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