Journal of Andrology Study Demonstrates Drug Effectiveness
Jan 22, 2003
NewYork Weill Cornell Physician Says Drug May Raise Awareness for Treatment of Disease
A new drug shows promising results in the treatment of erectile dysfunction (ED), reports the December issue of The Journal of Andrology. A study investigator, Dr. John P. Mulhall, Director of the Sexual Medicine Program at Weill Cornell Medical Center of NewYork-Presbyterian Hospital, anticipates that the new drug will increase awareness of ED and its ability to be effectively treated.
The Journal of Andrology is the official publication of the American Society of Andrology, and is overseen and edited by Weill Cornell Medical College and The Population Council at Rockefeller University.
The new study, led by Dr. Wayne Hellstrom of Tulane University Medical Center, presents the most extensive information to date on Levitra, one of two new drugs pending FDA approval for treatment of ED. When compared to placebo, Levitra, also known by the generic name vardenafil, was shown to be effective, well-tolerated, and safe. At the highest dose, 80 percent of treated men experienced improved erections. Of men with mildly impaired erections, 89 percent returned to normal erectile function. The double-blind Phase III study involved 54 study centers and 805 patients.
Dr. Mulhall Associate Professor of Urology at Weill Cornell Medical College and Director of the Sexual Medicine Program and Associate Attending Urologist at NewYork-Presbyterian Hospital Weill Cornell Medical Center was an investigator in the study through Loyola University Chicago Stritch School of Medicine. He also provided oversight and comment on the article.
Only ten percent of men with ED are currently being treated for the condition, said Dr. Mulhall. Levitra, like Viagra, will increase awareness that erectile dysfunction is a medical condition and that there are powerful treatments now available.
The Weill Cornell Sexual Medicine Program is committed to education, treatment, and research of disorders of sexual health affecting men and women. The Program aims to improve quality of life for the patient and their partner.
Following treatment, ninety-five percent of our male patients are able to maintain erections and achieve successful penetration, said Dr. Mulhall. Two-thirds of patients respond to first-line oral therapies, such as Viagra. For those who do not respond, we offer penis injections and suppositories, as well as penile implants.
As with Viagra, Levitra pills must be taken at least one hour prior to attempts at sexual intercourse to be effective. No direct comparison of the effectiveness of Levitra versus Viagra has been published to date.
According to the American Foundation for Urologic Disease, Inc., erectile dysfunction is defined as the consistent inability to achieve and maintain an erection sufficiently to permit satisfactory sexual intercourse. It is estimated that there are 15 to 30 million men with ED in the United States, and 152-million cases of ED worldwide.
Levitra is marketed by Bayer AG and GlaxoSmithKline. The study was funded by a grant from Bayer. Dr. Mulhall is a consultant to Bayer.