Introduction Erectile dysfunction (ED) affects up to 70% of men with diabetes, occurring with a higher prevalence in those with type 1 diabetes than with type 2 diabetes. Studies investigating treatment of ED in men with diabetes have largely been conducted in a total male population with diabetes. Limited data are available on the efficacy and safety of the potent oral phosphodiesterase-5 inhibitor vardenafil in men with ED and type 1 diabetes. Aims To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED. Methods In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-naïve patients were randomized to receive placebo (N = 149) or flexible-dose (5–20 mg) (N = 153) vardenafil. Main Outcome Measure Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively. Results Vardenafil significantly improved mean success rates for Sexual Encounter Profile 2 and 3 compared with baseline and placebo at 4, 8, and 12 weeks (P < 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA1c (HbA1c < 7%, good glycemic control; HbA1c >7–≤8%, moderate glycemic control; and HbA1c > 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P < 0.0001) of the International Index of Erectile Function compared with placebo, in addition to scores for the other individual domains of the International Index of Erectile Function. The most commonly reported treatment-emergent adverse events were headache (3.1%) and flushing (2.5%), which were mild to moderate and transient in nature. Conclusion These data suggest that vardenafil significantly improves erectile function in men with type 1 diabetes and is well tolerated, regardless of the level of glycemic control.

Introduction The prevalence of erectile dysfunction (ED) is increased in men with metabolic syndrome compared with the general population. Aim The aim of this study was to evaluate the efficacy and safety of vardenafil vs. placebo in men who had ED and metabolic syndrome. Methods This was a 12-week, double-blind, randomized, multicenter, parallel-group, placebo-controlled prospective study in men with ED and metabolic syndrome (assessed by the International Diabetes Federation criteria). Vardenafil was administered at a starting dose of 10 mg, which could be titrated to 5 mg or 20 mg after 4 weeks, depending on efficacy and tolerability. Main Outcome Measures Primary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile (SEP) diary questions 2/3. Secondary efficacy measures included SEP1, a diary question assessing ejaculation, the percentage of men achieving “return-to-normal” erectile function, and the percentage of men who titrated to a different dose. Adverse events (AEs) were recorded throughout the study. Results The intent-to-treat population included 145 men (vardenafil, N = 75; placebo, N = 70). Baseline least squares IIEF-EF domain scores were low (vardenafil: 12.0; placebo: 12.7), indicative of moderate-to-severe ED. Vardenafil was statistically significantly superior to placebo for all primary efficacy measures (P < 0.0001) and showed nominally statistically significant superiority compared with placebo for SEP1/ejaculation success rates (P = 0.0003 and P < 0.0001, respectively) and the percentage of subjects reporting “return-to-normal” erectile function (P = 0.0004). Treatment-emergent AEs were mild-to-moderate in severity and consistent with the known AE profile of phosphodiesterase type 5 inhibitors. Conclusions This is the first study to assess the efficacy and safety of vardenafil, taken alone, for ED therapy in a population of men who all had metabolic syndrome. Although baseline erectile function in these patients was low, vardenafil treatment was associated with significant improvements in erectile function and rates of successful intercourse, and was well tolerated.

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Sexualstörungen werden bei Menschen mit Diabetes nicht ausreichend beachtet und ernst genommen. Es wird auch unter Diabetologen häufig die Meinung vertreten, dass andere Probleme in der Versorgung von Diabetespatienten vorrangig sind. Sexualstörungen werden immer noch häufig als Befindlichkeitsstörung abgetan. Obwohl gerade der Erhalt einer hohen Lebensqualität bei der Betreuung von Diabetespatienten ständig betont wird, unterschätzt man die Auswirkungen von Sexualstörungen bei diabetischen Frauen und Männern auf deren psychische und somatische Gesundheit.Sexualstörungen stellen eine eindeutige Einschränkung der Lebensqualität dar. Wenn ein Leidensdruck vorhanden ist und ein Therapiewunsch besteht, sollte deswegen eine Behandlung wie bei anderen Folgeschäden angeboten werden. Diabetespatienten sind häufiger und in einem früheren Lebensalter von Sexualstörungen betroffen als die nichtdiabetische Bevölkerung. Die Sexualstörungen der diabetischen Frau umfassen Libido-, Erregungs-, Orgasmus-und Befriedigungsstörungen. Bei den Sexualstörungen des diabetischen Mannes werden im Wesentlichen Libido-, Orgasmus-, Ejakulations-und Erektionsstörungen genannt.Die Effektivität und Akzeptanz der Therapiemodalitäten der einzelnen Sexualstörungen werden unterschiedlich bewertet. Unbestritten ist, dass bei der erektilen Dysfunktion des diabetischen Mannes insbesondere Phosphodiesterase-5-Inhibitoren erfolgreich eingesetzt werden können. AbstractSexual dysfunction is widely neglected in diabetology. Diabetologists are often of the opinion that treating other problems in the diabetic patient should take priority. Sexual dysfunction is considered as only a disorder rather than as a disease. Although the main goal of treating diabetic patients today is achieving a high quality of life, the psychological and somatic effects of sexual dysfunction in diabetic men and women is underestimated.Sexual dysfunction represents a significant impairment on quality of life. When this is the case and a patient wishes treatment, this should be available in the same way as other treatments for diabetic complications. Sexual dysfunction is found in diabetic patients more often and at a younger age than in the non-diabetic population. Sexual dysfunction in diabetic women comprises disorders of sexual desire, arousal, orgasm and satisfaction. Sexual dysfunction in diabetic men comprises disorders of sexual desire, orgasm, ejaculation and erection.Although effectiveness and acceptance of treatment regimes for these sexual dysfunctions are rated differently, there is no doubt that treatment for erectile dysfunction in diabetic men is very effective using PDE-5 inhibitors.

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