title: The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men.
abstract: BACKGROUND
  In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed.
  
  
  METHODS
  In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions.
  
  
  RESULTS
  The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient.
  
  
  CONCLUSIONS
  In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.
authors.affiliation: Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, 77 Mitropoleos str., 546 22 Thessaloniki, Greece. hatzichr@med.auth.gr
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Hatzichristou
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.forename: Jacques
authors.initials: J
authors.lastname: Buvat
authors.forename: Nicole
authors.initials: N
authors.lastname: Laferriere
authors.forename: Tiemo-Joerg
authors.initials: TJ
authors.lastname: Bandel
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
mesh_terms: D007172:Erectile Dysfunction / Q000188:drug therapy*; D005060:Europe; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D011446:Prospective Studies; D013450:Sulfones; D011795:Surveys and Questionnaires; D014227:Triazines; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride