VARDENAFIL IMPROVES ERECTILE FUNCTION REGARDLESS OF ETIOLOGY OR BASELINE SEVERITY IN MEN WITH ERECTILE DYSFUNCTION
Erectile dysfunction (ED) arises from many etiologies and may be mild to severe. A recent phase IIb trial showed that vardenafil improved erectile function regardless of etiology or baseline severity. We determined the efficacy and safety of vardenafil with respect to etiology and baseline severity in a pooled analysis of data from 2 randomized, double-blind, phase III trials. Men who had had ED for less than 6 months received 5, 10 or 20 mg. vardenafil, or placebo for 12 weeks. The International Index of Erectile Function (EF Domain) was analyzed within subgroups defined by etiology, including organic ED in 672 men, psychogenic ED in 185 and mixed ED in 500. Baseline severity according to the EF domain score was severe in 533 men, moderate in 415, mild to moderate in 298 and mild in 8. Regardless of etiology or dose, vardenafil improved ED in statistically significantly fashion. ED was also statistically significantly improved by vardenafil regardless of baseline severity. Most significantly, after vardenafil treatment, severe ED improved to the mild-to-moderate range. Vardenafil was well tolerated. The most common drug related adverse events, namely headache, vasodilatation, rhinitis and dyspepsia, were related to the dosage and mostly mild to moderate. Vardenafil significantly improved ED regardless of etiology or severity, especially in men with severe ED.
Additional resources on erectile dysfunction are available from MayoClinic.com:
http://www.mayoclinic.com/health/erectile-dysfunction/DS00162
Craig Donatucci*, Durham, NC; Ian Eardley, Leeds, UK; Kevin T McVary, Chicago, IL; Marc Thibonnier, West Haven, CT
