title: Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups.
abstract: OBJECTIVE
  To assess whether vardenafil would improve erectile function irrespective of etiology, baseline severity, or patient age. The consistency of the response over time was also evaluated.
  
  
  METHODS
  A multicenter, randomized, double-blind, placebo-controlled at-home study of vardenafil treatment (5, 10, and 20 mg) was performed. This secondary analysis compared the mean International Index of Erectile Function (IIEF) erectile function domain scores of various subgroups at 12 weeks of treatment. These populations included organic, psychogenic, or mixed etiologies; mild, moderate, or severe baseline severity; and four age groups (younger than 45, 45 to 55, 56 to 65, and older than 65 years). In addition, all IIEF domains were compared at sequential 4-week periods, before and during treatment.
  
  
  RESULTS
  In the 580 men of the intent-to-treat population, the mean erectile function domain scores were statistically greater than placebo, irrespective of etiology, baseline severity, or age. This was seen at all dosages. Compared with placebo, vardenafil statistically improved the IIEF domain scores of erectile function, orgasmic function, intercourse satisfaction, and overall satisfaction after 4 weeks of treatment, and these improvements were maintained for 12 weeks. The rates of the most common adverse events (headache, flushing, and dyspepsia) were either constant or declined over time; they were generally mild to moderate and transient in nature.
  
  
  CONCLUSIONS
  Vardenafil improved erectile function regardless of the general etiology, baseline severity of erectile dysfunction, or patient age. Improvements in erectile function and other key IIEF domains were consistently seen throughout the study.
authors.affiliation: Urological Practice, Hamburg, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.forename: Jay M
authors.initials: JM
authors.lastname: Young
authors.forename: Abraham C
authors.initials: AC
authors.lastname: Schmidt
authors.forename: Jacques
authors.initials: J
authors.lastname: Buvat
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003075:Coitus; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000145:classification / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007989:Libido / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009948:Orgasm / Q000187:drug effects; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D012725:Sexual Behavior; D013450:Sulfones; D016896:Treatment Outcome; D014227:Triazines; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride