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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/m² 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., (© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.)

Objective: To assess patient and partner preferences for, and satisfaction with, tadalafil or sildenafil (phosphodiesterase type 5 inhibitors) in routine clinical practice for treating erectile dysfunction (ED), as these are important outcomes that might influence treatment adherence., Patients and Methods: In a multicentre, prospective observational trial in Canada, patients with ED were eligible if they planned to change treatment from tadalafil to sildenafil or vice versa. Data were collected at baseline and 4-12 weeks later (endpoint). Satisfaction was assessed using patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS index scores range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction)., Results: Of 2425 patients, approximately 98% completed the study and 295 partners participated. When patients changed from sildenafil to tadalafil (1722 men) the mean EDITS index scores increased significantly for both patients (from 61.6 to 78.3) and partners (from 65.0 to 82.6; both P < 0.001). When patients changed from tadalafil to sildenafil (703 men), the mean EDITS index scores increased slightly but significantly for patients (from 68.8 to 70.2; P = 0.007) but not partners (from 76.8 to 68.9; P = 0.066). For the individual EDITS questions, mean scores increased significantly from baseline to endpoint on all questions for patients (all 11 questions; P < 0.001) and partners (all five questions; P < 0.001) in the sildenafil-to-tadalafil group, and in the tadalafil-to-sildenafil group, mean scores for patients decreased on nine of 11 questions (seven of nine significantly; P < 0.041) and mean scores for partners decreased on all five (two significantly; P < 0.049). For treatment preference, regardless of the change in treatment (i.e. sildenafil-tadalafil or tadalafil-sildenafil), a significantly higher percentage of patients and partners preferred tadalafil to sildenafil., Conclusions: These data indicate that patients with ED (and their partners) who changed from sildenafil to tadalafil treatment or vice versa in a routine clinical practice setting had higher treatment satisfaction when taking tadalafil than sildenafil, as assessed by most measures of EDITS. The higher treatment satisfaction with tadalafil might help to explain the greater preference for tadalafil compared with sildenafil in both patients and partners in this observational study.

Objective: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil., Patients and Methods: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ)., Results: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile., Conclusion: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).