Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Nephrology | Family Medicine | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 2001
Treatment Area: Symptomatic benign prostatic hyperplasia
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
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 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
Mechanism of Action
Dutasteride is a 5-alpha-reductase enzyme inhibitor that
inhibits both type 1 and type 2 isoenzymes.