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Vardenafil Improves Erectile Function in Men with Erectile Dysfunction Irrespective of Disease Severity and Disease Classification

Authors


Craig Donatucci, MD, Duke University Medical Center, DUMC 3274, Durham, NC, USA. Tel: (1) 919 684 2127; Fax: (1) 919 681 7423; E-mail: donat001@mc.duke.edu

Abstract

Summary of Committee. Results of this study have been presented in part at the American Urological Association Meeting, May 2002, Orlando, FL (Donatucci C, Eardley I, McVary KT, Thibonnier J, and the Vardenafil Study Group. Vardenafil improves erectile function of aetiology or baseline severity in men with erectile dysfunction. J Urol 2002;167:178).

Conflict of Interest. Dr. Segerson and Mr Homering are employees of Bayer.

ABSTRACT

Background.  Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification.

Methods.  Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ).

Results.  Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37–41% of patients had severe ED, 30–34% moderate, 22% mild-to-moderate and 6–8% mild ED. At baseline, 46–51% of patients were considered to have an organic cause for ED, 13–16% psychogenic ED, and 36–38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically  significant  improvements  (P < 0.001)  in  IIEF-EF  scores,  diary  response  rates  to  the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class.

Conclusions.  Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

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