title: The SIAMS-ED Trial: A National, Independent, Multicentre Study on Cardiometabolic and Hormonal Impairment of Men with Erectile Dysfunction Treated with Vardenafil.
abstract: Increased cardiovascular risk has been associated with reduced response to proerectile drugs. The Italian Society of Andrology and Sexual Medicine (SIAMS) promoted an independent, multicenter study performed in 604 men (55 ± 12 yrs) suffering from erectile dysfunction (ED) to assess multiple health outcomes and response to 6-month vardenafil challenge in a real-life setting. Overall, 30.8% men had metabolic syndrome. Cardiovascular risk stratification revealed a greater number of ED subjects with moderate risk of a major adverse cardiovascular event than the general population (P < 0.01). Age-adjusted pulse pressure was positively correlated with ED severity and negatively with androgens and waist circumference (P < 0.01). A decline in total testosterone was observed with increasing arterial pulse pressure (P < 0.05), which was not accompanied by compensatory LH rise. Follow-up on 185 men treated with vardenafil in an nonrandomized, open, single-arm trial documented a significant rise in IIEF-5 (delta = 6.1 ± 4.8) that was maintained in men with high cardiovascular risk. Mild adverse events occurred in <5%, with no differences between cardiovascular risk classes. In summary, ED is a frequent symptom in patients with an elevated, but often unknown, risk of future cardiovascular events. Androgens predict vascular resistance in ED patients. Vardenafil's response and safety profile were preserved in subjects with higher cardiovascular risk.
authors: Department Experimental Medicine, Sapienza University, 00161 Rome, Italy.
authors: Andrea M
authors: AM
authors: Isidori
authors: Endocrinology Unit, Maggiore-Bellaria Hospital, 40133 Bologna, Italy.
authors: Giovanni
authors: G
authors: Corona
authors: Department Experimental Medicine, Sapienza University, 00161 Rome, Italy.
authors: Antonio
authors: 0000-0002-2989-2618
authors: A
authors: Aversa
authors: Department Experimental Medicine, Sapienza University, 00161 Rome, Italy.
authors: Daniele
authors: D
authors: Gianfrilli
authors: University of Tor Vergata, Department of System Medicine, 00133 Rome, Italy.
authors: Emmanuele A
authors: EA
authors: Jannini
authors: Centre Cryopreservation of Male Gamete, University of Padova, 35122 Padua, Italy.
authors: Carlo
authors: C
authors: Foresta
authors: Biomedicine, University of Florence, 50121 Florence, Italy.
authors: Mario
authors: 0000-0001-5027-4446
authors: M
authors: Maggi
authors: Department Experimental Medicine, Sapienza University, 00161 Rome, Italy.
authors: Andrea
authors: A
authors: Lenzi