Do men with mild erectile dysfunction have the same risk factors as the general erectile dysfunction clinical trial population?

Study Type – Symptom prevalence (prospective cohort/RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Erectile dysfunction (ED) that is mild (score of 22–25 on the Erectile Function domain of the International Index of Erectile Function) is often overlooked in clinical practice because men do not seek treatment or because healthcare professionals consider complaints of mild ED to be irrelevant and fail to evaluate such patients. ED is associated with increased prevalence of diseases that accompany ageing, including cardiovascular disease and diabetes, but there do not appear to be any published epidemiological data on the prevalence or risk for such diseases in populations of men with mild ED. Greater understanding of this population’s underlying risk for diseases associated with ED may highlight the importance of earlier diagnosis and treatment. In this study, the underlying risk for diseases associated with ED is compared between the first large population of men with mild ED for whom demographic and baseline data have been reported and a manufacturer’s database of men (representing the general ED clinical trial population), which is the largest population of men with ED for whom demographic and baseline data have been reported. The findings show that men with mild ED may have substantial underlying risk for diseases associated with ED, including hypertension, diabetes, and lipid disorders. OBJECTIVE • To compare the underlying risk for diseases associated with erectile dysfunction (ED; i.e. cardiovascular disease and diabetes) in a population of men with mild ED relative to a general ED clinical trial population. PATIENTS AND METHODS • Men enrolled in a randomized, double‐blind placebo‐controlled (DBPC) trial of sildenafil for the treatment of mild ED were compared with a database of men enrolled in 67 of the manufacturer’s other DBPC sildenafil trials. • The main outcome measures were baseline demographics, comorbidities and concomitant medications. RESULTS • In both populations, most men were white, approximately one quarter were smokers, and most had an organic component to their ED etiology. • In the mild ED population ( N = 176) versus the database population ( N = 14 537), mean ± sd (range) age was 50 ± 12 (19–84) versus 55 ± 11 (18–89) years, body mass index was 29 ± 5 (20–48) versus 28 ± 5 (11–64) kg/m 2 and ED duration was 3.5 ± 3.2 (<1–18) versus 4.6 ± 4.7 (<1–45) years. • The prevalence of comorbidities associated with ED was similar (hypertension 26.1% ( n = 46) vs 32.8%; diabetes mellitus 13.6% ( n = 24) vs 22.1%; dyslipidemias 12.5% ( n = 22) vs 11.7%; hypercholesterolemia 12.5% ( n = 22) vs 9.5%; gastro‐esophageal reflux disease 10.8% ( n = 19) vs 6.0%; benign prostatic hyperplasia 9.7% ( n = 17) vs 9.9%; depression 6.3% ( n = 11) vs 5.6%; and anxiety 4.0% ( n = 7) vs 1.6%), as was the rate of use of medications for those comorbidities. CONCLUSIONS • Men with mild ED have similar risk factors to a general ED clinical trial population. Thus, mild ED is an important indicator of risk for underlying disease associated with ED. • Inquiry into ED should be part of routine clinical evaluation to facilitate rapid identification and early intervention. • Men complaining of mild ED should be evaluated adequately for underlying cardiovascular risk.