Dutasteride: A Review of Its Use in the Management of Prostate Disorders

The document from 2011 reviewed Dutasteride, a medication used to treat men with symptomatic benign prostatic hyperplasia (BPH) and an enlarged prostate. It is effective as both monotherapy and in combination with tamsulosin, as shown in randomized trials and their extensions. Dutasteride significantly reduces the risk of acute urinary retention and the need for BPH-related surgery, and it may also lower the risk of prostate cancer development. The document cites a trial with 4,325 men where Dutasteride reduced serum dihydrotestosterone (DHT) levels by over 90% at two years and decreased the risk of acute urinary retention and surgery compared to placebo. Side effects were more common with Dutasteride but were generally manageable. The CombAT study indicated that combination therapy was more effective than monotherapy for symptom improvement. The REDUCE trial showed a 22.8% relative risk reduction in prostate cancer over four years with Dutasteride use. However, the FDA's Oncologic Drugs Advisory Committee voted against its use for chemoprevention due to an insufficient benefit-to-risk ratio. Clinical trials have confirmed that Dutasteride is safe and well-tolerated, with sexual side effects decreasing over time. Despite its benefits, Dutasteride is not approved for prostate cancer chemoprevention, and further research is needed to clarify its role in this area.