Efficacy and Safety of Vardenafil for the Treatment of Erectile Dysfunction in Men with Metabolic Syndrome: Results of a Randomized, Placebo-Controlled Trial
| Autor: | Frank Merfort, Manfred Beneke, Ernst Ulbrich, Monika Hermanns, Tim Schneider, Jochen Gleißner |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty Urology Endocrinology Diabetes and Metabolism Population Placebo-controlled study Placebo Piperazines law.invention Endocrinology Erectile Dysfunction Vardenafil Dihydrochloride Randomized controlled trial law Internal medicine Humans Medicine Sulfones Prospective cohort study education Aged Metabolic Syndrome education.field_of_study Triazines business.industry Imidazoles Middle Aged Phosphodiesterase 5 Inhibitors medicine.disease Psychiatry and Mental health Treatment Outcome Erectile dysfunction Reproductive Medicine Tolerability Vardenafil Physical therapy business medicine.drug |
| Zdroj: | The Journal of Sexual Medicine. 8:2904-2911 |
| ISSN: | 1743-6109 1743-6095 |
| DOI: | 10.1111/j.1743-6109.2011.02383.x |
| Popis: | Introduction The prevalence of erectile dysfunction (ED) is increased in men with metabolic syndrome compared with the general population. Aim The aim of this study was to evaluate the efficacy and safety of vardenafil vs. placebo in men who had ED and metabolic syndrome. Methods This was a 12-week, double-blind, randomized, multicenter, parallel-group, placebo-controlled prospective study in men with ED and metabolic syndrome (assessed by the International Diabetes Federation criteria). Vardenafil was administered at a starting dose of 10 mg, which could be titrated to 5 mg or 20 mg after 4 weeks, depending on efficacy and tolerability. Main Outcome Measures Primary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile (SEP) diary questions 2/3. Secondary efficacy measures included SEP1, a diary question assessing ejaculation, the percentage of men achieving “return-to-normal” erectile function, and the percentage of men who titrated to a different dose. Adverse events (AEs) were recorded throughout the study. Results The intent-to-treat population included 145 men (vardenafil, N = 75; placebo, N = 70). Baseline least squares IIEF-EF domain scores were low (vardenafil: 12.0; placebo: 12.7), indicative of moderate-to-severe ED. Vardenafil was statistically significantly superior to placebo for all primary efficacy measures (P Conclusions This is the first study to assess the efficacy and safety of vardenafil, taken alone, for ED therapy in a population of men who all had metabolic syndrome. Although baseline erectile function in these patients was low, vardenafil treatment was associated with significant improvements in erectile function and rates of successful intercourse, and was well tolerated. |
| Databáze: | OpenAIRE |
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