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The Pharmaceutical Journal Vol 267 No 7155 p3-8
July 7, 2001

Research and Development summary


Vardenafil improves erectile function in men with diabetes

VARDENAFIL, a phosphodiesterase-5 inhibitor, improves erectile dysfunction in men with type 1 and type 2 diabetes, according to data from a phase III study. Data were presented last month at the 61st Annual American Diabetes Association Scientific Sessions.

The study involved 452 men aged 18 and older with mildly to severely impaired erectile function who were randomised to receive vardenafil 10mg or 20mg, or placebo on demand. Dr I. Goldstein, Boston University Medical School, Massachusetts, and colleagues found that 72 per cent of participants in the 20mg group reported an improvement in erectile dysfunction compared with 13 per cent in the placebo group. Participants in the 10mg group showed a 57 per cent response rate.

Bayer plans to submit a licence application for vardenafil for erectile dysfunction in the second half of 2001 and expects to receive approval during the second half of 2002.

A topical treatment for erectile dysfunction containing the vasodilator glyceryl trinitrate is also in development. The cream, MED2001, can be used by patients taking nitrate therapy in whom phosphodiesterase inhibitors, such as sildenafil (Viagra) and vardenafil, are contraindicated. Futura Medical, the company developing the product, says that it expects to submit an application to the Medicines Control Agency for approval of MED2001 in late 2002.

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