November 24, 2003.
By Amanda Gardner,
The market for erection pills, which Viagra had to itself for five years, is now, as the old saying goes, crowded.
The U.S. Food and Drug Administration on Friday approved the third pill to treat erectile dysfunction (ED), giving men and their doctors yet another option.
The newest entry, Cialis, made by Eli Lilly and Co., stays in the body much longer than its two predecessors, sometimes as long as 36 hours. This distinction has led Europeans to call it "le weekend" pill.
Cialis (also known by the generic name tadalafil) follows Viagra, which was introduced in 1998, and Levitra, which was approved earlier this year, as a boon for the 30 million American men who suffer from erectile dysfunction (ED).
The most recent FDA action follows a delay about a year ago. Observers thought Cialis was going to be approved at that time, but the FDA disappointed millions of men by asking for more studies instead, says Dr. Jed Kaminetsky, a clinical assistant professor of urology at New York University School of Medicine in New York City, who was been involved in clinical trials for Cialis and other ED drugs.
"There has been this pent-up excitement about this. I have patients asking me every day about this drug," he says.
"I think they have similar efficacy, similar safety, similar side effects," says Dr. Ira Sharlip, a San Francisco urologist and spokesman for the American Urological Association. "I think that there is a slightly greater risk of back pain and muscle pain that occurs with Cialis, but it's rarely a problem for patients. The big difference, really distinct difference, is that Cialis has a much longer duration of action, and that's what really differentiates it from the other two."
The main benefit appears to be the longer time window it allows for sexual activity. The "window of opportunity" for Viagra is about one to four hours, according to the package insert, and, for Levitra, about 15 minutes to five hours.
Patients in clinical studies for Cialis reported an effect as soon as 30 minutes after taking Cialis, which lasted up to 36 hours for some men.
Certainly, the longer time window allows for more spontaneity, but that is not always an issue. "Most people who are in a long-term relationship, there's a pattern to the way they have sex. They don't just spontaneously have sex and they don't have sex all weekend long," Kaminetsky says. "In some people, this new drug is going to be a huge advantage, and in the majority of people I think the shorter-acting drugs are going to work just fine and have worked fine."
"I don't think this drug will do anything any differently than the others other than the length of action, and I think that would be important to certain people who don't want to have to plan sex 30 to 40 minutes before they want to have sex," says Dr. Harold Fuselier, a urologist with the Ochsner Clinic FOundation in New Orleans.
The long action time is also a double-edged sword. "Yes, it does last longer," says Kaminetsky. "That will result in greater spontaneity because you can take it Friday afternoon and you'll be ready to function for the better part of the weekend. But if you have side effects, they might last a little longer."
Cialis is not recommended for men who have suffered a heart attack or stroke within the last six months, or who have very low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, or retinitis pigmentosa, an eye condition.
Cialis also should not be taken with nitrates or with an alpha blocker (a prostate drug) other than Flomax. And some patients reported side effects including headaches, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose.
Both Levitra and Cialis have an advantage over old-timer Viagra in that neither involve any food or alcohol restrictions. Viagra, by contrast, is supposed to be taken on an empty stomach or after a low-fat meal because fatty foods can inhibit absorption of the drug.
All three of the drugs work by inhibiting the enzyme phosphodiesterase 5 (PDE-5), which degrades the erection.
Overall, the picture is improving for the millions of men who suffer some form of erectile dysfunction. "All these drugs are good drugs. All work in about 80 percent of men with ED," Kaminetsky says. "They're enhancers, so men don't need to be impotent to benefit from these drugs. In fact, men who enjoy these drugs the best are men who are still potent but maybe not functioning as well as they did in the past."
"A lot of men are not interested in something that is going to last that long," Fuselier says. "It's going to be individual preference. One guy today said it works but he got the the congestion. You have to try it and see. Everybody is going to respond differently. You need to try two or three and find out which one works. Competition is healthy."
To learn more about erectile dysfunction, visit the Urology Channel or the National Institutes of Health.
Copyright © 2003 ScoutNews, LLC. All rights reserved.
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