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

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 10mg 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 methodes: 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.

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.

This study showed that one in three patients had satisfactory erection for vaginal penetration in less than 15 minutes post-dosing in the real-life setting.

Expert review of clinical pharmacology. 2017 Jan 27 [Epub ahead of print]

Paolo Capogrosso, Eugenio Ventimiglia, Luca Boeri, Alessandro Serino, Andrea Russo, Giovanni La Croce, Umberto Capitanio, Federico Dehò, Francesco Montorsi, Andrea Salonia

a Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele , Milan , Italy.

email news signup