PDE5 Inhibitors

Treatment with PDE-5 inhibitor shows improvements in several satisfaction domains

The phosphodiesterase type-5 inhibitor vardenafil (Levitra) significantly improves sexual pleasure and treatment satisfaction in both men with erectile dysfunction and their partners. according to study results presented at the European Association of Urology annual congress here.

More than one-half of all men older than age 40 years are estimated to have some degree of ED. Yet, only 10% of the approximately 30 million men affected in the United States seek treatment for the condition. For the majority of those who do, PDE-5 inhibitors—sildenafil citrate (Viagra), tadalafil (Cialis), and vardenafil—are recognized as first-line therapy for ED management.

“In this report, the rote and impact of the partner is highlighted and clearly shows that effective treatment of male erectile dysfunction yields measurable improvements in partner sexual satisfaction,” said study co-author Gerald Brock, MD, associate professor of urology at St. Joseph’s Medical Center, Lawson Research Institute, London, Ontario, Canada. “While often ignored, ultimately successful erectile dysfunction treatment satisfaction of the male requires that the partner obtains an enhanced experience as well.”

To assess the efficacy of vardenafil on various parameters of sexual function and pleasure, researchers from the University of Western Ontario, London, Canada, evaluated 229 males (aged 18 years and older) with ED and their female partners (aged older than 18 years) without sexual dysfunction in a 12-week multicenter, double-blind, randomized trial. All participants had been in a stable relationship with their respective partner for more than 6 months.

Men in the study were randomized to placebo or vardenafil, 10 mg for 4 weeks, with an option to continue receiving the 10-mg dose or titrate to 5 mg or 20 mg after each of the first two consecutive 4-week intervals.

Primary efficacy endpoints were mean patient success rate of erection maintenance for satisfactory completion of intercourse (sexual encounter profile [SEPl-3) and improvement of the partner’s sexual quality of life, measured as the QoL domain on the modified Sexual Life Quality Questionnaire (mSLQQ-QoL).

Secondary endpoints – confidence, ease ot erection, pleasure, and satisfaction of erectile function, orgasm, and medicationincluded responses to a treatment satisfaction scale (TSS) developed and validated in three previous trials.

Mean baseline erectile function domains were 13.2 and 13.5 (ie, moderate ED) in the placebo and vardenafil groups, respectively. The investigators reported that vardenafil significantly improved overall mean patient SEP-3 success rates (68%; baseline, 20%), compared with placebo (28%; baseline, 21%,p<.0001), as well as partner mSLQQ-QoL (66%; baseline, 28% vs. 32%; baseline, 26%, respectively;p<.0001, last observation carried forward).

Several domains improved

Vardenafil, compared with placebo, improved all TSS domains in a clinically and statistically significant manner:

• confidence of the patient (60% vs. 26%) and partner (58% vs. 21%)
• ease of erection in the patient (61% vs. 35%) and perception of ease of erec tion of the partner (61 % vs. 31 %)
• pleasure in the patient (65% vs. 38%) and partner (63% vs. 40%)
• erectile function satisfaction of the patient (53% vs. 11%) and perception of erectile function satisfaction of the partner (53%; vs. 17%)
• orgasm satisfaction of the patient (61 % vs. 28%) and partner (61 % vs. 37%)
• medication satisfaction of the patient (54% vs. 9%) and perception of medication satisfaction of the partner (53% vs. 11%).

In general, vardenafil was well tolerat ed. Flushing, headache, nasal congestion, and dyspepsia were the most frequently reported adverse events.

“We’ve seen that a PDE-5 inhibitor—in this case, vardenafil—resulted in improvement in many treatment and pleasure European parameters, including Association orgasmic satisfaction of Urology not only in the patient, but also in the partner,” said Ajay Nehra. MD. Istanbul. Turkey professor of urology at the Mayo Clinic, Rochester, MN, who was not affiliated with the study. ‘The bottom line here is that erectile dysfunction is a couple’s issue.”

Dr. Nehra added that the results of the Female Experience of Men’s Attitudes to Life Events and Sexuality (FEMALES) study also demonstrated that the presence of sexual dysfunction in a male has a negative effect on the sexual experience of the female partner.

“Women interviewed in FEMALES reported reduced frequency of sexual activity, loss of desire, lack of arousal, and inability to get orgasm and satisfaction with men who have erectile difficulties,’” he said. “It thus appears that the couple is adversely affected with the onset of ED.”

Dr. Brock serves as an adviser to Pfizer, Eli Lilly, Bayer, GlaxoSmithKline, and Sanofi-Aventis.