title: Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age.
abstract: OBJECTIVE
  To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups.
  
  
  METHODS
  In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) "Has the treatment you have been taking over the past 4 weeks improved your erections?'. The 1385 men were grouped by age (< 45, 45-64 and > or =65 years).
  
  
  RESULTS
  At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged > or = 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45-64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in approximately 71%, 76% and 85% of men aged <45, 45-64 and > or = 65 years (P < or = 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age.
  
  
  CONCLUSIONS
  Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.
authors.affiliation: Department of Urology, CHU de Bicêtre, AP-HP, 78 rue du Général Leclerc, 94272 Le Kremlin Bicêtre Cedex, France. giuliano@cyber-sante.org
authors.forename: François
authors.initials: F
authors.lastname: Giuliano
authors.forename: Craig
authors.initials: C
authors.lastname: Donatucci
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.forename: Stephen
authors.initials: S
authors.lastname: Auerbach
authors.forename: Gary
authors.initials: G
authors.lastname: Karlin
authors.forename: Christiane
authors.initials: C
authors.lastname: Norenberg
authors.forename: Martin
authors.initials: M
authors.lastname: Homering
authors.forename: Thomas
authors.initials: T
authors.lastname: Segerson
authors.forename: Ian
authors.initials: I
authors.lastname: Eardley
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013450:Sulfones; D016896:Treatment Outcome; D014227:Triazines; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride