London, 25 February 2002 -- New results from clinical studies into the efficacy and safety profile of dutasteride, a new dual 5-alpha-reductase inhibitor (5ARI) being developed by GlaxoSmithKline for the treatment of BPH were presented for the first time today at the XVIIth Congress of the EAU in Birmingham, UK.

BPH, one of the most common medical health problems in men, is a progressive condition in which the central part of the prostate gland enlarges thereby squeezing and distorting the urethra as it passes through the prostate. The disease produces a combination of 'obstructive' and 'irritative' symptoms and is also associated with several complications including worsening of lower urinary tract infections, episodes of acute urinary retention and need for surgery.

Pooled 2-year results of clinical trials, involving over 4,000 patients, showed that dutasteride had a long-term positive impact on BPH progression over the 2-year period compared with placebo. The new data showed that dutasteride significantly:

- Reduced prostate volume as early as one month continuing through 3, 6, 12 and 24 months,
- Improved lower urinary tract symptoms at 6, 12, 18 and 24 months compared to placebo
- Improved urinary flow measurements versus placebo as soon as 1 month in a pooled analysis and at 3, 6, 12 and 24 months in individual studies,
- Reduced the risk of acute urinary retention by 57% versus placebo,
- Reduced the risk of BPH-related surgical intervention by 48% versus placebo,
- Was well tolerated, with withdrawals due to drug-related adverse events only slightly higher than in the placebo group (4% vs. 3% for the dutasteride and placebo groups, respectively).

"These latest results suggest that dutasteride has a significant effect on BPH progression and can help meet certain long-term objectives for BPH treatment." said Dr Claus Roehrborn, from the University of Texas Southwest Medical Centre, Dallas, Texas.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Notes to Editors

Dutasteride is a new dual inhibitor of the 5 alpha reductase isoenzymes, types 1 and 2, which have been shown to play a key role in the conversion of testosterone to dihydrotestosterone (DHT). DHT is central to the development of BPH and its related symptoms.

• Phase III trials presented were randomised, double-blind, two-year parallel group studies which evaluated the efficacy and safety of dutasteride in the treatment and modification of BPH progression in 4,325 patients in 19 countries, including the USA. Men over 50 years with moderate to severe urinary symptoms and a prostate volume of ³30cc were included.

   

• Complications such as acute urinary retention and BPH-related surgery are widely recognised as BPH progression endpoints.

   

• Alpha-blockers and 5ARIs are the main medical therapies for the treatment of BPH. However there are no rigorous data to suggest that alpha-blockers can prevent episodes of acute urinary retention or prevention or progression of the disease.

   

• At present 10 percent of 40 year-old men, 75 percent of men aged over 50 years and 90 percent of men over the age of 80 suffer from symptoms of BPH. The prevalence of BPH is predicted to increase by 45% over the next ten years.

   

• A 60-year old man has a 23% lifetime risk of going into AUR if he lives another 20-years.