next year, Cialis, a drug from Eli Lilly & Co and Icos Corp., is also expected to hit the market.
The battle for dominance in a condition that affects about 30 million American men - about half of them over 40 - is expected to be fierce. The new entrants will probably persuade more men to see a doctor about their problem, broadening the market, experts said.
But men are notoriously reticent about visiting doctors and generally embarrassed to discuss erectile dysfunction.
"This is a market that is driven by direct-to-consumer advertising," said Dr. Harin Pademan-Nathan, a urology professor at University of Southern California's Keck School of Medicine. "You have to spend millions to get men to the doctor."
Levitra and Cialis were both expected to be greenlighted this year but the Food and Drug Administration granted only conditional approval, seeking further study on each drug. All three drugs work in the same way so the FDA wanted to ensure the new medicines were absolutely safe and effective before granting final approval, doctors said.
Some doctors believe it will be difficult for Cialis and Levitra to establish themselves because Viagra's safety and effectiveness have been well documented in its five years on the market.
There have been no published studies which directly compare the drugs. Each marketer has a raft of data to discuss its overall effectiveness as well as usefulness in various groups, such as men with diabetes or prostate cancer. Such data is especially useful for doctors.
"None of these drugs is a major breakthrough and the biggest advantage Viagra has is that now 20 million guys have taken it," said Dr. Dominick Carbone, an assistant professor of urology at Wake Forest University.
Dr. Irwin Goldstein is excited about the prospect of having new drugs for patients where Viagra hasn't proven effective. He noted that at the International Society for Sexual and Impotence Research meeting Monday, Bayer and Glaxo will be releasing data showing that 74 percent of men taking a 20 mg dose of Levitra and 77 percent taking a 10 mg dose were able to complete penetration on their first attempt, compared with 45 percent taking placebo.
A Pfizer study found that about 55 percent of men using Viagra can complete sexual intercourse on the first try.
The FDA's conditional approval helped Pfizer, but hurt Glaxo and Lilly, both of which are struggling because some of their top-selling drugs have lost patent protection. The delay was especially painful for Bayer, which had its cholesterol lowering agent removed from the market in 2000 after it was linked to at least 40 deaths.
Those problems have contributed to Bayer's disappointing earnings and decision to lay off 13,000 people by 2005. The company also is seeking a partner for its pharmaceutical business.
"Levitra is quite important to Bayer. It is the most important drug in our pipeline for the foreseeable future and it would be nice to have it out as soon as possible," Bayer spokesman Guenter Forneck said.
Bayer developed the drug and is co-promoting it with Glaxo. The details of the arrangement have not been released but Catherine Arnold, an analyst with Sanford C. Bernstein, estimates Glaxo will eventually receive 50 percent of Levitra's profits, which she expects to reach dlrs 1 billion by 2007. She estimates it will take three years for Levitra to become profitable because of its high development and marketing costs.
It took over a year to whittle roughly 700 name candidates down to Levitra, which was formerly know by its generic name vardenafil.
Levitra is derived from "le," which is the French masculine pronoun and "vita" which is Latin for life. The flame was chosen as the logo because "it is a primal symbol for sexuality and vitality," said Robert Recobs, managing director of the New York office of Brand Institute Inc., which helped name Levitra.
The new name is the only hint of the marketing campaign. Glaxo, Bayer and Lilly all declined to comment on specific plans because FDA regulations prohibit companies from making statements about unapproved drugs.
Pfizer has used celebrity spokesmen such as Bob Dole, race car driver Mark Martin and baseball player Rafael Palmeiro to promote its product. And Lilly says it's likely to use a similar approach.
"When your target market is men 40 to 60, it is pretty clear what
your avenues for advertising are," said Matt Beebe, a Cialis brand
Vardenafil. The efficacy and tolerability of vardenafil, a new,
oral, selective phosphodiesterase type 5 inhibitor, in patients with
erectile dysfunction: the first at ...
Vardenafil. penile rigidity and tumescence. Vardenafil increases
penile rigidity and tumescence in men with erectile dysfunction after
a single oral dose by Stark S, Sachse R, Liedl T, Hensen J, Rohde
Vardenafil Significantly Improved Erectile Function in
Source: www.pharmiweb.com/News/Pressreleases/ PressRelease.asp?PRID=167
Seniorjournal.com - Move Over Viagra: Study Shows Vardenafil
Improves Erectile Function in Older Men.
Source: www.seniorjournal.com/NEWS/Aging/ 05-10-01Vardenafil.htm
Side Effects of Erectile Dysfunction
But like any medication, ED drugs may have side effects. Most reactions, such as congestion, stomach aches and headaches, are generally harmless and temporary. But in some cases, the drug works a little too well and the erection can go on for hours or even days. This may sound like every man's dream but according to Sandeep Grewal M.D., a physician with the ACE Medical Group in Rock Hill South Carolina, it's actually quite painful and can even lead to permanent muscle damage. "An erection that goes on and on is a condition known as priapism," he explains. "In rare instances the penis will turn black and the skin will peel away."
All three PDE-5 inhibitors have also been associated with compromised vision, in particular a condition known as non-arteritic ischemic optic neuropathy (NAION). Symptoms include sudden or partial blindness which usually occurs upon wakening. This is medical emergency that requires immediate attention.
About one in 200 men who take Viagra report blurry vision, a side effect that rarely occurs with Levitra or Cialis. Some Viagra users also experience blue or green tinted vision which can be permanent. Medical experts think this color disturbance may be because Viagra inhibits certain enzymes in the penis which also exist in the cone cells of the retina that are responsible for color vision. By blocking this hormone it also seems to block the perception of blue or green. Cindy Reilly, director of the practice development division for American Society of Health-System Pharmacists, notes this symptom can be predicted to some extent by examining the shape of the eye and the depth of the optic nerve -- something doctors rarely do before writing out a prescription.
Another uncommon side effect involves disturbances in the ear. In fact, Viagra, Levitra and Cialis now include warnings about sudden hearing loss and informs patients that they should seek immediate medical attention if they experience a sudden loss or decrease in hearing. In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by ringing in the ears and dizziness. In many cases, the hearing loss was permanent.
On a happier note, one side effect of Viagra is a life saver. Young children with a debilitating lung condition known as pulmonary arterial hypertension are being given the drug to lower pressure in their lungs, improving symptoms and slowing deterioration long enough until a lung transplant can be performed. "For this use it's marketed under the name Revatio because parents do not want to hear their kids are taking Viagra," Grewal says.
Reilly is quick to point out that most of the weirder reactions to
ED drugs are rare indeed, arising less than one percent of the time.
"The take home message should be for users not to exceed the
recommended dosage and if you notice something wrong, pick up the
phone and call your doctor immediately."