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Expert Opin Drug Saf. 2012 Mar;11(2):325-30. doi: 10.1517/14740338.2012.658040. Epub 2012 Feb 8.

Dutasteride for the treatment of prostate-related conditions.

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  • 1Beth Israel Deaconess Medical Center, Harvard Medical School, Division of Hematology/Oncology, Boston, MA, USA.



A variety of pharmaceuticals have been developed directed at mitigating the symptoms associated with benign prostatic hypertrophy (BPH) and have also been evaluated for their potential role in prevention and treatment of prostate cancer. One such agent is dutasteride , a non-selective inhibitor of 5α-reductase, an enzyme responsible for conversion of testosterone to a more potent androgen dihydrotestosterone (DHT).


This review will cover the safety profile of dutasteride when it is used in the treatment of prostate-related conditions, specifically looking at the pivotal clinical trials on this drug.


Dutasteride has proved to be a safe and efficacious treatment for symptoms related to BPH. The primary safety concern relates to the increased incidence of high-grade prostate cancer seen in men treated with dutasteride in the setting of prostate cancer prevention. Dutasteride has a role as an adjunct in the treatment of prostate cancer; however, this is an area still under active investigation. It is not recommended for use in prostate cancer prevention given the increased risk of high-grade cancers.

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