title: Time of onset of vardenafil orodispersible tablet in a real-life setting - looking beyond randomized clinical trials.
abstract: BACKGROUND
  A rapid onset of action for phosphodiesterase type 5 inhibitors (PDE5is) emerged to be of clinical importance in men treated for erectile dysfunction (ED). Data from randomized clinical trials (RCTs) showed a rapid onset of action for vardenafil 10 mg orodispersible tablet (ODT). However, the effectiveness of vardenafil ODT has never been tested in a real-life setting. We assessed the efficacy and time to onset of action of vardenafil ODT in men seeking medical help for ED in the everyday real-life clinical practice.
  
  
  METHODS
  Patients completed a baseline and follow-up International Index of Erectile Function (IIEF), along with a 8-item self-administered questionnaire about onset of action and overall treatment outcomes. Descriptive statistics tested efficacy rates, patient timing of drug intake and time to post-dosing onset of action.
  
  
  RESULTS
  Overall, 118(59.9%) patients used vardenafil ODT. Satisfactory erections for vaginal penetration were reported in 39(34.5%) and 26(21.8%), patients in =15 and =30, minutes post-dosing, respectively. Minimal Clinically Important Differences (MCIDs) criteria and Yang's criteria for responders were obtained in 80(67.8%) and 72(60.8%) patients.
  
  
  CONCLUSIONS
  This study showed that one in three patients had satisfactory erection for vaginal penetration in less than 15 min post-dosing in the real-life setting.
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Capogrosso
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Ventimiglia
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Boeri
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Serino
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Russo
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Croce
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Capitanio
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Dehò
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.affiliation: a Division of Experimental Oncology/Unit of Urology , URI-Urological Research Institute, IRCCS Ospedale San Raffaele , Milan , Italy.|b Università Vita-Salute San Raffaele , Milan , Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Salonia
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome; D000069058:Vardenafil Dihydrochloride / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D013607:Tablets; D000069058:Vardenafil Dihydrochloride
keywords: Erectile dysfunction; phophodiesterase type 5 inhibitors; time to onset; vardenafil