Re: 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

2016 ◽  
Vol 196 (2) ◽  
pp. 518-519
Author(s):  
Allen D. Seftel
2016 ◽  
Vol 174 (4) ◽  
pp. 513-522 ◽  
Author(s):  
Daniele Santi ◽  
Antonio R M Granata ◽  
Alessandro Guidi ◽  
Elisa Pignatti ◽  
Tommaso Trenti ◽  
...  

ObjectiveType 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.DesignA prospective, investigator-initiated, randomized, placebo-controlled, double-blind, clinical trial was conducted.MethodsIn 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).ResultsIIEF-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 (R2=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.ConclusionThis 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.


2021 ◽  
Vol 15 (3) ◽  
pp. 949-953
Author(s):  
Yehia M. Ghanem ◽  
Abdel Rahman M. Zahran ◽  
Doreen N. Younan ◽  
Mohammed H. Zeitoun ◽  
Amr Y. El Feky

2021 ◽  
Author(s):  
Min-Kyung Lee ◽  
Jae-Hyuk Lee ◽  
Seo-Young Sohn ◽  
Seo Yeon Lee ◽  
Tae-Yoong Jeong ◽  
...  

Abstract Background: Phosphodiesterase type 5 inhibitors restore nitric oxide signaling, which plays a significant role in erectile function and appears to counteract insulin resistance in animal and human models. This study was aimed to evaluate the glycemic and metabolic effects of low-dose tadalafil once a day in patients with type 2 diabetes and erectile dysfunction.Methods: A 6-month, randomized, double-blind, placebo-controlled pilot trial was conducted. Eligible patients were randomly assigned in a ratio of 2:1 to the tadalafil 5 mg and placebo groups; all patients received either tadalafil or placebo once a day. The primary efficacy endpoint was the change in the glycated hemoglobin (HbA1c) level during the 6-month study period. The secondary efficacy endpoints included metabolic parameters and erectile function. Results: Of the 68 patients who completed this study, 45 and 23 patients were allocated in the tadalafil and placebo groups, respectively. The mean HbA1c level was significantly different between the groups over the 6-month study period (P = 0.021). After 6 months of treatment, the HbA1c decrement in the tadalafil group was greater than that in the placebo group (-0.14% ± 0.53% vs. 0.20% ± 0.69%, P = 0.030). The improvement in the International Index of Erectile Function-5 scores were significantly greater in the tadalafil group than in the placebo group at 6 months (P = 0.003). Conclusion: This prospective pilot study shows that low-dose tadalafil once a day is effective in improving glycemic control and erectile function in patients with type 2 diabetes and erectile dysfunction.Trial Registration: KCT0005666


2018 ◽  
Vol 4 (2) ◽  
pp. 58-62
Author(s):  
Roksana Yeasmin ◽  
MA Muttalib ◽  
Kazi Nazneen Sultana ◽  
Nizamul Hoque Bhuiyan ◽  
Md Jamil Hasan Karami ◽  
...  

Background: Type 2 diabetes mellitus is a chronic disease characterized by relative or absolute deficiency of insulin, resulting in glucose intolerance.Objectives: The present study was planned to see the associations of serum uric acid with positive Rheumatoid factor in type 2 male diabetes mellitus patients. Methodology: This case control study was carried out at the department of Biochemistry at Ibrahim Medical College, Dhaka, Bangladesh. The duration of the study was from June 2015 to June 2016 for a period of one year. In this present study, male patients with type 2 diabetes mellitus were taken as case group and age and sex matched healthy male were taken as control group. Rheumatoid factor was measured from the blood of all case and control group respondents. Others blood para meters were also measured for the correlation with the diabetes mellitus patients.Results: In this present study, 110 male patients presented with type 2 diabetes mellitus were recruited as case and age and sex matched healthy male were recruited as control. More rheumatoid factor positive in type 2 DM male patients with the uric acid range between 6.5 to 9.5 mg/dL. The number of patients was 5 out of total 9 rheumatoid factor positive cases. In this study serum uric acid was significantly correlated with rheumatoid factor in type 2 male diabetic patients. Rheumatoid factor positive cases were taking insulin among 9 and it was statistically significantly associated (p<0.001). Conclusion: In this study serum uric acid is significantly associated with positive rheumatoid factor in type 2 male diabetic patients.Journal of Current and Advance Medical Research 2017;4(2):58-62


2017 ◽  
Author(s):  
Agathi Vasileiou ◽  
Ioanna Karathanassi ◽  
Parthena Navrozidou ◽  
Marianna Vlychou ◽  
Georgios Koukoulis ◽  
...  

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