ORIGINAL RESEARCH—ED PHARMACOTHERAPY: Comparing Vardenafil and Sildenafil in the Treatment of Men with Erectile Dysfunction and Risk Factors for Cardiovascular Disease: A Randomized, Double‐Blind, Pooled Crossover Study

摘要: ABSTRACT Introduction Data from head‐to‐head clinical trials of phosphodiesterase type 5 (PDE5) inhibitors are scarce, making it difficult for clinicians to differentiate among these agents select the most appropriate treatment their patients with erectile dysfunction (ED). Aim This randomized, double‐blind, crossover trial compared patient preference, efficacy, and safety vardenafil sildenafil in men ED diabetes, hypertension, and/or hyperlipidemia. Methods Prospective analysis was performed on two studies which 1,057 were randomized 20 mg (N = 530) or 100 mg (2 × 50 mg encapsulated tablets) (N = 527) 4 weeks. Following a 1‐week washout, switched Main Outcome Measures Patients asked about overall preference: “Overall, medication do you prefer?”, plus 11 other preference questions relating treatment. Efficacy assessments after each period included function (EF) domain score International Index Erectile Function (IIEF); Sexual Encounter Profile (SEP) diary SEP2 SEP3; Global Assessment Question (GAQ); Treatment Satisfaction Scale (TSS). regarding adverse events collected throughout study. Results A total 931 (mean age 57.9 years) intent‐to‐treat (ITT) population. Non‐inferiority over achieved (vardenafil 38.9%; 34.5%; no 26.6%). Additionally, change baseline EF IIEF nominal significance (10.00 vs. 9.40; P  = 0.0052). also had higher percentage positive responses SEP2, SEP3, GAQ, 12 19 TSS. Both drugs well tolerated. Conclusions cardiovascular risk factors demonstrated noninferiority preference. Vardenafil statistical superiority several frequently used efficacy measures. Rubio‐Aurioles E, Porst H, Eardley I, Goldstein I Vardenafil–Sildenafil Comparator Study Group. Comparing disease: pooled J Sex Med 2006;3:1037–1049.