Vardenafil restores erectile function to normal range in men with erectile dysfunction.

Abstract

INTRODUCTION:

The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED).

AIM:

To assess the ability of vardenafil to restore normal erectile function in men with general ED.

METHODS:

In two fixed-dose, parallel-group, double-blind, placebo-controlled, pivotal studies, patients received vardenafil (5, 10, or 20 mg) or placebo for 12/26 weeks.

MAIN OUTCOME MEASURE:

In this retrospective analysis, the percentage of patients "returning to normal" erectile function at week 12 (as defined by scores > or =26 on erectile function domain of International Index of Erectile Function [IIEF-EF]) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED.

RESULTS:

Vardenafil 5, 10, and 20 mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12 weeks, compared with 10% of patients receiving placebo (P < 0.0001). Return to normal IIEF-EF domain scores was noted irrespective of severity, etiology, age, and duration of ED, and was observed even in challenging-to-treat subgroups. With vardenafil 20 mg, 39% of men with severe ED at baseline, 45-49% of men with ED of mixed or organic etiology, 35% of men aged > or =65 years, and 43% of men with ED of > or =3 years of duration returned to normal erectile function at week 12. Mean per-patient SEP3 (question 3 on the Sexual Encounter Profile) success rates in patients achieving IIEF-EF domain scores > or =26 ranged from 87% to 95%.

CONCLUSION:

Vardenafil improves the IIEF-EF domain score to the normal range in a substantial proportion of men with ED.

• Authors: Harin Padma-Nathan, Francesco Montorsi, François Giuliano, Eric Meuleman, Stephen Auerbach, Ian Eardley, Andrew McCullough, Martin Homering, Thomas Segerson, For The North American And European Vardenafil Study Group
• Journal: The journal of sexual medicine (J Sex Med) Vol. 4 Issue 1 Pg. 152-161 (Jan 2007) ISSN: 1743-6095 [Print] Netherlands
• PMID: 17233781 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Imidazoles
• Phosphodiesterase Inhibitors
• Piperazines
• Sulfones
• Triazines
• Vardenafil Dihydrochloride

Topics

• Aged
• Coitus
• Dose-Response Relationship, Drug
• Erectile Dysfunction (drug therapy)
• Humans
• Imidazoles (therapeutic use)
• Male
• Middle Aged
• Patient Satisfaction (statistics & numerical data)
• Penile Erection
• Phosphodiesterase Inhibitors (therapeutic use)
• Piperazines (therapeutic use)
• Randomized Controlled Trials as Topic
• Reference Values
• Retrospective Studies
• Severity of Illness Index
• Sulfones (therapeutic use)
• Treatment Outcome
• Triazines (therapeutic use)
• Vardenafil Dihydrochloride