REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome

INTRODUCTION: Erectile dysfunction (ED) is prevalent in men with metabolic syndrome (MetS); therefore, it is important to characterize ED treatments in this population. AIMS: To investigate the safety and effectiveness of vardenafil in men with ED and MetS in a clinical setting. METHODS: REVITALISE is an international, prospective, single-arm, observational study in men with ED and MetS newly prescribed vardenafil. Vardenafil was prescribed at the discretion of the treating physician in line with the marketing authorization. Treatment effectiveness (International Index of Erectile Function [IIEF]) and health-related quality of life (Aging Males' Symptoms Scale) were assessed at treatment initiation, at an optional dose adjustment visit after approximately 4 weeks, and at the end of the observation period (approximately 12 weeks). MAIN OUTCOME MEASURES: The primary outcome was an intraindividual improvement in erectile function (EF), defined as an increase of at least four points in the EF domain of the IIEF. Secondary outcomes included assessing normal EF (IIEF-EF score ≥ 26), mild ED (IIEF-EF score = 22–25), and health-related quality of life. Treatment-emergent adverse events were monitored. RESULTS: In the intent-to-treat population (n = 1,832, mean age = 54.0 years, mean body mass index = 31.82 kg/m(2), Asian 36.8%, white 49.9%, 20.4% with severe ED, 75.6% with mild or moderate ED, 4.0% without ED), 82.4% reported an increase of at least four points in IIEF-EF score. Median IIEF-EF score increased from 15.0 (baseline) to 25.0 at 12 weeks (P < .0001). After treatment, 45.4% and 29.4% (intent-to-treat population) had normal EF and mild ED, respectively. Improvements in the sexual, psychological, and somatic subscales of the Aging Males' Symptoms Scale were found (P < .0001). Treatment-emergent adverse events were reported by 7.19% of patients; there were no serious adverse events related to vardenafil. CONCLUSION: In a clinical setting, men with ED and MetS treated with vardenafil reported improvements in EF and health-related quality of life; and the safety profile of vardenafil was acceptable. REVITALISE demonstrates that vardenafil represents a good treatment option for men with ED and MetS.