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


OBJECTIVE
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.


METHODS
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%.


CONCLUSIONS
Vardenafil improves the IIEF-EF domain score to the normal range in a substantial proportion of men with ED.
Padma-Nathan
Harin
H
Male Clinic, Beverly Hills, CA, USA;. Electronic address: Hpn@insyght.com.
Montorsi
Francesco
F
Istituto San Raffaele, Milan, Italy.
Giuliano
François
F
CHU de Bicetre, AP-HP, Le Kremlin-Bicetre, France.
Meuleman
Eric
E
Afdeling Urologie, Nijmegen, The Netherlands.
Auerbach
Stephen
S
California Professional Research, Newport Beach, CA, USA.
Eardley
Ian
I
Leeds General Infirmary, Leeds, UK.
McCullough
Andrew
A
NYU Medical Center, New York, NY, USA.
Homering
Martin
M
Bayer AG, Wuppertal, Germany.
Segerson
Thomas
T
Bayer Inc., Toronto, Canada.
For The North American And European Vardenafil Study Group
D000368:Aged; D003075:Coitus; D004305:Dose-Response Relationship, Drug; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D010410:Penile Erection; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012016:Reference Values; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013450:Sulfones / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride