Daily udenafil improves erectile function
MedWire News: A daily dose of udenafil 50 mg represents a "promising" option for men with erectile dysfunction, report Korean researchers.
Compared with their counterparts receiving placebo, men with erectile dysfunction treated with daily udenafil 50 mg for 12 weeks had significantly improved International Index of Erectile Function (IIEF) scores, they say.
Udenafil - a phosphodiesterase type 5 inhibitor (PDE5-I) - has a maximal concentration of 1.0-1.5 hours and a terminal half life of 11.0-13.0 hours, explain Jong Kwan Park (Chonbuk National University, Jeonju) and colleagues, in the journal European Urology. While some 'on-demand' treatment regimens for erectile dysfunction require an element of forethought, udenafil allows "relatively rapid onset and a long duration of action," adds the team.
"Planning sexual activity might be anxiety provoking for the man, his partner, and their relationship, causing the sexual encounter to become a stressful event," write Park et al.
The team evaluated the safety and efficacy of daily udenafil 25, 50, and 75 mg, versus placebo, in 237 men with erectile dysfunction treated during a 12-week period.
Positive outcomes were an improvement from baseline in IIEF scores, a positive answer to Sexual Encounter Profile (SEP) diary questions 2 ("Were you able to insert your penis into your partner's vagina?") and 3 ("Did your erection last long enough for you to complete intercourse with ejaculation?"), and the Global Assessment Questionnaire (GAQ) question "Has the treatment you have been taking.. improve your erections."
A total of 59, 59, 60, and 59 patients took placebo, udenafil 25, 50, and 75 mg, respectively. In all, 79.9% of the cohort had taken a PDE5-I previously, with no success.
Improvements in the IIEF score and the number of positive answers to question 2 of the SEP diary were significantly greater in the udenafil 50 and 75 mg groups compared with placebo, report the researchers.
Udenafil 75 mg showed greater efficacy in all subgroups except the mild and mild-to-moderate erectile dysfunction patients, whilst udenafil 50 mg had the greatest effect on this latter group.
All men taking udenafil experienced an improvement in the sexual desire domain of the IIEF, were more likely to respond positively to question 3 of the SEP diary, and answer "yes" to the question in the GAQ, compared with men taking placebo.
Udenafil was generally well-tolerated, with only mild or moderate effects noted. The most common was flushing, reported by 10 men taking any dose of the drug compared with 1 man taking placebo.
Park and co-authors conclude that further study in PDE5-I-naive patients is needed in light of the large number of participants in their study who had received prior treatment and therefore may have jeopardized the double-blind study design.
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By Sarah Guy