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).

UNLABELLED: 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.

Magnetic resonance imaging assessment of squamous cell carcinoma of the anal canal before and after chemoradiation: can MRI predict for eventual clinical outcome?

PURPOSE: To describe the MRI appearances of squamous cell carcinoma of the anal canal before and after chemoradiation and to assess whether MRI features predict for clinical outcome. METHODS AND MATERIALS: Thirty-five patients (15 male, 20 female; mean age 60.8 years) with histologically proven squamous cell cancer of the anal canal underwent MRI before and 6-8 weeks after definitive chemoradiation. Images were reviewed retrospectively by two radiologists in consensus blinded to clinical outcome: tumor size, signal intensity, extent, and TNM stage were recorded. Following treatment, patients were defined as responders by T and N downstaging and Response Evaluation Criteria in Solid Tumors (RECIST). Final clinical outcome was determined by imaging and case note review: patients were divided into (1) disease-free and (2) with relapse and compared using appropriate univariate methods to identify imaging predictors; statistical significance was at 5%. RESULTS: The majority of tumors were ≤T2 (23/35; 65.7%) and N0 (21/35; 60%), mean size 3.75 cm, and hyperintense (++ to +++, 24/35 patients; 68%). Following chemoradiation, there was a size reduction in all cases (mean 73.3%) and a reduction in signal intensity in 26/35 patients (74.2%). The majority of patients were classified as responders (26/35 (74.2%) patients by T and N downstaging; and 30/35 (85.7%) patients by RECIST). At a median follow-up of 33.5 months, 25 patients (71.4%) remained disease-free; 10 patients (28.6%) had locoregional or metastatic disease. Univariate analysis showed that no individual MRI features were predictive of eventual outcome. CONCLUSION: Early assessment of response by MRI at 6-8 weeks is unhelpful in predicting future clinical outcome.