The Pharmaceutical Journal
Vol 269 No 7218 p477
5 October 2002

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26th meeting of the International Society of Urology (more)

New drug provides relief for patients with benign prostatic hyperplasia

Dutasteride, a 5a-reductase inhibitor, reduces enlargement of the transitional zone of the prostate in patients with benign prostatic hyperplasia as early as one month into treatment, new data show.

In such patients enlargement of this zone of the prostate squeezes and distorts the urethra, causing symptoms such as decreased urinary flow, episodes of urinary retention and urinary tract infections.

Dutasteride works by reducing circulating levels of dihydrotestosterone, thereby preventing complications of disease progression and alleviating symptoms.

Researchers assigned 4,325 men with moderate to severe symptoms of benign prostatic hyperplasia to receive dutasteride 0.5mg daily or placebo. They found that dutasteride reduced transitional zone volume by a median of 5.0 per cent after one month and by 25.5 per cent after two years. No significant changes were reported in the placebo group.

In another study, researchers assigned 327 men with benign prostatic hyperplasia from six countries, including the United Kingdom, to receive a combination of dutasteride 0.5mg plus tamsulosin, an alpha-blocker, once daily for 24 weeks. Participants were then randomly assigned either to continue their treatment regimen or to receive dutasteride plus placebo for 12 weeks.

They found that 77 per cent (n=149) of patients who were switched to the dutasteride plus placebo treatment group reported feeling the same or better six weeks after the change in treatment. The remaining 23 per cent reported feeling worse.

Of those who continued taking dutasteride plus tamsulosin, 91 per cent (n=154) reported that their symptoms were the same or had improved whereas 9 per cent felt worse.

Data were presented at the 26th meeting of the International Society of Urology held in Stockholm last month.

Dutasteride is being developed by GlaxoSmithKline and is expected to be launched in the UK later this year for the treatment of benign prostatic hyperplasia as well as the prevention of acute urinary retention and surgery in patients with benign prostatic hyperplasia.