title: Vardenafil restores erectile function to normal range in men with erectile dysfunction.
abstract: 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.
authors.affiliation: Male Clinic, Beverly Hills, CA, USA;. Electronic address: Hpn@insyght.com.
authors.forename: Harin
authors.initials: H
authors.lastname: Padma-Nathan
authors.affiliation: Istituto San Raffaele, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.affiliation: CHU de Bicetre, AP-HP, Le Kremlin-Bicetre, France.
authors.forename: François
authors.initials: F
authors.lastname: Giuliano
authors.affiliation: Afdeling Urologie, Nijmegen, The Netherlands.
authors.forename: Eric
authors.initials: E
authors.lastname: Meuleman
authors.affiliation: California Professional Research, Newport Beach, CA, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Auerbach
authors.affiliation: Leeds General Infirmary, Leeds, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Eardley
authors.affiliation: NYU Medical Center, New York, NY, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: McCullough
authors.affiliation: Bayer AG, Wuppertal, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Homering
authors.affiliation: Bayer Inc., Toronto, Canada.
authors.forename: Thomas
authors.initials: T
authors.lastname: Segerson
authors.lastname: For The North American And European Vardenafil Study Group
mesh_terms: 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
chemical_list: D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride