Levitra®-Therapy suitable for men with High Cholesterol

Milan/Berlin, March 2008 – At the 23rd Annual European Association of Urology (EAU) Congress, results were presented which added evidence that Levitra® (vardenafil HCI) works very well in men with dyslipidemia.(1) The double-blind, placebo-controlled trial in about 400 men showed that Levitra® significantly improved the ability of men with erectile dysfunction (ED) and high cholesterol, to achieve and maintain an erection for successful sexual intercourse.(2) The trial, led by Dr. Martin Miner, clinical associate professor of family medicine at Brown University, Swansea, Massachusetts, was the first prospective study designed to evaluate Levitra’s safety and efficacy in patients with dyslipidemia (high cholesterol) and ED. All trial participants were taking statins to control their dyslipidemia. The results of the 12-week trial showed that men randomized to receive Levitra® had significantly increased success rates of penetration and the ability to maintain an erection compared to placebo.

“Erectile dysfunction is very often associated with high cholesterol. Many physicians are not treating ED, a life-changing condition”, said Mr. Ian Eardley, consultant urologist and honorary senior lecturer at St. James University Hospital, Leeds. “This study provides further support that Levitra® can successfully treat ED, even in men with a serious underlying condition like high cholesterol. Nearly 70% of men with ED have an underlying condition such as high blood pressure, diabetes or high cholesterol levels. The accumulating evidence shows that Levitra® is a potent treatment for ED in men with underlying conditions”, he emphasized at the EAU congress in Milan.

ED and testosterone deficiency often share the same underlying conditions such as dyslipidemia, cardiovascular disease and obesity. The presence of ED should automatically trigger tests to establish testosterone levels, as testosterone deficiency is a significant detriment to quality of life.

Also presented at the EAU in Milan, new data from the European Testogel®-Study, which showed that testosterone therapy with Testogel® may improve cardiovascular and metabolic conditions and quality of life in men with low testosterone (hypogonadism).(3) In the international, multicenter, randomized, double-blind, placebo-controlled study, 362 men aged 50-80 with late on-set hypogandism (LOH), i.e. testosterone deficiency associated with aging, were randomized to receive Testogel® or placebo for 6 months, followed by a 12-month open-label phase during which all patients received Testogel.

Over the first six months, Testogel® use was associated with significant improvements in cardiovascular and metabolic profiles, as well as quality-of-life scores as measured by the aging male symptom scale (AMS) compared to placebo. Once all study participants were using Testogel® the difference between the two groups narrowed considerably to a point where there was little difference between the study participants’ scores on the total AMS and sexual subscale, or between their cardiovascular and metabolic profiles. The study concluded that testosterone therapy may offer benefits for men’s overall health and be associated with improvements in cardiovascular and metabolic profiles and quality of life in men with LOH.

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1 Miner M. Vardenafil Efficacy and Safety in Men With Erectile Dysfunction and Dyslipidemia: A 12-Week, Randomized, Placebo-Controlled Trial. Abstract presented at Sexual Medicine Society of North America Fall Meeting, December 2007, Chicago, USA.

2 Miner M, and Billups KL. Erectile dysfunction and dyslipidemia: Relevance and role of phosphodiesterase type-5 inhibitors and statins. J Sex Med 2008;5(suppl 1):4-41

3 Bouloux PM et al. Testosterone therapy in men with late-onset hypogonadism: the benefits for men‘s overall health. Data presented at the Bayer Schering Pharma Symposium at the 23rd annual congress of the EAU, Milan, Italy, March 2008.