Time of onset of vardenafil orodispersible tablet in a real-life setting–looking beyond randomized clinical trials

P Capogrosso, E Ventimiglia, Luca Boeri, A Serino, A Russo, Giovanni La Croce, U Capitanio, F Dehò, F Montorsi, A Salonia

Research output: Contribution to journalArticlepeer-review

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. Research design and 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. © 2017 Informa UK Limited, trading as Taylor & Francis Group.
Original languageEnglish
Pages (from-to)339-344
Number of pages6
JournalExpert Review of Clinical Pharmacology
Volume10
Issue number3
DOIs
Publication statusPublished - 2017

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