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Title: Vardenafil Improves Sexual Function Regardless of Age: Presented at AGS

"Vardenafil Improves Sexual Function Regardless of Age: Presented at AGS"

By Emma Hitt BALTIMORE, MD -- May 17, 2003 -- Vardenafil appears to improve sexual function regardless of age, according to a retrospective analysis of data from two phase III trials. Craig Donatucci, MD, with Duke University Medical Center, Durham, North Carolina, reported the findings here on May 15th at the Annual Meeting of the American Geriatrics Society. A previous pooled analysis of two trials found that vardenafil improved erections up to 85% regardless of age on measures including international index of erectile function (IIEF) scores and successful maintenance rates. Dr. Donatucci and colleagues analysed two phase III studies to assess the impact of age on additional parameters related to the quality of erections that are "important to patients' perceptions regarding erection quality and satisfaction." A total of 1,479 men who experienced erectile dysfunction for at least 6 months were enrolled; 350 receive vardenafil at a dose of 5 mg, 358 received 10 mg, 351 received a 20 mg dose, and 342 received placebo. Treatment was continued for 12 weeks. Efficacy variables included patients' reports of satisfaction with erection hardness and sexual experience, ejaculation, and IIEF-intercourse satisfaction/orgasmic function domains. Results were evaluated according to age groups: younger than 45 years; 45 to 65 years; and 65 years or older. Vardenafil at a dose of 10 mg or 20 mg significantly improved all measures of efficacy (P<0.05 compared to placebo) across all age groups. Furthermore, age did not significantly influence erection hardness satisfaction (P=0.08), ejaculation (P=0.40) or IIEF intercourse/orgasmic domains (P=0.17/P=0.30), Dr. Donatucci reported. Men who were younger than 65 years reported a slightly higher improvement in satisfaction with their sexual experience than older men, however (P=002). According to the researchers, the most common treatment-related adverse events were headache, rhinitis and flushing, but these were not consistently more frequent in men 65 years or older. Serious adverse events occurred in 3.8% of placebo patients; 3.8% of the 5 mg vardenafil group; 5.8% of the 10 mg group; and 3.5% of the 20 mg vardenafil group. They included hernia, accidental injury, chest pain, and hyperglycemia, and were also seen with similar frequency across age groups. A second analysis presented by Dimitrios Hatzichristou, MD, with Aristotle University of Thessaloniki, Greece, and colleagues evaluated the efficacy of vardenafil in a flexible-dose regimen, a situation "more likely to be encountered in clinical practice." They evaluated 309 men with erectile dysfunction who were older than 18 years. Patients were first randomised to receive placebo or 10 mg vardenafil. At the 4- and 8-week visits patients were evaluated and either remained at the 10 mg dose or were switched to a 5 mg or 20 mg dose. Of those choosing to remain on the 10 mg dose, 92% responded positively to the question "has the treatment you've been taking over the past 4 weeks improved your erections?" However, further improvement was seen in those choosing to titrate up to the 20 mg dose, in which 100% of patients responded positively. "Vardenafil was efficacious regardless of the dose chosen," the researchers concluded. Both studies were funded by Bayer Corporation and GlaxoSmithKline, marketers of vardenafil under the tradename Levitra®. [Study Title: Vardenafil Improved Satisfaction with Erection Hardness, Orgasmic Function, and Sexual Experience in Men with Erectile Dysfunction Irrespective of Age. Abstract P167]

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