Dutasteride for the treatment of benign prostatic hyperplasia.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is an age-related phenomenon associated with prostatic enlargement and bladder outlet obstruction that can cause significant lower urinary tract symptoms that greatly affect quality of life. Dutasteride is a selective inhibitor of type 1 and type 2 isoforms of 5-α-reductase, an enzyme responsible for the conversion of testosterone to 5-α-dihydrotestosterone, approved as a treatment for symptomatic BPH. AREAS COVERED: This article will cover the efficacy and safety of dutasteride in the treatment of BPH, with focus on landmark trials conducted on this drug. Medical literature on the use of dutasteride in men with BPH were identified by searching databases since 1996 (including MEDLINE and EMBASE) as well as bibliographies from published literature, clinical trial registries and manufacturer and federal drug regulatory websites. EXPERT OPINION: Dutasteride is an effective, safe and well-tolerated treatment either as monotherapy or in combination with an α-blocker, for the management of symptomatic BPH to improve symptoms, reduce the risk of acute urinary retention and risk for BPH-related surgery. A new prostate-specific antigen baseline should be established after 6 months of therapy for clinical decision making. The relationship between dutasteride and high-grade prostate cancer is not clear, and dutasteride is not approved for prostate cancer chemoprevention.