Vardenafil in Men with Stable Statin Therapy and Dyslipidemia

ArticleinJournal of Sexual Medicine 5(6):1455-67 · July 2008with66 Reads
DOI: 10.1111/j.1743-6109.2008.00820.x · Source: PubMed
Abstract
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. 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. 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. 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. 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 < 0.001). The LS adjusted mean IIEF-EF domain score for week 12 using LOCF was 21.99 in patients on vardenafil therapy vs. 14.83 in those on placebo (P < 0.001). The most commonly encountered AEs were headache and nasal congestion. 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.
    • "All three PDE5 inhibitors have demonstrated their efficacy and safety in patients with dyslipidemia . Specific data on vardenafil showed that it was effective in men with dyslipidemia regardless of LDL-C levels, total cholesterol/high-density lipoprotein cholesterol ratio [40]. "
    [Show abstract] [Hide abstract] ABSTRACT: Erectile dysfunction (ED) is a very common multidimensional disorder affecting men worldwide. Physical illness, reaction to life stresses, or an unhappy couple relationship influence clinical outcome. Phosphodiesterase type 5 (PDE5) inhibitors are recognized as efficacious and well tolerated, and are the first-line treatment for ED. Sildenafil, tadalafil, and vardenafil are the most widely used and studied PDE5 inhibitors. Data acquired during a routine diagnostic workup for ED should be taken into account when choosing the best PDE5 inhibitor for the individual patient, creating an individualized treatment plan, and going beyond "experience-based" subjective opinion and unfounded ideas and prejudice regarding currently available drugs. As the process of matching a given patient's profile to any selected PDE5 inhibitor often relies more on physician's personal convictions than on solid evidence, the aim of this review is to identify the main clinical, demographic, and relational factors influencing the choice of the PDE5 inhibitor to be used for the treatment of ED. A systematic literature search and current treatment guidelines were evaluated in a systematic manner. The main clinical, cultural, and demographical factors to be considered for the treatment of ED have been identified. Main factors influencing the choice of the treatment for ED have been described. A short list of items that may help in choosing the right PDE5 inhibitor for the treatment of different patients in daily clinical practice has been prepared. The simple algorithms prepared should be a useful tool to be used in daily practice, which may help in choosing the right treatment for each subject affected by ED.
    Full-text · Article · Dec 2011
    • "" ), and the TSS and GAQ (vardenafil ODT 72% vs. placebo 26%). These data regarding treatment satisfaction mirror those of studies using the film-coated tablet formulation of vardenafil [18,19,31]. The FINDER study found that 79% of men taking vardenafil responded positively to the GAQ after 12 weeks of treatment , compared with 38% of men receiving placebo [18]. "
    [Show abstract] [Hide abstract] ABSTRACT: Introduction. Orodispersible tablet (ODT) formulations offer improved convenience over film-coated formulations and are preferred by many patients. Aim. To investigate the efficacy and safety of an ODT formulation of 10 mg vardenafil administered on demand vs. placebo in a general population of men with erectile dysfunction (ED). Methods. This was a 16-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled study conducted at 40 centers across Europe and South Africa. Eligible participants were men aged ≥18 years with ED for at least 6 months, in a stable heterosexual relationship for at least 6 months, highly motivated to obtain ED treatment, and making at least four attempts at sexual intercourse on four separate days, of which at least half were unsuccessful. Subjects were randomized to receive 12 weeks of treatment with either 10 mg vardenafil ODT on demand or placebo, and each treatment group was stratified such that approximately half of the subjects were aged ≥65 years. Main Outcome Measures. Primary measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the Sexual Encounter Profile questions 2 and 3 (SEP2, SEP3). Secondary measures included SEP diary questions 1, 4, 5, and 6; the Treatment Satisfaction Scale; and the Global Assessment Question. Results. Of the 409 men enrolled (54.8% aged ≥65 years), 355 were included in the intent-to-treat population (vardenafil ODT, N = 183; placebo, N = 172). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy measures (all P < 0.0001). The incidence and type of treatment-related adverse events with vardenafil 10 mg ODT were comparable with those of the film-coated tablet formulation. Conclusions. Treatment with 10 mg vardenafil ODT, taken on demand, significantly improved erectile function and was well tolerated in a broad population of men with ED. Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, and Ewald S. The POTENT I randomized trial: Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med 2010;7:1497–1507.
    Article · Apr 2010
    • "It has been demonstrated that statin therapy to correct lipid levels improves penile rigidity in men with ED and hypercholesterolemia. 65 There are few studies evaluating the efficacy of PDE-5 inhibitors in men with ED and dyslipidemia. A 12-week, double-blind, placebo-controlled study investigated the efficacy of flexible-dose vardenafil in men with ED and dyslipidemia on stable statin therapy.28 In addition to dyslipidemia, 61% of subjects had hypertension and 40% had diabetes. "
    [Show abstract] [Hide abstract] ABSTRACT: Many men with erectile dysfunction (ED) also have associated underlying cardiovascular and metabolic conditions, for which they are likely to be taking medication. Therefore, cardiovascular safety and potential drug interactions are two of the major concerns when using PDE-5 inhibitors in these patients. The PDE-5 inhibitor, vardenafil, is characterized by a rapid onset of action, increased duration of erection, high rates of first-dose success and reliable efficacy that can be maintained with continued use. In both clinical trials and real-life observational studies, vardenafil has demonstrated a favorable efficacy and safety profile in men with ED, including those with associated underlying conditions such as diabetes, hypertension and dyslipidemia. Importantly, the concomitant use of medication for these conditions is not associated with any noteworthy changes in the efficacy and safety of vardenafil. The evidence presented in this review supports the use of vardenafil as a first-line treatment for men with ED, including those with underlying conditions.
    Full-text · Article · Dec 2009
Show more