Vardenafil in Men with Stable Statin Therapy and Dyslipidemia
| Autor: | Katie L Dawson, Eric Beresford, David O. Cook, Martin Miner, Marisha Stanislaus, James Bailen, Allison Barnes, Larry I. Gilderman |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Phosphodiesterase Inhibitors Urology Endocrinology Diabetes and Metabolism Population Placebo Piperazines law.invention Endocrinology Double-Blind Method Erectile Dysfunction Vardenafil Dihydrochloride Randomized controlled trial law Internal medicine Diabetes Mellitus Humans Medicine Prospective Studies Sulfones Prospective cohort study education Dyslipidemias education.field_of_study Triazines business.industry Coitus Imidazoles Middle Aged medicine.disease United States Clinical trial Psychiatry and Mental health Treatment Outcome Erectile dysfunction Reproductive Medicine Vardenafil Hypertension Physical therapy Hydroxymethylglutaryl-CoA Reductase Inhibitors business Dyslipidemia medicine.drug |
| Zdroj: | The Journal of Sexual Medicine. 5:1455-1467 |
| ISSN: | 1743-6095 |
| Popis: | Introduction Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for their efficacy and safety in various clinical trials in men with erectile dysfunction (ED) with or without associated comorbidities. Aim This is the first prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a PDE-5 inhibitor (i.e., vardenafil) in an exclusive population of men with ED and dyslipidemia. Main Outcome Measures Three coprimary efficacy measurements (Sexual Encounter Performance [SEP]2, SEP3, International Index of Erectile Function-Erectile Function [IIEF-EF] domain scores) were used to assess the differential effect of vardenafil vs. placebo in this patient population. Adverse events (AEs) safety data were obtained to compare safety outcomes. Methods This 12-week of randomized, double-blind, placebo-controlled study was conducted in 59 U.S. centers. Patients received either on-demand, flexible-dose vardenafil 10 mg (titrated to 5 mg or 20 mg based upon efficacy and safety) or placebo. Results Of the 712 patients screened and entered into the study, 395 were randomized. Baseline demographics for the intent-to-treat population included: mean age, 54.4 years (±7.5 standard deviation [SD]); 76% Caucasian; mean body mass index (BMI), 31.7 kg/m 2 (±12.7 SD); 47% past/present smoker; and 42% severe ED. Aside from dyslipidemia, other comorbidities included hypertension, 61%; obesity (i.e., BMI ≥ 30), 51%; and type 1 or 2 diabetes, 40%. During the 12-week treatment period, the least squares (LS) adjusted mean success rates in patients on vardenafil vs. placebo were: SEP2, 79.09% vs. 51.92%; and SEP3, 66.69% vs. 33.83% ( P P Conclusions Vardenafil was demonstrated to be safe and effective for managing ED in men with ED and associated dyslipidemia. The results of this study support the role of expanded research on outcomes related to effective ED treatment and aggressive lipid control. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M, Beresford E, and Barnes A. Vardenafil in men with stable statin therapy and dyslipidemia. |
| Databáze: | OpenAIRE |
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