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April 14, 2016Sexual MedicineOpen Access

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

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Authors

RSRidwan ShabsighRutgers, The State University of New JerseyAMA. MatternBayer (Germany)

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Overview

Prospective observational study demonstrates improved erectile function and quality of life with vardenafil in men with metabolic syndrome, highlighting its clinical utility and safety.

Key Points

  • To evaluate the safety and clinical effectiveness of vardenafil on erectile function and health-related quality of life in men with erectile dysfunction and metabolic syndrome in real-world practice.
  • International, prospective, single-arm observational study (REVITALISE) following 1,832 men newly prescribed vardenafil in routine clinical practice.
  • Treatment response was monitored over approximately 12 weeks using the International Index of Erectile Function (IIEF) and the Aging Males' Symptoms Scale.
  • In the intent-to-treat cohort (n = 1,832), 82.4% achieved the primary endpoint of an intraindividual improvement of at least four points in IIEF-EF score, with median scores rising from 15.0 at baseline to 25.0 at 12 weeks (P < .0001).
  • Following treatment, 45.4% of patients attained normal erectile function and 29.4% had mild dysfunction, alongside significant improvements in all Aging Males' Symptoms subscales (P < .0001).
  • Treatment-emergent adverse events were documented in 7.19% of participants, and no serious drug-related adverse events were reported.

Cite This Study

Shabsigh et al. (2016) studied this question.

synapsesocial.com/papers/6a8bc10a1692ae2bc0f46cbehttps://doi.org/10.1016/j.esxm.2016.03.027
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