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Vardenafil Improves Erectile Dysfunction Regardless of Etiology or Severity: Presented at AUA

By Ed Susman

ORLANDO, FL -- May 29, 2002 -- The experimental agent vardenafil appears to relieve the symptoms of erectile dysfunction in men regardless of the cause or severity of the condition.

"Erectile dysfunction arises from multiple etiologies and manifests from mild to severe," Dr. Craig Donatucci, MD, a urological surgeon at Duke University Medical Center, in Durham, North Carolina, United States. "In this trial, vardenafil significantly improved erectile dysfunction and was well tolerated by trial participants. It could be yet another option to effectively treat this condition."

Dr. Donatucci and colleagues studied the effects of the phosphodiesterase-5 inhibitor vardenafil and presented that findings here Monday at the 97^th annual scientific meeting of the American Urological Association (AUA).

Dr. Donatucci and colleagues reviewed the results and pooled the data from two randomized, double-blind, 12-week trials of vardenafil at dose of 5 mg, 10 mg, or 20 mg or placebo for a total of 1,357 men with erectile dysfunction.

The subjects in the study had experienced erectile dysfunction for more than six months. The primary outcome measurement was improvement in the International Index of Erectile Function (EF Domain), which was analyzed within subgroups defined by etiology and baseline severity.

Of the participants, 672 men had erectile dysfunction of organic cause, 185 men had a psychogenic caused condition, while the other 500 patients had a mixed etiology.

On the basis of the EF Domain score, 533 patients registered less than 11 points on the scale (severe dysfunction); 415 men scored 11-16 (moderate); 298 men scored 17-21 (mild-to-moderate); and 89 patients had a scored 22-25 (mild).

At the end of the 12-weeks of treatment, patients with severe disease who received placebo had a 9.1 score, significantly lower than any dose of vardenafil. Patients on the active drug had scores ranging from 14.5 to 18.3, with scores increasing as the dose increased. Similar improvements occurred for each of the groups, although only the higher doses of vardenafil were statistically better than placebo in the group with mild dysfunction.

At all dose levels, statistically significant improvements were seen over placebo for those with organic, psychogenic or mixed causes of erectile dysfunction.

The most common drug-related adverse events were headache, vasodilatation, rhinitis and dyspepsia, Dr. Donatucci said. The adverse affects appeared to be dose-related, and were mostly mild to moderate in intensity.

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