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| |  ESSIR: Vardenafil Improves Erectile Function In Patients With Diabetes ROME, ITALY -- October 2, 2001 -- Data being presented at the Fourth Annual European Society for Sexual and Impotence Research (ESSIR) conference in Rome this week demonstrate that vardenafil showed a statistically significant improvement in erectile function for men with diabetes and erectile dysfunction (ED) (1), a population that generally has been less responsive to current oral ED therapies. "In an extensive clinical trial programme, vardenafil has consistently shown positive results across many populations regardless of age, severity, or cause of erectile dysfunction," said Dr. Irwin Goldstein, Boston University School of Medicine, lead investigator of the study and member of the International Vardenafil Study Group. "For example, men with diabetes - who are three times more likely to have ED because of their condition - are usually less responsive to oral ED treatments. A Phase III study proved this not the case with vardenafil. This study of 452 men with type 1 and type 2 diabetes showed improved erections in 72 percent of patients who took vardenafil, in comparison to only 13 percent of patients on placeb," Dr. Goldstein said. According to Diabetes UK, the leading charity working for people with diabetes in Great Britain, over 1.4 million people there have diabetes and another million probably have the condition but don’t know it (2). The charity says "Impotence is a deeply distressing condition. Effective treatments offer people with diabetes who suffer from impotence, and their partners, the opportunity to resume and continue active sexual lifestyles and this should not be restricted (3)". Vardenafil is a highly potent and selective phosphodiesterase-5 inhibitor being developed by Bayer. Results from a large-scale Phase II study also presented at the ESSIR, demonstrated that vardenafil has efficacy across the broad population of men who have experienced a loss of erectile function. The study (4) showed that vardenafil improved erections in up to 80 percent of the 580 men evaluated. Vardenafil was also shown to provide a significant benefit within four weeks (the earliest point of measurement), a benefit which was consistently maintained over the three months of the study. Last week, Bayer submitted vardenafil for regulatory approval in the United States and Mexico. The company is expecting to gain marketing approval for vardenafil in those countries in the second half of 2002 and in the European Union in 2003. References: SOURCE: Bayer
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