Poster Session 6: External genital| Volume 8, ISSUE 8, P600, September 2009

N90 The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study – results from 2543 Polish patients

      Introduction and Objectives

      To appraise the efficacy, safety and patient acceptability of vardenafil under real-life conditions in routine treatment of erectile dysfunction. The secondary aim was to evaluate the influence of the treatment on depressive symptomatology and self-esteem in men with erectile dysfunction.

      Material and Methods

      This was a prospective, open, uncontrolled, non-interventional, post-marketing, surveillance study. The observation period for each patient intakes over one month. For every subject investigator had to collect data at an initial and control follow-up visit. A patient questionnaire (PQ) together with CES-D and Rosenberg Scale questionnaires were used. 2543 patients were enrolled. As 2471 patients attended to initiating and at least one control visit they were included in intent-to-treat statstical analysis population.


      Overall erectile improvement was reported by 94.5% of the subjects. Effectiveness varied depending on severity, etiology and duration of the disorder as well as on the age of the patient. Penetration was possible in 96.8% of all sexual attempts documented in PQs. In 88.3% of endeavours the erection could be maintained long enough to complete intercourse. There was a significant improvement in frequency of depressive symptomatology during the observation in overall score of CES-D. Percentage of patients who presented with depressive symptoms decreased from 59.33% to 36.58% at initial vs. control visit respectively. Adverse drug reactions were were very rare – 0.45% patients. The most frequent were flushing and headache.


      In this observational study Levitra was generally well tolerated and highly effective treatment of mild, moderate and severe ED of varying etiology.