Levitra (vardenafil) Info

Erectile dysfunction (ED) is a highly prevalent condition that has a major impact on the lives of millions of men and their partners, affecting sexual and psychological health and quality of life (QOL). Depending on the etiology, ED may indicate underlying systemic vascular or neurogenic disease that is often associated with the impairment of neurogenic and/or endothelium-dependent vasodilatory mechanisms, which in turn contribute to circulatory and structural changes in penile tissues. The resulting arterial insufficiency and defective smooth muscle relaxation in men with vascular comorbidities lead to an increased prevalence of ED in this patient population, which complicates disease management.

Most men with ED have concomitant comorbidities, and the etiology of disease in men with ED and comorbidities is more severe than in men who have ED alone. One particular study reported that up to 70% of men with ED also had one or more of the following comorbidities: hypertension, diabetes, dyslipidemia or depression. Data from a study by Greenstein and colleagues demonstrated a correlation between the severity of ED (assessed with a questionnaire introduced by O’Leary and colleagues) and the severity of coronary artery disease (CAD; classified according to the New York Heart Association functional classification). After a 30-day period during which patients were expected to maintain a normal pattern of sexual activity with their spouse or partner, the results showed that patients with CAD affecting only 1 coronary vessel had a significantly increased number of erections (p < 0.04), along with firmer erections (p < 0.001) and fewer difficulties in achieving an erection (p < 0.007), compared with men who had 2 or 3 coronary vessels involved.

First-time or rapid onset and continued success or reliability (the ability of a patient with ED to respond to subsequent therapy after an initial positive treatment response) are important criteria for selecting and continuing treatment in ED patients with comorbidities. Optimal ED therapy with a phosphodiesterase type 5 (PDE5) inhibitor would result in substantial initial response to therapy and provide consistent long-term reliability and improvement in overall QOL. The reliability of ED therapy therefore improves patients’ confidence in and compliance with it and may reduce the incidence of treatment discontinuation owing to lack of effect. In the Men’s Attitudes to Life Events and Sexuality (MALES) study, 47% of 3291 men with ED indicated that therapy reliability after initial response was among the most important characteristics of therapy, and 255 (22%) stated that they discontinued treatment because their medication only worked occasionally.

Demonstrating first-time dose success and reliability in ED populations is often challenging because of the complicating pathophysiology of the disease, which may be even more challenging to treat in men with comorbid conditions. The Reliability–Vardenafil for Erectile Dysfunction I (RELY-I) study showed that vardenafil 10 mg was highly successful as a first-dose therapy in terms of key erection function parameters and that it provided reliability for ED patients both with and without comorbid conditions. Similar in design to RELY-I and conducted simultaneously, RELY-II was a prospective, placebo-controlled, clinical trial designed to assess the first-time dose response and overall reliability of vardenafil 20 mg in men with ED and specific comorbidities that included hypertension, dyslipidemia and diabetes mellitus. In contrast to the men randomized in the RELY-I study, the patient population in the RELY-II study had a higher percentage of men with severe ED, including those with comorbidities.