A spontaneous, double-blind, double-dummy cross-over study on the effects of daily vardenafil on arterial stiffness in patients with vasculogenic erectile dysfunction

作者：Aversa Antonio^*; Letizia Claudio; Francomano Davide; Bruzziches Roberto; Natali Marco; Lenzi Andrea

来源：International Journal of Cardiology, 2012, 160(3): 187-191.

DOI：10.1016/j.ijcard.2011.04.003

• Peripheral arterial tonometry
• Reactive hyperemia
• Endothelial function
• Adrenomedullin
• Endothelin-1

Background: It is known that the incidence of endothelial dysfunction in patients with vascular erectile dysED) is increased. The effects of daily vardenafil on endothelial function and arterial stiffness in patients with erectile dysED) have never been investigated.
Methods: 20 men complaining vascular ED (mean IIEF5 = 12 +/- 6 and peak systolic velocity-PSV = 24 +/- 2 cm/s) were enrolled in a 4-week, randomized, double-blind, double-dummy, crossover study (mean age 59 +/- 11) and received either vardenafil 10 mg daily or 20 mg on-demand with a two-week washout interval. Primary endpoints were variation from baseline of reactive hyperemia (RH) and augmentation index (AI) calculated by fingertip peripheral arterial tonometry (PAT) device. Secondary endpoints were variations of IIEF-5 and SEP3 scores from baseline and plasma surrogate markers of endothelial function, i.e. endothelin-1 (ET-1) and adrenomedullin (ADM).
Results: Patients who took daily vardenafil (vs. on-demand) reported significant (P<0.01) improvements in arterial stiffness as evaluated by AI and reduction of plasma ADM levels (p<0.05) but no improvement in average RH. When corrected for heart rate, ADM showed a strong direct relationship with AI (r(2)=0.22; p<0.005). The proportion of patients with an IIEF5 score of >= 22 or in SEP3 percentage of success rates were similar. Each treatment resulted in significantly greater IIEF5 scores (p<0.001) and better SEP3 response rates (p<0.0001) compared with baseline.
Conclusions: We demonstrated that daily vardenafil improves arterial stiffness and erectile function measurements in men with severe vasculogenic ED. This effect may be mediated, at least in part, by a reduction in ADM circulating levels.

• 出版日期2012-10-18