Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double‐blind, 12‐week, flexible‐dose, placebo‐controlled erectile dysfunction clinical trial

Abstract

Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA OBJECTIVE To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS A multicentre, double‐blind, 12‐week, flexible‐dose, placebo‐controlled trial was conducted, involving 463 men aged ≥ 18 years with moderate‐to‐severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4‐week treatment‐free run‐in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS There was significantly better EF with vardenafil than with placebo throughout the study. The least‐square mean EF domain scores increased from 9.3 at baseline to 17.6 at the ‘last’ observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least‐square mean per‐patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score ≥ 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase‐5 inhibitor profile. CONCLUSION Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).

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“…Therefore, compared with the placebo groups, the IIEF score for patients who received PDE-5 inhibitors increased by ≥ 9 points. At present, an increase of 5 points is 16 Therefore, the data suggest that PDE-5 inhibitors are an effective treatment for ED after kidney transplant. The Global Efficacy Questionnaire showed that 66% of renal transplant recipients believed that treatment had improved their erections (patients who were not transplant recipients, 73%).…”

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

“…The study enrolled 463 men with ED unresponsive to sildenafil (no response in at least four of six attempts with sildenafil) to vardenafil 10 mg (that could be titrated to 5 or 20 mg) or placebo. 127 Compared to placebo, the percentage of penetrations (30 vs 62%) and successful intercourse (11 vs 46%) was higher with vardenafil. 127 Also, this study shown that vardenafil was more effective than placebo from after 0.25 h until beyond 6 h. 128 In order to replace sildenafil in the treatment of ED, vardenafil will have to be shown to be superior to sildenafil.…”

“…127 Compared to placebo, the percentage of penetrations (30 vs 62%) and successful intercourse (11 vs 46%) was higher with vardenafil. 127 Also, this study shown that vardenafil was more effective than placebo from after 0.25 h until beyond 6 h. 128 In order to replace sildenafil in the treatment of ED, vardenafil will have to be shown to be superior to sildenafil. To date, there are no obvious major differences between sildenafil and vardenafil.…”

Daily use of phosphodiesterase 5 inhibitors for erectile dysfunction and lower urinary tract symptoms

“…Changing the type of PDE5 inhibitors for nonresponders has typically had less drastic results. 30 Another difficult-to-treat group are patients with comorbidities such as coronary artery disease and diabetes. Mirone et al 31 compared two different dosing regimens in 4262 subjects.…”