Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction

J Sex Med. 2006 Sep;3(5):883-891. doi: 10.1111/j.1743-6109.2006.00295.x.

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 HbA(1c) (HbA(1c) < 7%, good glycemic control; HbA(1c) >7- < or = 8%, moderate glycemic control; and HbA(1c) > 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Diabetes Mellitus, Type 1 / complications*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Erectile Dysfunction / drug therapy*
  • Erectile Dysfunction / etiology
  • Humans
  • Imidazoles / administration & dosage*
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Phosphodiesterase Inhibitors / administration & dosage*
  • Piperazines / administration & dosage*
  • Quality of Life
  • Sexual Behavior / drug effects*
  • Sulfones / administration & dosage
  • Surveys and Questionnaires
  • Treatment Outcome
  • Triazines / administration & dosage
  • Vardenafil Dihydrochloride

Substances

  • Imidazoles
  • Phosphodiesterase Inhibitors
  • Piperazines
  • Sulfones
  • Triazines
  • Vardenafil Dihydrochloride