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As first-line erectile dysfunction treatment for men, Levitra provides sexual satisfaction for couples


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Wednesday - April 5, 2006, Paris – In this first study of its kind in men with erectile dysfunction who had not previously been treated with a phosphodiesterase type 5 (PDE5) inhibitor, 81% of men who took Levitra (vardenafil) reported improved erections (81% with Levitra vs 30% who took a placebo; p<0.0001). 78% of men were able to maintain their erections to complete intercourse (known as SEP3, 78% with Levitra vs 41% with placebo, p<0.0001). Levitra is a couple’s solution, couples reported that the man’s treatment with Levitra significantly improved confidence (64% vs 41% for men; 60% vs 37% for partners), pleasure (67% vs 44% for men; 64% vs 38% for partners) and satisfaction with erection (60% vs 28% for men; 58% vs 27% for partners), orgasm (60% vs 32% for men; 56% vs 32% for partners) and with Levitra itself (62% vs 31% for men; 58% vs 30% for partners; all p<0.0001).
This 12-week, multicentre, randomised, double-blind, placebo-controlled study involved 260 men aged 18 years or older with ED for more than 6 months. The starting dose of vardenafil was 10 mg, which could be titrated to 5 mg or 20 mg. Two of the primary endpoints were response to the Global Assessment Question (GAQ, ‘Has the treatment you have been taking improved your erections?’) and positive response to SEP3 “Did you maintain your erection long enough to complete intercourse?”. The secondary efficacy measure included men and partners responses to questions on the Treatment Satisfaction Scale (TSS).1
“Successful therapy for erectile dysfunction with Levitra benefits both partners. Couples agree that Levitra provides better erections allowing men to confidently respond to their partners.” reports Dr. David Edwards of White House Surgery, Chipping Norton, UK and a primary investigator for this study.


About Erectile Dysfunction

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance.2 It is estimated that some degree of ED affects about half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED.3 The number of men with ED is expected to more than double to 322 million by 2025.4 Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated.5


References

1. A-549. Edwards D et al. Vardenafil improves satisfaction in couples affected by erectile dysfunction previously untreated with PDE5 inhibitors. EAU Poster presentation: Thursday, 6 April, 2006 15.45-17.15 Room Ternes, Palais de Congress, Paris, France
2. Jardin A, Wagner G, Khory S et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-sponsored by the World Health Organisation (WHO), International Consultation on Urological Diseases (ICUD) and Societé Internationale D’Urologie (SIU). p.713
3. Rosen RC, Fisher W, Eardley I, Neiderberger C, Nada A, Sand M: The Multinational Men’s Attitudes to Life Events and Sexuality (MALES) Study I, Prevalence of Erectile Dysfunction and Related Health Concerns in the General Population. Cur Med Res Op.
4. Aytac IA, McKinlay JB, Krane RJ: The likely world increase in erectile dysfunction between 1995 and 2065 and some possible policy consequences. BJU International 1999; 84:50-56
5. Southgate J: New rivals to Viagra expand the market. Scrip World Pharmaceutical News, 2002


About Bayer HealthCare AG

Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.


Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.



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