Vardenafil in Men with Stable Statin Therapy and Dyslipidemia

Abstract

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/m2 (±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. 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.

Stopwatch-assessed duration of erection: a new measure of the efficacy of erectile dysfunction treatments

“…39 A total of 386 men participating in this study, 35% of whom had moderate ED and 42% severe ED, were included in the intent-to-treat population. During the 12-week treatment period, men receiving flexible-dose vardenafil reported adjusted mean duration of erection leading to successful intercourse of 10.0 min compared with 3.4 min in those receiving placebo (po0.001).…”

“…Other efficacy measures, including the SEP-2 and SEP-3 responses and IIEF-EF domain scores, were primary efficacy end points in the dyslipidemia study and secondary end points in the ENDURANCE study. Characteristics of both studies are summarized in Table 1 and methodologies are fully described in Rosenberg et al 38 and Miner et al 39 Of note, ENDURANCE was a fixed-dose (10 mg), 4-week crossover study, whereas the dyslipidemia study used a flexible-dose (5/10/20 mg), 12-week parallel group design. Both were randomized, placebo controlled and double blind.…”

“…No adjustments for multiple comparisons were made for the secondary end point analyses. Detailed statistical methods are provided in Rosenberg et al 38 and Miner et al 39 …”

“…The same stopwatch approach was also used as a secondary end point to evaluate the efficacy of either on-demand, flexible-dose vardenafil or placebo in a population of men with ED and a higher proportion of comorbidities, all of whom had received a diagnosis of dyslipidemia and required statin therapy (the dyslipidemia study). 39 This paper highlights the results of these two prospective studies. In addition, it highlights the consistency of data obtained across studies using this approach, and their validation with respect to the more traditional self-assessment questionnaires.…”

“…Most AEs were mild to moderate in intensity, with headache and flushing being the most frequently reported. A more detailed discussion of treatment-emergent AEs and serious AEs was provided in Rosenberg et al 38 and Miner et al 39 …”