Department of Experimental Medicine-Medical Pathophysiology, Food Science and Endocrinology Section, University “Sapienza”, Rome, Italy.
Int J Cardiol. 2012 Oct 18;160(3):187-91. doi: 10.1016/j.ijcard.2011.04.003. Epub 2011 May 5.
It is known that the incidence of endothelial dysfunction in patients with vascular erectile dysfunction (ED) is increased. The effects of daily vardenafil on endothelial function and arterial stiffness in patients with erectile dysfunction (ED) have never been investigated.
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 10mg daily or 20mg 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).
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.
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.
已知血管性勃起功能障碍（ED）患者内皮功能障碍的发生率增加。每日伐地那非对勃起功能障碍（ED）患者的内皮功能和动脉僵硬度的影响尚未被研究过。
20 名患有血管性 ED 的男性（平均 IIEF5=12±6，峰值收缩速度-PSV=24±2cm/s）参加了一项为期 4 周、随机、双盲、双模拟、交叉研究（平均年龄 59±11），并接受了每日 10mg 伐地那非或按需 20mg 伐地那非治疗，两种治疗方案之间有两周洗脱期。主要终点是指尖外周动脉张力计（PAT）设备评估的反应性充血（RH）和增强指数（AI）的基线变化。次要终点是 IIEF-5 和 SEP3 评分从基线的变化和内皮功能的血浆替代标志物，即内皮素-1（ET-1）和肾上腺髓质素（ADM）。
与按需治疗相比，每日服用伐地那非的患者（vs. 按需）动脉僵硬度评估的 AI 显著改善（P<0.01），且血浆 ADM 水平降低（p<0.05），但平均 RH 无改善。当校正心率后，ADM 与 AI 呈强直接关系（r(2)=0.22；p<0.005）。IIEF5 评分≥22 的患者比例或 SEP3 成功率无差异。与基线相比，两种治疗方法均显著提高了 IIEF5 评分（p<0.001）和 SEP3 反应率（p<0.0001）。
我们证明了每日伐地那非可改善严重血管性 ED 男性的动脉僵硬度和勃起功能测量。这种效果可能至少部分是通过降低 ADM 循环水平来介导的。
