Room 519-A | Sexual Dysfunction (ED) Monday, July 11, 2005 Time: 8:30 AM-10:30 AM |
Vardenafil 10mg Improves Satisfaction with Sexual Function and Treatment in Men with Erectile Dysfunction.
Valiquette, Luc*,1, Patel, Vaishali2, Mahajan, Sunny3, Stancil, Britt-Nicole4, Edmunds, Katharine5, 1 Hôpital St-Luc du CHUM, Montréal, Québec, Canada2 GlaxoSmithKline, King of Prussia, PA, USA3 GlaxoSmithKline, NC, USA4 GlaxoSmithKline, NC, USA5 GlaxoSmithKline, Harlow, UK
ABSTRACT- Background: Treatment satisfaction scale (TSS) is a validated instrument to measure erectile dysfunction (ED) treatment satisfaction. The 'on-treatment' version has six domains: ease of erection (EE), satisfaction with erectile function (SE), pleasure from sexual activity (PL), satisfaction with orgasm (SO), sexual confidence (SC), and satisfaction with medication (SM, not in 'unmedicated' version). Objective: The primary objective was to evaluate the efficacy, safety, and reliability of vardenafil 10mg compared with placebo in subjects with ED and a demonstrated successful first response. Satisfaction was assessed as a secondary endpoint, using the TSS. Methods: Men who responded to a single challenge dose of vardenafil 10mg were randomized to receive double-blind vardenafil 10mg or placebo for 12 weeks (primary results presented previously). The unmedicated version of the TSS was administered before the challenge dose (baseline). The on-treatment version was administered at Weeks 4, 8, and 12, or at premature discontinuation. Results: Of the 600 subjects who received the vardenafil challenge dose, 260 responders were randomized to vardenafil and 263 to placebo. Baseline characteristics were similar between groups. Mean age was 54 years and most were Caucasian (77%). Most men had severe (24%) or moderate (35%) ED, and comorbid conditions included hypertension (27%), dyslipidemia (19%), and diabetes (14%). For the primary endpoint (reliability of penetration), vardenafil was significantly superior to placebo (83% and 56%, respectively, p<0.001). At baseline, treatment groups were similar for each of the TSS subscales (least square mean). At study end (LOCF) there was a significant difference between the two groups for vardenafil for the six subscales (p<0.0001). Values in the vardenafil and placebo groups, respectively, for each of the domains were: EE, 59.92 vs. 38.42; SE 55.07 vs. 27.00; PL, 65.29 vs. 40.90; SO, 60.55 vs. 35.06; SC 61.81 vs. 37.51, SM, 27.05 vs. 58.46. Vardenafil was generally well tolerated; the most common adverse events (vardenafil vs. placebo) were headache (5% vs. 1.9%) and flushing (5.4% vs. 0.8%). Conclusion: There was a clinically and statistically significant superiority for vardenafil compared to placebo, for the primary endpoint of the reliability of insertion, as well as the secondary endpoint of treatment satisfaction.
Key words: erectile dysfunction, vardenafil, PDE5 inhibitor, reliability, satisfaction