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The Pharmaceutical Journal Vol 267 No 7173 p667-671
10 November 2001

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New erectile dysfunction drug useful in diabetes

Vardenafil, a treatment for erectile dysfunction, will be especially useful in the treatment of men with diabetes, according to new data.

Results from a new study suggest 61 per cent of men with diabetes using the 10mg dose of the phosphodiesterase (PDE) inhibitor achieved successful penetration compared with 36 per cent of men with diabetes taking placebo. The phase III randomised placebo controlled trial examined the effects of vardenafil in 452 patients with both type 1 and type 2 diabetes.

Professor Irwin Goldstein, professor of urology at Boston University School of Medicine, explained: "Demonstrating successful penetration in this difficult-to-treat type of patient is OK. But what is vital is to prove that the erection can be maintained." Further analysis of the data showed that 49 per cent of men taking 10mg of vardenafil were able to maintain their erection compared with 9 per cent of those using placebo. The diabetes study follows trials in mixed populations of men with erectile dysfunction that showed that 75 per cent of men on vardenafil were able to achieve erections long enough to complete sexual intercourse.

Dr Ian Eardley, consultant urologist at St James's University Hospital in Leeds said the improved PDE-5 selectivity of vardenafil means it is less likely to cause the retinal disturbances seen in some patients taking sildenafil.

Vardenafil is one of two phosphodiesterase inhibitors in development, the other being tadalafil. Dr Eardley added: "Both new compounds look to be more potent than sildenafil."

Vardenafil is expected to enter the European regulatory process this year and to be launched at the end of 2002. Bayer hopes that vardenafil's trade name will be Nuviva. The trial results were presented at an international press briefing in Mexico City on 3 November.
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