Efficacy and Safety of Flexible-Dose Vardenafil in Men with Type 1 Diabetes and Erectile Dysfunction

Abstract

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.

Ca2+‐activated K+ channel (KCa) stimulation improves relaxant capacity of PDE5 inhibitors in human penile arteries and recovers the reduced efficacy of PDE5 inhibition in diabetic erectile dysfunction

“…In fact, reduced response rates to therapy with PDE5 inhibitors have been observed in populations of either type 1 (Boulton et al, 2001;Ziegler et al, 2006) or type 2 (Stuckey et al, 2003) diabetic men. Positive effects here obtained with KCa activators in tissues from type 2 diabetic patients as well as in vivo in an animal model of type 1 diabetes suggest that results could be generalizable to both types of diabetes.…”

ACceptance of Therapy In Vardenafil-treated patients with Erectile dysfunction (ACTIVE): a noninterventional study in Germany

“…This is consistent with the findings from clinical trials of men with ED and diabetes, hypertension and dyslipidemia, and from noninterventional studies. [13][14][15][16][17][18][19]21 Conditions such as diabetes and severe vascular disease can adversely affect the treatment outcomes in ED, 22 but the beneficial outcome with PDE5 inhibitors is likely to be unaffected, except in patients with advanced vascular impairment. A further consideration is the possibility of adverse drug interactions, as long-term medication is usual among patients with underlying conditions.…”

“…Previously, vardenafil was shown to be efficacious and well tolerated in clinical trials of patients with diabetes, 13,14 hypertension 15,16 and dyslipidemia, 17 as well as in the Real-Life Safety and Efficacy of vardenafil (REALISE) study, a worldwide noninterventional study that included large numbers of men with ED and cardiovascular and metabolic conditions. 18,19 This paper presents the data collected in Germany between July 2005 and January 2007.…”

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

“…The severity of ischemic heart disease correlates with the severity of ED [5], and there is evidence of a higher prevalence and severity of ED in patients with hypertension and diabetes [2]. In addition, patients with comorbid diabetes exhibit an impaired response to ED pharmacotherapy compared with those without diabetes [6][7][8].…”