BOSTON -- September 20, 2006 – Research published in The Journal of Sexual Medicine and presented at the 12th World Congress of the International Society for Sexual Medicine in Cairo, Egypt is unique in that the data is from a head to head trial of PDE5 inhibitors used to treat patients with erectile dysfunction (ED), designed to minimize bias toward either study drug. The study was a randomized, double-blind, crossover, head-to-head clinical trial that compared vardenafil and sildenafil treatment in men with ED and diabetes, hypertension, and/or hyperlipidemia. The results demonstrated that vardenafil achieved nominal statistical superiority over sildenafil for several frequently used efficacy measures, and non-inferiority of vardenafil to sildenafil as measured by various assessments of patient satisfaction and patient preference.
A total of 1,057 men participated in the study, which involved treatment using each drug for four weeks, with a one-week washout period in between. Patients were asked: "Overall, which medication do you prefer?" along with 11 other preference questions relating to their ED treatment. Additional efficacy assessments using established scales were also used in analysis.
Data showed that 38.9% preferred vardenafil compared to 34.5% sildenafil (26.6% had no preference). Vardenafil was significantly superior to sildenafil in terms of erectile function, intercourse satisfaction and overall satisfaction. There were also a significant higher percentage of positive responses for vardenafil with regards to erection hardness for penetration, maintenance of erection, maintenance until completion, and erection confidence.
"This study represents an important step forward in our understanding of the clinical differences between PDE5 inhibitors, confirming the efficacy of vardenafil for men with erectile dysfunction," explains Irwin Goldstein, study co-author and Editor-in-Chief of The Journal of Sexual Medicine.
There are currently three PDE5 inhibitors available to treat ED: sildenafil, tadalafil and vardenafil, all of which have previously demonstrated efficacy and tolerability in a range of patient populations, according to researchers.
Data from head-to-head clinical trials, like this one, are scarce. However, results from studies such as this should help clinicians to differentiate among sildenafil, vardenafil, and tadalafil and to select the most appropriate for individual patients.
This study is published in The Journal of Sexual Medicine . Media who would like to receive a PDF of the study should contact: medicalnews@bos.blackwellpublishing.net.
The Journal of Sexual Medicine publishes multidisciplinary basic science and clinical research to define and understand the scientific basis of male and female sexual function and dysfunction. As the official journal of the International Society for Sexual Medicine, it provides healthcare professionals in sexual medicine with essential educational content and promotes the exchange of scientific information generated from experimental and clinical research. For more information visit: www.blackwellpublishing.com/jsm.
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The Journal of Sexual Medicine