The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved November 2001

Specific Treatments:

Symptomatic benign prostatic hyperplasia

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General Information

Dutasteride capsules have been approved by the FDA for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland. Dutasteride is a dual 5-alpha-reductase inhibitor, blocking both type 1 and type 2 5-alpha-reductase isoenzymes. These enzymes are responsible for converting testosterone into dihydrotestosterone (DHT) in the prostate. In turn, high levels of DTH may accumulate and cause hyperplasia.

BPH is a non-cancerous enlargement of the prostate gland, which can lead to the development of lower urinary tract symptoms. According to the National Kidney and Urologic Diseases Information Clearinghouse, more than half of men in their sixties and as many as 90% in their seventies and eighties have some symptoms of BPH. Symptoms of BPH vary, but can include urination problems such as urgency and leaking or dribbling, or more frequent urination, especially at night.

Clinical Results

Clinical testing for dutasteride included over 4,300 subjects with BPH. Results have demonstrated that the drug provides long lasting symptom relief and positively impacts disease progression.

Mechanism of Action

Dutasteride is a 5-alpha-reductase enzyme inhibitor that inhibits both type 1 and type 2 isoenzymes.

Additional Information

For additional information on dutasteride, please visit GlaxoSmithKline at www.gsk.com.

More information on BPH can be obtained through the National Kidney and Urologic Diseases Information Clearinghouse.