Six months of daily treatment with vardenafil improves parameters of endothelial inflammation and of hypogonadism in male patients with type 2 diabetes and erectile dysfunction: a randomized, double-blind, prospective trial. Issue 4 (April 2016)

• Record Type: Journal Article
• Authors: Santi, Daniele; Granata, Antonio R M; Guidi, Alessandro; Pignatti, Elisa; Trenti, Tommaso; Roli, Laura; Bozic, Roberto; Zaza, Stefano; Pacchioni, Chiara; Romano, Stefania; Nofer, Jerzy Roch; Rochira, Vincenzo; Carani, Cesare; Simoni, Manuela
• Is Part Of: European journal of endocrinology. Volume 174:Issue 4(2016)
• Page Start: 513
• Page End: 522
• Publication Date: 2016-04
• Subjects: Endocrinology -- Periodicals; 616.4005
• DOI: 10.1530/EJE-15-1100
• Languages: English
• ISSNs: 0804-4643

Abstract

Abstract : Objective: Type 2 diabetes mellitus (T2DM) is associated with endothelial dysfunction, characterized by a reduction of nitric oxide (NO)-mediated relaxation. Phosphodiesterase type 5 inhibitors (PDE5i) improve NO levels. The aim of the study was to investigate whether long-term, chronic treatment with the PDE5i vardenafil improves systemic endothelial function in diabetic men. Design: A prospective, investigator-initiated, randomized, placebo-controlled, double-blind, clinical trial was conducted. Methods: In total, 54 male patients affected by T2DM, diagnosed within the last 5 years, and erectile dysfunction were enrolled, regardless of testosterone levels. In all, 26 and 28 patients were assigned to verum and placebo groups respectively. The study consisted of an enrollment phase, a treatment phase (24 weeks) (vardenafil/placebo 10 mg twice in a day) and a follow-up phase (24 weeks). Parameters evaluated were as follows: International Index of Erectile Function 15 (IIEF-15), flow-mediated dilation (FMD), serum interleukin 6 (IL6), endothelin 1 (ET-1), gonadotropins and testosterone (measured by liquid chromatography/tandem mass spectrometry). Results: IIEF-15 erectile function improved during the treatment ( P <0.001). At the end of the treatment both FMD ( P =0.040) and IL6 ( P =0.019) significantly improved. FMD correlated with serum testosterone levels ( R 2 =0.299; P <0.001). Testosterone increased significantly under vardenafil treatment and returned in the eugonadal range only in hypogonadal men ( n =13), without changes in gonadotropins. Chronic vardenafil treatment did not result in relevant side effects. Conclusion: This is the first double-blind, placebo-controlled clinical trial designed to evaluate the effects of chronic treatment of vardenafil on endothelial health-related parameters and sexual hormones in patients affected by a chronic disease. Chronically administered vardenafil is effective and improves endothelial parameters in T2DM patient. Moreover, chronic vardenafil therapy improves hypogonadism in diabetic, hypogonadal men.