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

Abstract

IntroductionErectile dysfunction (ED) is prevalent in men with metabolic syndrome (MetS); therefore, it is important to characterize ED treatments in this population.AimsTo investigate the safety and effectiveness of vardenafil in men with ED and MetS in a clinical setting.MethodsREVITALISE 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 MeasuresThe 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.ResultsIn the intent-to-treat population (n = 1,832, mean age = 54.0 years, mean body mass index = 31.82 kg/m2, 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.ConclusionIn 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.

The effect of cardiovascular morbidity on clinical response provided by tadalafil in patients with erectile dysfunction

“…It has been reported that androgen levels decrease as the number of MetS components increase, and low testosterone level is a predictive factor for MetS and DM (Gould et al, 2007). However, these findings were not observed in other studies (Shabsigh & Mattern, 2016;Suetomi et al, 2008). Supporting this observation, there were no significant differences in our study groups in terms of testosterone levels.…”

Патогенетичні Механізми Розвитку Еректильної Дисфункції У Чоловіків, Хворих На Цукровий Діабет 1-Го Та 2-Го Типів

“…For cite: Mìžnarodnij endokrinologìčnij žurnal. 2018;14 (7):645-649. doi: 10 [5]. Повна імпотенція відзначалася у 28 % чоловіків, хворих на ЦД, у той час як у загальній популяції чоловіків вона траплялася лише у 9,6 % обстежених.…”

Corosolic acid improves erectile function in metabolic syndrome rats by reducing reactive oxygen species generation and increasing nitric oxide bioavailability

“…MetS, a cluster of metabolic derangements that are major risk factors for vascular disease, is one of the important threats to individuals with erectile dysfunction (ED). Phosphodiesterase type 5 inhibitor (PDE5i) therapy is currently the first-line treatment for ED, but some patient groups are either unresponsive to or contraindicated for PDE5i treatment (Shabsigh & Mattern, 2016). Hence, the aims of this study were to determine the underlying mechanisms of MetS related ED (MED) to provide novel therapeutic options.…”