Room 519-A | Sexual Dysfunction (ED) Monday, July 11, 2005 Time: 8:30 AM-10:30 AM |
Vardenafil improves erectile function and sexual quality-of-life in men with ED and their partners.
Rosen, Raymond1, Fisher, William*,2, Brock, Gerald3, Karlin, Gary4, Pommerville, Peter5, Huang, Xing-Yue 6, Bangerter, Keith7, Bandel, Tiemo-Joerg8, Sand, Michael*,6, Derogatis, Leonard , 1 Robert Wood Johnson Medical School, New Brunswick, NJ, USA2 University of Western Ontario, London, Ontario, Canada3 St Joseph's Medical Center, London, Canada4 Lawrenceville Urology Practice, Lawrenceville, NJ, USA5 Victoria General Hospital, Victoria, Canada6 Bayer Healthcare Pharmaceuticals, West Haven, CT, USA7 Bayer Healthcare Pharmaceuticals, West Haven, CT, USA8 Bayer Healthcare AG, Wuppertal, Germany
ABSTRACT- Introduction & objectives: Although erectile dysfunction (ED) is a disease that affects couples, few data are available on the effect of ED treatment on quality of life (QoL) of ED patients and their partners. The influence of vardenafil on the success rate of efficacy parameters important to patient and partner, including erectile function and sex-related QoL was assessed. Methods: In a double-blind, multicenter, 12-week randomized trial, 229 men with ED received placebo (PLA) or vardenafil (VAR) 10 mg for 4 weeks, with option to stay on 10 mg, or titrate to 5 mg or 20 mg after each of two consecutive, 4-week intervals. Female partners (n=229) of these ED males were also enrolled, age >18 years without sexual dysfunction. The primary efficacy variables were the mean/patient success rate of erection maintenance to intercourse completion (Sexual Encounter Profile question 3 [SEP3]), and improvement of partner's sexual quality of life (partner's response to the QoL domain of the modified Sexual Life Quality Questionnaire [mSLQQ-QoL]). Secondary efficacy variables included patient responses to the mSLQQ-QoL. Differences between groups (intent-to-treat [ITT] population) were determined by analysis of covariance. Results: Mean baseline International Index of Erectile Function - erectile function (IIEF-EF) domain score was 13.1 for VAR (n=114) and 13.4 (n=113) for PLA. The overall least-square (LS) mean per-patient SEP3 success rates in those receiving VAR was significantly higher vs PLA (67.7% [baseline 19.8%] vs 27.8% [baseline, 21.2%], respectively, p<0.0001). The LS mean mSLQQ-QoL domain score of female partners of men receiving VAR was significantly higher compared to female partners of men receiving PLA (65.8 vs 32.1, p<0.0001, LOCF). The LS mean mSLQQ-QoL domain score of men receiving VAR was significantly higher vs PLA (63.9 vs 28.4, p<0.0001, LOCF). VAR was generally well tolerated. The most frequently reported adverse events included flushing, nasal congestion, headache, and dyspepsia (all <12%). Conclusions: VAR significantly improved erectile function and sexual QoL for the ED patient and his partner. Improvement in sexual QoL for patients and their partners should encourage couples to seek and continue ED therapy.
Key words: erectile dysfunction, PDE-5 inhibitor, vardenafil, partner, satisfaction