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FOR IMMEDIATE RELEASE: MAY 25, 2002
Media Contacts Only: Bill Seiler bseiler@umm.edu 410-328-8919
Ellen Beth Levitt eblevitt@umm.edu 410-328-8919
Urologists at the University of Maryland Medical Center have developed a simple strategy to restore normal sexual function to many men who initially fail to respond to Sildenafil (Viagra) therapy.
In a study of 253 men, University of Maryland urologists found that with clear instruction on how and when to use the medicine, proper dosing levels and information about the drug's safety, about 40 percent of the men could achieve the desired results. All of the men studied had been prescribed Viagra by their primary care physicians to correct erectile dysfunction, but it had not helped.
The University of Maryland urologists will describe the results of their study today (May 25) at the American Urological Association's scientific meeting in Orlando, Florida.
"Our findings give hope to men who tried Viagra, but concluded it wouldn't work for them," says one of the authors of the report, Geoffrey N. Sklar, M.D., a urologist at the University of Maryland Medical Center and associate professor of surgery at the University of Maryland School of Medicine.
Erectile dysfunction is the inability to achieve or maintain an erection. Some men experience chronic, complete erectile dysfunction (impotence) while others achieve only partial or brief erections. The condition has many causes, most of which are treatable, and is not an inevitable consequence of aging.
The study followed 253 men who were referred to the urologists after they had tried Viagra but did not respond. On their first visit, patients were asked to fill out a standard diagnostic questionnaire, the Sexual Health Inventory for Men. They also viewed a brief instructional videotape about erectile function and were given handouts with statements about the safety of Viagra and instructions on how to use it.
Each patient then spent an average of 12 minutes with the urologist for an examination and a review of their medical history to look for risk factors and conditions that might rule out the use of Viagra. Patients who could safely take the drug left the office with samples of Viagra and a prescription.
The urologists found that 17 of the men should not have been prescribed Viagra in the first place, because they were using either nitroglycerine tablets or patches, or had cardiac or liver contraindications. Of the 236 remaining patients, 98 of them, or 41.5 percent, responded successfully to the Viagra after the visit. These men were followed for about two years after their initial refer
Dr. Sklar says many of these men were anxious about their situation. They may not have listened closely when their doctor first told them how to use the drug, or the instructions may have been inadequate.
"Some of the men had taken the Viagra after a heavy meal, which interferes with the absorption of the medication. Others took the wrong dose, or they expected results too soon after taking the pill. Still others overlooked the role of sexual stimulation in providing an erection. And some men gave up on the drug after trying it just one time," says Dr. Sklar.
An instruction sheet, developed by Dr. Sklar, tells the patient to take the pill approximately one hour prior to sexual stimulation, on an empty stomach or after a low fat meal. It also advises avoiding alcohol consumption and trying the pill multiple times. The sheet concludes, "Show this information and instructions to your sexual partner."
Dr. Sklar says in 1999, when the study began, Viagra packaging did not contain detailed recommendations on how to use the drug effectively. Many of the instructions used in the Baltimore study are now included in the new Viagra packaging, according to Dr. Sklar.
Proper dosing is also important. In this study, 31 percent of the patients responded to the standard first dose of 50-milligrams (mg). But 69 percent of the men required a 100-mg dose to elicit a response. The study also found that the typical patient needed to try Viagra six-to-eight times before the maximum effect was achieved.
At a mean follow-up of 22 months, 91% of the men continued to respond to the medication. Those who did not respond required additional therapies, such as injections, vacuum pumps or surgery to correct their dysfunction.
Dr. Sklar says the study indicates that doctors can help more patients by simply providing some educational materials. He adds that early diagnosis of erectile dysfunction can lead to a better response to Viagra. The best response came from patients whose dysfunction had persisted for less than two years.
Michael J. Szostak, M.D., a urology resident at the University of Maryland Medical Center, assisted Dr. Sklar in the study, which was not funded by any pharmaceutical company.
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