Can simvastatin improve erectile function and health‐related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971]1

• Published in: BJU international Vol. 108; no. 11; pp. 1850 - 1854
• Main Authors: Trivedi, Daksha, Kirby, Michael, Norman, Felicity, Przybytniak, Izabela, Ali, Shehzad, Wellsted, David M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.12.2011; Wiley Subscription Services, Inc
• Subjects: Aging; cardiovascular risk; erectile dysfunction; health related quality of life; Men; Quality of life; Sexual disorders; simvastatin; Statins
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1111/j.1464-410X.2011.10122.x

What’s known on the subject? and What will the study add? Erectile dysfunction is often associated with endothelial dysfunction. It is also recognized as a marker for underlying vascular disease. This study tests the hypothesis that statin therapy may improve erectile function and also reduce the risk of future cardiovascular events via a reduction in serum cholesterol and by improving endothelial function. The study will also determine whether the treatment improves quality of life related to sexual function. OBJECTIVE • To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health‐related quality of life in men aged ≥40 years with erectile dysfunction. PATIENTS AND METHODS • The study is a randomized, double‐blind, placebo‐controlled trial to test the hypotheses that statins improve endothelial function and reduce cholesterol and may improve erectile function in men with untreated erectile dysfunction (ED). • Study subjects are men ≥40 years who are not receiving lipid‐lowering or anti‐hypertensive medication and have no other cardiovascular disease (CVD) risk factors. • Eligible men with untreated ED are randomized to double‐blind treatment with 40 mg simvastatin or placebo once daily for 6 months. • Data are collected at baseline, mid‐trial and at the final follow‐up visit at 30 weeks. • The main outcome is erectile function measured by the five‐item version of the International Index of Erectile Function. Secondary outcomes include sexual‐health‐related quality of life and endothelial function. RESULTS • Ten general practices have been recruited in the east of England. • We have randomized 173 men for a power of 90% to assess the main outcome. • To date there have been no serious unexpected adverse events. • Study findings will be available in September 2011. CONCLUSION • If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD.