title: Response to on-demand vardenafil was improved by its daily usage in hypertensive men.
abstract: OBJECTIVE
  To evaluate whether the response to on-demand vardenafil could be improved by its daily usage in hypertensive men with erectile dysfunction (ED) who previously did not answer to on-demand regime.
  
  
  METHODS
  Our main efficacy criterion was per patient percentage of positive answers on the Sexual Encounter Profile question 3 (SEP3). Carotid intima-media thickness (IMT), flow-mediated dilation (FMD), and nitrate-mediated dilation on brachial artery were considered as vascular parameters. A total of 74 hypertensive men with ED aged 50 to 70 years with no major cardiovascular disease were selected from 284 patients initially referred. After vardenafil on-demand usage during 4 weeks, patients with more than 50% of positive answers on the SEP3, or 50% and more than 6 points on the International Index of Erectile Function-Erection Function Domain (IIEF-EF) basal score or positive answer to global evaluation question were considered "responders." "Nonresponders" (n = 35) were randomized to daily vardenafil 10 mg or placebo during 5 weeks along with open 10 mg of vardenafil before intercourse.
  
  
  RESULTS
  In the active group, 38.8% of patients became responders to vardenafil (P < .05). Clinical response to continuous vardenafil correlated with sexual frequency (r = .68, P < .01), Framingham risk score (r = -.65, P < .01), carotid IMT (r = -.61, P = .01) and low-density lipoprotein (LDL)-cholesterol (r = -.64, P < .01).
  
  
  CONCLUSIONS
  Daily vardenafil during 5 weeks rescued response to on-demand regime among ED hypertensive men with no major cardiovascular disease. Further clinical trials and cost-effectiveness studies are necessary to confirm these findings.
authors.affiliation: Universidade do Estado do Rio de Janeiro, Departamento de Clinica Medica, Hospital Universitario Pedro Ernesto, State University of Rio de Janeiro, Brazil. drjavaroni2000@yahoo.com.br
authors.forename: Valter
authors.initials: V
authors.lastname: Javaroni
authors.forename: Marcio
authors.initials: M
authors.lastname: Queiroz Miguez
authors.forename: Adriana
authors.initials: A
authors.lastname: Burla
authors.forename: Wille
authors.initials: W
authors.lastname: Oigman
authors.forename: Mario Fritsch
authors.initials: MF
authors.lastname: Neves
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D001916:Brachial Artery / Q000187:drug effects / Q000502:physiology; D059168:Carotid Intima-Media Thickness; D008078:Cholesterol, LDL / Q000097:blood; D007172:Erectile Dysfunction / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D006973:Hypertension / Q000150:complications; D007093:Imidazoles / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009566:Nitrates / Q000494:pharmacology; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D013450:Sulfones / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride
chemical_list: D001786:Blood Glucose; D008078:Cholesterol, LDL; D007093:Imidazoles; D009566:Nitrates; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride