The real-life perception of efficacy, attitude, satisfaction and safety of vardenafil therapy (REPEAT): a prospective, non-interventional, observational study. (June 2014) - Hartmann, Uwe
Abstract This study assessed the improvement in relationship quality, effectiveness and safety associated with vardenafil for the treatment of erectile dysfunction (ED). The study was conducted in 1433 centres across 21 countries and comprised a baseline patient visit and up to four follow-up visits during an observational period of 1 year. Relationship quality, happiness, satisfaction with vardenafil treatment, and safety and tolerability were assessed by physician interviews and patient and partner questionnaires. Overall, 7496 patients were enrolled in the study, of which 7430 were included in the safety analyses and 6470 in the effectiveness analyses. Relationship quality, assessed by a relationship questionnaire (partnerschaftsfragebogen [PFB]), was improved at last observation carried forward, compared with baseline, in both patients and partners and satisfaction with the effectiveness of vardenafil treatment was high. Vardenafil was well tolerated and adverse events were consistent with the known safety profile of phosphodiesterase type 5 inhibitors. These results confirm the well-established effectiveness and safety profiles of vardenafil. This study is the first to demonstrate improvements in relationship quality following vardenafil therapy, in both patients and partners, using the PFB questionnaire.