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International Journal of Endocrinology
Volume 2014, Article ID 858715, 13 pages
Clinical Study

The SIAMS-ED Trial: A National, Independent, Multicentre Study on Cardiometabolic and Hormonal Impairment of Men with Erectile Dysfunction Treated with Vardenafil

1Department Experimental Medicine, Sapienza University, 00161 Rome, Italy
2Endocrinology Unit, Maggiore-Bellaria Hospital, 40133 Bologna, Italy
3University of Tor Vergata, Department of System Medicine, 00133 Rome, Italy
4Centre Cryopreservation of Male Gamete, University of Padova, 35122 Padua, Italy
5Biomedicine, University of Florence, 50121 Florence, Italy
6SIAMS, Italian Society of Andrology and Sexual Medicine, Italy

Received 15 September 2013; Revised 8 December 2013; Accepted 28 December 2013; Published 15 May 2014

Academic Editor: Janaka Karalliedde

Copyright © 2014 Andrea M. Isidori et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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 (). Age-adjusted pulse pressure was positively correlated with ED severity and negatively with androgens and waist circumference (). A decline in total testosterone was observed with increasing arterial pulse pressure (), 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.