title: Vardenafil in men with stable statin therapy and dyslipidemia.
abstract: BACKGROUND
  Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for their efficacy and safety in various clinical trials in men with erectile dysfunction (ED) with or without associated comorbidities.
  
  
  OBJECTIVE
  This is the first prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a PDE-5 inhibitor (i.e., vardenafil) in an exclusive population of men with ED and dyslipidemia.
  
  
  METHODS
  Three coprimary efficacy measurements (Sexual Encounter Performance [SEP]2, SEP3, International Index of Erectile Function-Erectile Function [IIEF-EF] domain scores) were used to assess the differential effect of vardenafil vs. placebo in this patient population. Adverse events (AEs) safety data were obtained to compare safety outcomes.
  
  
  METHODS
  This 12-week of randomized, double-blind, placebo-controlled study was conducted in 59 U.S. centers. Patients received either on-demand, flexible-dose vardenafil 10 mg (titrated to 5 mg or 20 mg based upon efficacy and safety) or placebo.
  
  
  RESULTS
  Of the 712 patients screened and entered into the study, 395 were randomized. Baseline demographics for the intent-to-treat population included: mean age, 54.4 years (+/-7.5 standard deviation [SD]); 76% Caucasian; mean body mass index (BMI), 31.7 kg/m(2) (+/-12.7 SD); 47% past/present smoker; and 42% severe ED. Aside from dyslipidemia, other comorbidities included hypertension, 61%; obesity (i.e., BMI >/= 30), 51%; and type 1 or 2 diabetes, 40%. During the 12-week treatment period, the least squares (LS) adjusted mean success rates in patients on vardenafil vs. placebo were: SEP2, 79.09% vs. 51.92%; and SEP3, 66.69% vs. 33.83% (P < 0.001). The LS adjusted mean IIEF-EF domain score for week 12 using LOCF was 21.99 in patients on vardenafil therapy vs. 14.83 in those on placebo (P < 0.001). The most commonly encountered AEs were headache and nasal congestion.
  
  
  CONCLUSIONS
  Vardenafil was demonstrated to be safe and effective for managing ED in men with ED and associated dyslipidemia. The results of this study support the role of expanded research on outcomes related to effective ED treatment and aggressive lipid control.
authors: Clinical Associate Professor of Family Medicine, Brown University School of Medicine, Swansea, MA, USA. Martin_Miner@Brown.edu
authors: Martin
authors: M
authors: Miner
authors: Larry
authors: L
authors: Gilderman
authors: James
authors: J
authors: Bailen
authors: David
authors: D
authors: Cook
authors: Katie
authors: K
authors: Dawson
authors: Marisha
authors: M
authors: Stanislaus
authors: Eric
authors: E
authors: Beresford
authors: Allison
authors: A
authors: Barnes
mesh_terms: D003075:Coitus; D003920:Diabetes Mellitus / Q000453:epidemiology; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000188:drug therapy* / Q000453:epidemiology; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006973:Hypertension / Q000453:epidemiology; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D013450:Sulfones / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology; D000069058:Vardenafil Dihydrochloride
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride