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In this article, authors discuss the study "Cardiovascular Outcomes Among Sildenafil Users: Results of the International Men's Health Study," that was published in the "International Journal of Clinical Practice" in 2008. Topics discussed include approval of sildenafil for the treatment of erectile dysfunction (ED) in the U.S., the planning of the International Men's Health Study (IMHS) on sexual dysfunction and risks associated with phosphodiesterase type 5 inhibitor (PDE5).

Sildenafil treatment has not been evaluated in a double-blind, placebo-controlled (DBPC) trial specific to men with mild erectile dysfunction (ED), defined by a 22-25 score on the International Index of Erectile Function-erectile function domain (IIEF-EF). To assess sildenafil efficacy in sexually dissatisfied men with mild ED. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), IIEF, Quality of Erection Questionnaire (QEQ), Erection Hardness Score (EHS 4 = completely hard/fully rigid), general efficacy questions (GEQs), event log questions (hardness sufficient for penetration, duration sufficient for successful intercourse, ejaculation/orgasm, and second erection within 24 hours), and analog scales (erection firmness, reliability, and maintenance, and general sexual performance). Eight-week DBPC flexible-dose (25, 50, or 100 mg) trial with 6-week, open-label (OL) extension. One hundred and seventy-six men were randomized (mean ± standard deviation: age, 50 ± 12 year; ED duration, 3.5 ± 3.2 year). Most had organic or mixed ED. For sildenafil vs. placebo, 66% vs. 89% titrated to 100 mg and efficacy at DBPC end was better, including the EDITS Index score (least squares mean [standard error], 80.3 [2.3] vs. 62.1 [2.5]; P < 0.0001); treatment satisfaction (EDITS Index score >50 in 89% vs. 63%; P = 0.0001); no ED (IIEF-EF ≥26 in 58% vs. 39%; P < 0.05); GEQs (≥4.9-fold greater odds of improved erections and ability to have sexual intercourse); and EHS 4 (47.2% vs. 25.2% of occasions; P < 0.0001). At OL end, 93% of men were satisfied (EDITS Index score > 50), 77% had no ED, and ≥89% were GEQ responders; mean scores on IIEF domains, the QEQ, and analog scales were >80% of the maximum; 60% of occasions had EHS 4; and event log responses were positive on >80% of occasions, except for second erections (41.9%). Headache, nasal congestion, and flushing, mostly mild to moderate, were the most common adverse events. Men with mild ED derive substantial benefit from sildenafil treatment. [ABSTRACT FROM AUTHOR]

Introduction. The importance of patient instructions, designed to optimize therapy with phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction (ED), has recently been demonstrated. Aim. To evaluate the impact of an educational program for new sildenafil users against usual ED management in Canadian primary care practices. Methods. This multicenter, 6-month cluster randomized prospective study was conducted across Canada in general practitioners' offices where sites were randomized to receive a treatment optimization program (TOP) tool at visit 1 (TOP sites) or not to receive the TOP tool (non-TOP sites) while continuing with usual practice. Study participants were men seeking medical attention for ED and who were sildenafil naïve. The TOP tool consisted of a tear-off sheet, a brochure, and a video. Study drug was not provided to the patients. Sildenafil samples and prescriptions were dispensed as per usual care practices. Main Outcome Measures. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to determine treatment satisfaction at visit 2 (month 3) and visit 3 (month 6). Patient and physician satisfaction with the TOP tool was assessed using self-reported questionnaires. Results. The intent-to-treat (ITT) population consisted of 2,573 patients from 231 primary care sites. At visits 2 and 3, treatment satisfaction with sildenafil was high with almost 9 patients out of 10 satisfied with treatment. No significant statistical differences were observed in the EDITS scores between the TOP and the non-TOP groups at visits 2 and 3. More than 80% of the participants were satisfied or very satisfied with the video and the brochure. More than 8 out of 10 participating physicians (84%) would use the TOP tool in their current practice if available. Conclusions. TOP is a valuable and time-efficient ED management tool providing benefits to newly diagnosed ED patients and to their physicians. Brock G, Carrier S, Casey R, Tarride J-E, Elliott S, Dugré H, Rousseau C, D'Angelo P, and Defoy I. Can an educational program optimize PDE5i Therapy? A study of Canadian primary care practices. J Sex Med 2007;4:1404–1413. [ABSTRACT FROM AUTHOR]

Introduction. While the efficacy of sildenafil for the management of erectile dysfunction (ED) has been demonstrated in randomized clinical trials, few data exist on its effectiveness in a real-life setting. Aim. The objective of this study was to examine the treatment satisfaction and effectiveness with sildenafil in a real-life setting in Canada. Methods. A multicenter, prospective study, using an educational program aimed at optimizing sildenafil treatment, was conducted at 231 primary care sites across Canada. Patients who received their first prescription of sildenafil for ED within the usual practice of medicine were invited to participate in the study. Data were collected through patient self-administered questionnaires. Main Outcome Measures. The Sexual Health Inventory for Men (SHIM) questionnaire was used to determine the erectile function at baseline, month 3 and month 6. Treatment satisfaction at months 3 and 6 was assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Results. The intent-to-treat population consisted of 2,573 patients. The mean age was 55 years (18 to 92 years). At baseline, the mean SHIM score was 11.9 with 21.7% of men having severe ED, 22.9% moderate ED, 36.5% mild-to-moderate ED, and 16.9% mild ED. At month 3, the mean SHIM score improved significantly to 18.0 ( P < 0.0001) and 33.3% of patients had a SHIM score above 21 (no ED). At 6 months, the mean SHIM score was 18.7. At both months 3 and 6, approximately 89% of patients were satisfied with their treatment (i.e., EDITS score ≥ 50), suggesting no attenuation of the satisfaction over the 6 months of use. Conclusions. The effectiveness of sildenafil in the management of ED was demonstrated in a large cohort of men treated in a primary care setting in this Canadian real-life study. Persistence with therapy and lack of attenuation over time among the vast majority of men was shown. Carrier S, Brock G, Casey R, Tarride J-E, Elliott S, Dugré H, Rousseau C, D’Angelo P, and Defoy I. Treatment satisfaction with sildenafil in a Canadian real-life setting. A 6-month prospective observational study of primary care practices. J Sex Med 2007;4:1414–1421. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Associate EditorMichael G. WyllieEditorial BoardIan Eardley, UKJean Fourcroy, USASidney Glina, BrazilJulia Heiman, USAChris McMahon, AustraliaBob Millar, UKAlvaro Morales, CanadaMichael Perelman, USATo evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil.A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged≥ 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).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≥ 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.Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history). [ABSTRACT FROM AUTHOR]