Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction in Elderly Men and Those with Underlying Conditions: An Integrated Analysis of Two Pivotal Trials

Men with erectile dysfunction (ED) are typically older and have one or more underlying cardiovascular conditions. To determine the efficacy and safety of a new orodispersible tablet (ODT) formulation of vardenafil for the treatment of ED, and whether age, or the presence of underlying conditions affects treatment outcomes. This is an integrated analysis of data from two phase III, double‐blind, multicenter, randomized, parallel‐group, placebo‐controlled studies that compared 10 mg on‐demand vardenafil ODT with placebo in a general population of men with ED, stratified so that approximately 50% of patients were aged ≥65 years. Results were reported by age (