The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction—STED TRIAL)

Abstract

The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction (ED) secondary to endothelial dysfunction. This study is a double-blind, randomized, placebo-controlled, clinical trial in patients with ED and endothelial dysfunction. Patients were randomized to receive 20 mg simvastatin (n ¼ 21) or placebo (n ¼ 20) daily for 6 months and subsequently 10 mg of vardenafil on demand for 4 weeks. Serum cholesterol, hormone profile, ultrasensitive C-reactive protein, the International Index of Erectile Dysfunction (IIEF) and the ED Index of Treatment Satisfaction were evaluated. There was a significant reduction in serum cholesterol in the treatment group. The hormonal profile remained unaltered. There was no difference in the IIEF between the groups at follow-up, although, at the beginning, 26% of the patients of both groups presented with mild ED and 74% with moderate-to-severe ED; at the end of the 7th month, all patients from the simvastatin group progressed to mild ED, compared with only 83% in the placebo group. There was no statistically significant difference in penile erection after intake of simvastatin or placebo. This study does not support the use of simvastatin as erectogenic medication. Further studies are necessary to verify if simvastatin has any beneficial effect on ED.

The role of statins in erectile dysfunction: a systematic review and meta-analysis

“…The primary findings of five studies was an improvement of erectile function after statins administration,1718192021 whereas, the other two studies had no significant difference between the statins and the control groups 2223. The methods used to assess erectile function was IIEF-5 in five trials,1718192223 and ED domain score in two trials 2021. The ED domain score could not be integrated in the meta-analysis because one study did not provide the standard deviation 20.…”

“…The ED domain score could not be integrated in the meta-analysis because one study did not provide the standard deviation 20. Hence, only the five studies applying IIEF-5 scores to evaluate erectile function were included in the meta-analysis 1718192223. We did not perform a test for funnel plot asymmetry because only five studies were included in the meta-analysis 1718192223.…”

“…With 629 articles identified, seven studies were retrieved that were RCTs17181920212223 ( Figure 1 ). The International Index of Erectile Function (IIEF) is a validated and widely used multidimensional, self-report instrument for the evaluation of male sexual function 24.…”

The Association Between Dyslipidemia and Its Treatment with Erectile Dysfunction

“…In contrast to the aforementioned studies, a double-blind, randomized, placebocontrolled, clinical trial in patients with ED and endothelial dysfunction reported no signifi cant difference in penile erection between those treated with simvastatin and the placebo group [ 39 ].…”

Erectile dysfunction – overview from a cardiovascular perspective

“…Overall, statin therapy alone [39], as well as in combination with PDE-5 inhibitor therapy, was shown to improve the sexual health related quality of life in ED patients but may not be considered an erectogenic drug [40]. Nevertheless, it is suspected that statin therapy may improve the effi cacy of PDE-5 inhibitor therapy in patients with endothelial dysfunction [40].…”