Study shows PDE5 inhibitor more effective when used on-demand in erectile dysfunction

New study published in European Urology

Amsterdam, 26 August 2008 - European Urology, the official journal of the European Association of Urology will be featuring the article ‘Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy’ by F. Montorsi et al.in the October issue, showing for the first time that vardenafil, a PDE5 inhibitor, is more efficacious when used on-demand in men with erectile dysfunction, supporting a shift towards on-demand dosing with PDE5 inhibitors in this patient group. 87 centres across Europe, the US, Canada and South Africa participated between December 2004 and September 2007.

Nerve-sparing radical prostatectomy (NSRP) is the gold-standard therapy for prostate cancer in men with a life expectancy of 10 years or more. The risk of erectile dysfunction (ED) following NSRP is significant. This is caused by neuropraxia - the usually temporary failure of nerve conduction in the absence of structural changes due to compression, ischemia or blunt injury - which inevitably occurs during the procedure. Ultimately this may lead to the development of fibrosis within the corpus cavernosa and cause ED.

To prevent the onset of postoperative ED, the use of phosphodiesterase type 5 (PDE5) inhibitors was introduced. These agents prevent the breakdown of cyclic guanosine monophosphate in cavernosal tissue, which plays a role in the prevention of cell death and fibrosis, and may thus exert a protective effect on cavernosal smooth muscle.

Participants were recruited to this first robustly designed, evidence-based, multi-centre study approximately one month before they were scheduled to undergo NSRP. A total of 423 patients completed the study. The inclusion of the on-demand dosing regimen enabled comparison of the currently recommended guidelines for the use of PDE5 inhibitors with a proposed nightly dosing regimen, which was suggested to have potential positive effects on erectile function. The results clearly show that nightly dosing with vardenafil does not have any effect beyond that of on-demand use.

The study shows that on-demand use of vardenafil during the treatment period was associated with significantly greater erectile function and sexual intercourse completion rates compared to placebo. The success rates for the vardenafil on-demand group were also higher than for the nightly group. These data indicate that the use of on-demand vardenafil is of greater benefit than nightly treatment in patients following NSRP surgery and, in general, support the on-demand use of PDE5 inhibitors following NSRP surgery over a daily dosing regimen. This prompts reconsideration of the current practice of prescribing nightly PDE5 inhibitor therapy, as on-demand use of vardenafil is equally effective in men with ED following NSRP, a notoriously difficult-to-treat patient population.

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About the European Association of Urology (EAU)
The European Association of Urology (EAU) represents more than 16,000 urology professionals across Europe and worldwide. Its mission is to raise the level of urological care in Europe.
The EAU is headed by an Executive Committee (EC) and the chairmen of the EAU offices. Together they form the EAU Board. The EC is chaired by the Secretary-General who is responsible, together with the other members of the EC, for the implementation of all programmes and activities decided by the Board.
The EAU Annual Congress is the second largest urological congress in the world.
Education and postgraduate training are essential tasks of the EAU and aims at promoting quality urological education across Europe and worldwide.
Providing effective communication links to promote and disseminate scientific results and information amongst European urologists through e.g. European Urology and European Urology Today remains vital.
Finally, the EAU has special sections on the Internet, such as Uroweb and Urosource, which allows for direct communication between members.

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