By Jill Stein
LYON, France -- November 16, 2009 -- Men with mild erectile dysfunction (ED) can achieve substantial clinical benefit from treatment with sildenafil, according to results of the open-label extension phase of an 8-week trial presented at the 12th Congress of the European Society for Sexual Medicine (ESSM).
Most of the 152 men enrolled in the 6-week open-label extension trial reported improved erections, and about two-thirds of erections were completely hard and rigid, noted Serge Carrier, MD, McGill University, Montreal, reporting here on November 16.
At the start of the 8-week, double-blind, placebo-controlled phase of this trial, all men had mild ED defined as a score of 22 to 25 on the Erectile Function domain of the International Index of Erectile Function (IIEF). Erectile dysfunction had been present for at least 3 months.
In the open-label phase of this trial, the starting dose of sildenafil was 50 mg, and could be adjusted to 25 or 100 mg. Treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The EDITS was calculated by multiplying the average EDITS item score by 25, and the EDITS was classified as satisfied (score >50) versus unsatisfied (score <=50).
The study found that at the end of open-label treatment, the EDITS score had increased, and 93% of patients were satisfied with sildenafil treatment. The mean score was 86. These results demonstrated a high degree of treatment satisfaction.
In addition, the mean scores for all IIEF domains were significantly improved at the end of the open-label phase compared with the scores at the end of the double-blind treatment phase (P <= .001).
Most adverse events were mild to moderate in severity.
"Very few studies have prospectively assessed a population of men with mild ED," Dr. Carrier pointed out. "Mild ED may affect quality of life as much as moderate or severe ED."
This study excluded men who had previously used 4 or more doses of any phosphodiesterase type 5 inhibitor within the past 12 weeks or any dose within the past 4 weeks.
Funding for this study was provided by Pfizer Canada Inc.
[Presentation title: Men With Mild Erectile Dysfunction Benefit From Sildenafil Treatment. Abstract PO-05-006]
E-Mail this DGDispatch to a colleague
