PROVEN study shows success with Levitra

Men with ED taking Levitra reported significant improvement in erectile function

The first clinical study to evaluate Levitra (vardenafil HCl) in men with erectile dysfunction (ED) who were unresponsive by history to Viagra (sildenafil citrate) showed that these men were three times more likely to complete sexual intercourse successfully on Levitra than on placebo.

'In my clinical experience, a number of men with ED are not successful with Viagra. Results from the PROVEN Results from the study, referred to as the PROVEN (Patient RespOnse with VardENafil in Silde-nafil Non-Responders) study clearly demonstrated that Levitra was effective in many men who reported lack of success with Viagra,' said Culley Carson, III, MD, lead study investigator.

'These findings confirm the need for new treatments and support Levitra as an excellent choice for many men with ED.' Dr Carson is chief of Urology at the University of North Carolina Hospital, Chapel Hill, and Rhodes distinguished Professor of Urology.

This prospective, multicenter, double-blind, flexible-dose trial studied men with ED who had a documented history of non-response to Viagra. Unresponsiveness to Viagra was defined by patient reported history and they were not re-challenged with Viagra.

All study participants met rigorous criteria, including failing at least four of the last six attempts at successful intercourse with Viagra and having at least one unsuccessful attempt with the highest available dose of Viagra (100 mg). These men were considered to be unresponsive to Viagra in the medical opinion of the study physician. A total of 463 men with moderate to severe ED were randomised to Levitra 10 mg or pla-cebo for four weeks. At weeks four and eight of the trial, physicians could adjust the starting dose of Levitra 10 mg to 20 mg or 5 mg based on the efficacy and tolerability of the drug.

All primary endpoints showed statistically and clinically significant improvements compared with placebo. Results showed that after 12 weeks, men were three times more likely to complete sexual intercourse successfully on Levitra than on placebo (46.1% vs. 16.1%, respectively). When compared with baseline, men were four times more likely to complete sexual intercourse successfully on Levitra (46.1% vs. 10.1%, respectively). Among those taking placebo, there were no clinically or statistically significant differences in success in maintaining erections to completion of successful intercourse after taking the sugar pill as compared with baseline (16.1% vs. 11.6%, respectively).

Other studies have shown that Levitra works as quickly as 15 minutes (most men by 25 minutes), is effective from the first time that most men take it, and provides a reliable improvement in erection quality for many men with ED.