Bayer Schering Pharma Presents Innovations in Men’s Healthcare at the 22nd Annual Meeting of the European Association of Urology (EAU)

Berlin, Germany – Bayer Schering Pharma AG, Germany, highlighted their expanded new offerings in Men’s Healthcare during a press conference held at the 22nd Annual Meeting of the European Association of Urology (EAU) on March 22, 2007. The event focused on study results from their three products: Levitra®, Testogel® and Nebido®.

The Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy (REPEAT) study (1) has been designed to help researchers determine why over 50% of couples experiencing sexual problems discontinue treatment. This three year, innovative post marketing surveillance (PMS) study will follow men treated with Levitra® and their female partners in over 20 countries for 12 months. Understanding the couple’s attitude, perception and behaviour during treatment are crucial to good outcomes in PDE-5 therapy such as Levitra®.

Bayer Schering Pharma will use results from REPEAT as a part of their award-winning patient education programmes to help couples continue on treatment. This study is a further example of Bayer Schering’s commitment to ensure that Levitra® helps couples around the world; and follows on from the world-wide release of the very positive results of the Real-Life Safety and Efficacy of Vardenafil (REALISE) study (2). The REALISE study, the largest study of erectile dysfunction (ED) in the world, a PMS study covering 50 countries, 30,000 investigators and over 100,000 patients showed Levitra® to be efficacious and safe when used in the real-world.

“The results obtained from REPEAT will be extremely useful in understanding the interaction between patient, partner and physician when seeking treatment for erectile problems and what can be done to assist men and their partners to achieve optimal results. More importantly, it will help us to establish why some men discontinue treatment even though they continue to suffer from ED. ED can have a huge impact on a relationship and exploring these issues will help healthcare professionals to assist their patients to choose the best treatment” said Hermann Van Ahlen, MD, Professor of Urology, University of Muenster, Germany.

Levitra® is a proven ED treatment to help men and their partners. The COUPLES study (3), also released today at the EAU, compares patient and partner satisfaction with Levitra® as measured by the TSS (Treatment Satisfaction Scale) by exploring pooled results of three multi-centre 12-week randomised, double-blind, placebo-controlled studies of flexible-dose vardenafil versus placebo. Couples agree that Levitra® provided significantly greater satisfaction versus placebo and that satisfaction is achieved by not only to the man, but also to his partner.

The Levitra® CONFIRMED study was undertaken to compare the efficacy and safety of vardenafil (Levitra®) to that of sildenafil (Viagra®) when used on demand in a population of men with ED. The CONFIRMED study demonstrates the non-inferiority of Levitra® in comparison to Viagra® for overall preference and nominal statistical superiority of Levitra® to Viagra® for several frequently used efficacy variables. The results in a total of 1057 men who were randomised to treatment, showed that 38.9% of men expressed an overall preference for Levitra® over Viagra® (34.5%) and 26.6% of patients had no treatment preference. The difference found was not statistically significant. Regarding secondary measures, Levitra® achieved better response for men responding to the Sexual Encounter Profile questions 2 and 3; 83.9% of men taking Levitra® responded positively to SEP2 (p=0.0389) compared with 82.28% for Viagra® and 74.4% of men preferred Levitra® in response to SEP3 (p=0.0038) against 71.6% for Viagra®. 4

The CONFIRMED study avoided biases seen in other comparative trials by consciously creating an unbiased methodology that included 13 separate criteria. Beyond the randomised, double-blind, cross-over design, this trial additionally used equivalent drug doses, randomised the treatment sequence, used a neutral consent form, assessed preference after each treatment period and, importantly, did not eliminate previous non-responders or only include naïve patients.(4)

Levitra® may also be safe and effective in lessening the symptoms of bothersome lower urinary tract age related symptoms such as urgency and frequent urination. An in-vivo study released at the EAU, shows that Levitra® induced significant relaxation of the lower urinary tract tissues, inhibiting the proliferation of human prostate stroma cells and reducing the irritating symptoms of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) (5). The study investigators concluded that Levitra® could be developed to be used as an effective treatment of BPH/LUTS.

For many men, testosterone levels decline naturally as they age. This effect goes unnoticed and is often regarded as a natural phenomenon of aging. However, low testosterone levels can have a serious effect on the quality of life of men and is commonly associated with a decrease in libido, lean body mass and bone density and an increase in visceral fat as well as disturbances in well-being and mood. Eight centres in Austria, Finland, Germany, Ireland, Spain, Sweden and UK recruited 365 patients with decreased testosterone levels and hypogonadal symptoms in this multi-centre, placebo controlled, double-blind, randomised study(6). This study found that treatment with Testogel®, a transdermal 1% hydroalcoholic gel restored testosterone levels in hypogonadal men to normal range. Testogel® treatment had a statistical significant effect on lean body mass versus placebo. Body composition was also favourably influenced by Testogel® treatment compared to placebo.

Nebido®, an intramuscular depot formulation of testosterone undecanoate, can provide safe and effective drug treatment with high satisfaction for men. An open label prospective, one arm study in 16 centres in Germany included 96 hypogonadal patients, with a mean age of 48.6 years. The men received 6 injections of Nebido® over a period of 63 weeks. The results showed that Nebido® not only improved the lipid pattern (reduction of total cholesterol and LDL cholesterol) as well as glycaemia control (levels of blood sugar) but also improved psychological, somatic, and sexual symptoms of testosterone deficiency. There were no clinically relevant side effects and 92.5% of patients assessed treatment with Nebido® as satisfying.(7)

Abstracts and further information about all of the studies will be available on the Levitra® World of Flame press centre. For a copy of the materials, please visit www.world-of-flame.info/en/press.