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.

Figure 1

Study design (STARD plot).

Figure 2

Prevalence of CV risk (CVR) classes and number of metabolic syndrome (MS) criteria in the study population.

Figure 3

Distribution of CV risk in the general population and in the ED population.

Figure 4

Pulse pressure and serum testosterone stratified according to cardiovascular risk.

Figure 5

Distribution of testosterone and LH levels stratified according to quartiles of pulse pressure. Open boxes are total testosterone values (left vertical axis) and solid gray boxes are LH values (right vertical axis).

Figure 6

Response to vardenafil measured by the international index of erectile function (IIEF-5).

Figure 7

Change in IIEF-5 score in the population stratified according to quartiles of pulse pressure.

Figure 8

Comparisons of efficacy and safety for vardenafil treatment in subject with low versus high cardiovascular risks.