title: A spontaneous, double-blind, double-dummy cross-over study on the effects of daily vardenafil on arterial stiffness in patients with vasculogenic erectile dysfunction.
abstract: BACKGROUND
  It is known that the incidence of endothelial dysfunction in patients with vascular erectile dysfunction (ED) is increased. The effects of daily vardenafil on endothelial function and arterial stiffness in patients with erectile dysfunction (ED) have never been investigated.
  
  
  METHODS
  20 men complaining vascular ED (mean IIEF5=12 ± 6 and peak systolic velocity-PSV=24 ± 2 cm/s) were enrolled in a 4-week, randomized, double-blind, double-dummy, crossover study (mean age 59 ± 11) and received either vardenafil 10mg daily or 20mg on-demand with a two-week washout interval. Primary endpoints were variation from baseline of reactive hyperemia (RH) and augmentation index (AI) calculated by fingertip peripheral arterial tonometry (PAT) device. Secondary endpoints were variations of IIEF-5 and SEP3 scores from baseline and plasma surrogate markers of endothelial function, i.e. endothelin-1 (ET-1) and adrenomedullin (ADM).
  
  
  RESULTS
  Patients who took daily vardenafil (vs. on-demand) reported significant (P<0.01) improvements in arterial stiffness as evaluated by AI and reduction of plasma ADM levels (p<0.05) but no improvement in average RH. When corrected for heart rate, ADM showed a strong direct relationship with AI (r(2)=0.22; p<0.005). The proportion of patients with an IIEF5 score of ≥ 22 or in SEP3 percentage of success rates were similar. Each treatment resulted in significantly greater IIEF5 scores (p<0.001) and better SEP3 response rates (p<0.0001) compared with baseline.
  
  
  CONCLUSIONS
  We demonstrated that daily vardenafil improves arterial stiffness and erectile function measurements in men with severe vasculogenic ED. This effect may be mediated, at least in part, by a reduction in ADM circulating levels.
authors.affiliation: Department of Experimental Medicine-Medical Pathophysiology, Food Science and Endocrinology Section, University “Sapienza”, Rome, Italy. antonio.aversa@uniroma1.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Aversa
authors.forename: Claudio
authors.initials: C
authors.lastname: Letizia
authors.forename: Davide
authors.initials: D
authors.lastname: Francomano
authors.forename: Roberto
authors.initials: R
authors.lastname: Bruzziches
authors.forename: Marco
authors.initials: M
authors.lastname: Natali
authors.forename: Andrea
authors.initials: A
authors.lastname: Lenzi
mesh_terms: D053607:Adrenomedullin / Q000097:blood; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D018783:Impotence, Vasculogenic / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage*; D013450:Sulfones / Q000008:administration & dosage; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride; D059289:Vascular Stiffness / Q000187:drug effects* / Q000502:physiology; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D015415:Biomarkers; D007093:Imidazoles; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D014665:Vasodilator Agents; D053607:Adrenomedullin; D000069058:Vardenafil Dihydrochloride