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Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial.
J Sex Med. 2011 Oct; 8(10):2904-11.JS

Abstract

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 < 0.0001) and showed nominally statistically significant superiority compared with placebo for SEP1/ejaculation success rates (P = 0.0003 and P < 0.0001, respectively) and the percentage of subjects reporting "return-to-normal" erectile function (P = 0.0004). Treatment-emergent AEs were mild-to-moderate in severity and consistent with the known AE profile of phosphodiesterase type 5 inhibitors.

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.

Authors+Show Affiliations

PUR/R Praxisklinik Urologie Rhein-Ruhr, Mülheim an der Ruhr, Germany. t.schneider@pur-r.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21771281

Citation

Schneider, Tim, et al. "Efficacy and Safety of Vardenafil for the Treatment of Erectile Dysfunction in Men With Metabolic Syndrome: Results of a Randomized, Placebo-controlled Trial." The Journal of Sexual Medicine, vol. 8, no. 10, 2011, pp. 2904-11.
Schneider T, Gleissner J, Merfort F, et al. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011;8(10):2904-11.
Schneider, T., Gleissner, J., Merfort, F., Hermanns, M., Beneke, M., & Ulbrich, E. (2011). Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. The Journal of Sexual Medicine, 8(10), 2904-11. https://doi.org/10.1111/j.1743-6109.2011.02383.x
Schneider T, et al. Efficacy and Safety of Vardenafil for the Treatment of Erectile Dysfunction in Men With Metabolic Syndrome: Results of a Randomized, Placebo-controlled Trial. J Sex Med. 2011;8(10):2904-11. PubMed PMID: 21771281.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. AU - Schneider,Tim, AU - Gleissner,Jochen, AU - Merfort,Frank, AU - Hermanns,Monika, AU - Beneke,Manfred, AU - Ulbrich,Ernst, Y1 - 2011/07/19/ PY - 2011/7/21/entrez PY - 2011/7/21/pubmed PY - 2012/2/4/medline SP - 2904 EP - 11 JF - The journal of sexual medicine JO - J Sex Med VL - 8 IS - 10 N2 - 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 < 0.0001) and showed nominally statistically significant superiority compared with placebo for SEP1/ejaculation success rates (P = 0.0003 and P < 0.0001, respectively) and the percentage of subjects reporting "return-to-normal" erectile function (P = 0.0004). Treatment-emergent AEs were mild-to-moderate in severity and consistent with the known AE profile of phosphodiesterase type 5 inhibitors. 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. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/21771281/Efficacy_and_safety_of_vardenafil_for_the_treatment_of_erectile_dysfunction_in_men_with_metabolic_syndrome:_results_of_a_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33290-2 DB - PRIME DP - Unbound Medicine ER -